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Complexity of Protein-Protein Interactions, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)

Complexity of Protein-Protein Interactions

Curator: Larry H. Bernstein, MD, FCAP

Cracking the Complex

Using mass spec to study protein-protein interactions

By Jeffrey M. Perkel | November 1, 2015

http://www.the-scientist.com//?articles.view/articleNo/44317/title/Cracking-the-Complex/

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Mass spectrometry is a proteomics workhorse. By precisely measuring polypeptide masses, researchers can identify and sequence those molecules, and characterize whether and how they have been chemically modified. To twist a phrase, by their masses you shall know them.

But many proteins do not act in isolation. Critical biological processes such as DNA replication, transcription, translation, cell division, and energy generation rely on the action of massive protein assemblies, many of which comprise dozens of subunits. While these clusters are ripe for study, few traditional mass spectrometric methods can handle them.

Indeed, protein complexes are unwieldy for many types of analysis, says Philip Compton, director of instrumentation at the Proteomics Center of Excellence at Northwestern University in Evanston, Illinois. Most complexes are held together by noncovalent interactions, assemble only transiently, or are located in the cell membrane—all of which complicate sample preparation, he explains. Also, while some complexes are relatively abundant, others are rare, further thwarting detection and analysis.

For mass spectrometry specifically, however, the problem with analyzing protein complexes, which can weigh in at 500 kDa, is size. “In a mass spec, things of that size have traditionally been fairly difficult to handle,” Compton says. Even if you can deliver them into the spectrometer itself, you need a way to figure out which proteins are present, and in what stoichiometry. Plus, normal sample preparation procedures tend to denature proteins, ripping complexes apart.

Still, researchers are increasingly keen to train their mass specs on intact protein assemblies. The Scientistasked four protein-complex experts about the approaches they use in their own labs. This is what they said.

Determining subunit composition 

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GETTING TOGETHER: Lactate dehydrogenase from human skeletal muscle comprises four identical M subunits, shown here in different colors.  FVASCONCELLOS/WIKIMEDIA COMMONS

RESEARCHER: Philip Compton, Director of Instrumentation, Proteomics Center of Excellence, Northwestern University

PROJECT: High-throughput top-down proteomics

SOLUTION: If protein complexes are onions, Compton needs a way to iteratively peel off the layers to see what’s inside. Working with researchers at Thermo Fisher Scientific, Compton is developing an Orbitrap-based mass spectrometer that can do just that, or perform what is called an MS3 study.

Basically, an MS3 experiment involves weighing all the complexes in a sample fraction—there could be as many as 10 or 15 at a time—grabbing one, smashing it into inert-gas molecules to eject a subunit, weighing and sequencing the cast-off piece, and then repeating the process.

That’s the goal, but because that instrument is not yet built, Compton must temporarily content himself with what he calls a “pseudo-MS3” experiment. Basically, instead of one seamless workflow, the instrument shatters the complex, weighs the pieces that come off it, and then repeats the process, only this time capturing and fragmenting those ejected pieces for subsequent analysis (Anal Chem, 85:11163-73, 2013). “We’re kind of splitting it into these two different steps; that accomplishes essentially the same thing,” Compton says.

Compton and his team are still ironing out the kinks, but they have begun applying the approach to protein complexes involved in metabolism. One of these, lactate dehydrogenase (LDH), is a 145-kDa tetramer comprising M (muscle) and H (heart) subunits that can exist in any of five configurations (MMMM, MMMH, MMHH, MHHH, and HHHH). Using the MS3 workflow, Compton says he can differentiate these “multiproteoform assemblies,” as well as any posttranslational modifications those subunits may bear, and determine the abundance of each. Now he hopes to apply the approach to quantify LDH differences between cell and tissue types.

From Protein Complexes to Subunit Backbone Fragments: A Multi-stage Approach to Native Mass Spectrometry

Thermo Fisher Scientific, 28199 Bremen, Germany
Northwestern University, Evanston, Illinois 60208, United States
Anal. Chem., 2013, 85 (23), pp 11163–11173    DOI: http://dx.doi.org:/10.1021/ac4029328
Publication Date (Web): November 15, 2013   Copyright © 2013 American Chemical Society
Abstract Image
Native mass spectrometry (MS) is becoming an important integral part of structural proteomics and system biology research. The approach holds great promise for elucidating higher levels of protein structure: from primary to quaternary. This requires the most efficient use of tandem MS, which is the cornerstone of MS-based approaches. In this work, we advance a two-step fragmentation approach, or (pseudo)-MS3, from native protein complexes to a set of constituent fragment ions. Using an efficient desolvation approach and quadrupole selection in the extended mass-to-charge (m/z) range, we have accomplished sequential dissociation of large protein complexes, such as phosporylase B (194 kDa), pyruvate kinase (232 kDa), and GroEL (801 kDa), to highly charged monomers which were then dissociated to a set of multiply charged fragmentation products. Fragment ion signals were acquired with a high resolution, high mass accuracy Orbitrap instrument that enabled highly confident identifications of the precursor monomer subunits. The developed approach is expected to enable characterization of stoichiometry and composition of endogenous native protein complexes at an unprecedented level of detail.

EXTEND YOUR RANGE: Compton’s team uses a souped-up version of Thermo Fisher’s Orbitrap-based Q Exactive HF mass spectrometer, which among other things features a fourfold wider mass range. Other researchers can perform similar work using Thermo’s Exactive Plus EMR Orbitrap system, an off-the-shelf, “extended mass range” instrument. But, because the EMR lacks the “high-mass isolation capabilities” of Compton’s bespoke hardware, the application range is more limited, he says. “You can still do a similar experiment to us, provided that you have one clean [purified] complex.”

Mapping protein-protein interaction interfaces
RESEARCHER: Igor Kaltashov, Professor of Chemistry, University of Massachusetts Amherst

PROJECT: Probing the interactions of candidate protein therapeutics with their molecular targets

SOLUTION: Most attempts at studying protein complexes deliver them to the mass spec intact. Kaltashov takes a different approach, using a technique called hydrogen-deuterium exchange (HDX).

It works like this: proteins (like other molecules) pass hydrogen atoms back and forth with the solvent that surrounds them. Normally, one hydrogen is simply swapped for another, and nobody is the wiser. But in deuterated (“heavy”) water, as hydrogens are swapped at the protein surface, the protein gets slightly heavier as deuterium molecules replace some of the hydrogens. This allows researchers to probe how accessible different pieces of the protein are to the solvent, based on how much deuterium they pick up from the buffer, and how quickly they do so.

As Kaltashov explains, HDX can be used to study any event that might alter the accessibility of different protein regions to the solvent that surrounds them. Those events include protein folding and aggregation, but also protein-protein interactions. “Once two proteins bind to each other, solvent would be excluded from the interface, and that would be reflected in the hydrogen-deuterium exchange kinetics,” he says. That change is evident when compared to the proteins in isolation.

In a 2009 review, Kaltashov demonstrated the process with transferrin, an iron transport protein, and its receptor. After undergoing the exchange reaction, the proteins were fragmented to peptides and analyzed piecemeal. Some peptides exhibited no hydrogen-deuterium exchange, he says. That suggests they were never exposed to solvent because they were buried inside the protein core. Other peptides exchanged hydrogens with the solvent at the same rate regardless of receptor binding, indicating they are not part of the protein-receptor interface. A third set of peptides, though, exhibited clear differences in the presence and absence of receptor, marking those as elements of the protein-protein interaction domain (Anal Chem, 81:7892-99, 2009).

“You can actually localize these sites and obtain information both on the strength of the binding [interactions] and the structural characteristics of the interface region,” Kaltashov says.

H/D exchange and mass spectrometry in the studies of protein conformation and dynamics: Is there a need for a top-down approach?

Hydrogen/deuterium exchange (HDX) combined with mass spectrometry (MS) detection has matured in recent years to become a powerful tool in structural biology and biophysics. Several limitations of this technique can and will be addressed by tapping into ever expanding arsenal of methods to manipulate ions in the gas phase offered by mass spectrometry.

Keywords: hydrogen/deuterium exchange (HDX), mass spectrometry (MS), protein ion fragmentation, collision-induced dissociation (CAD), electron-capture dissociation (ECD), electron-transfer dissociation (ETD), protein conformation, protein dynamics

Introduction: HDX MS in the context of structural proteomics

The spectacular successes of proteomics and bioinformatics in the past decade have resulted in an explosive growth of information on the composition of complex networks of proteins interacting at the cellular level and beyond. However, a simple inventory of interacting proteins is insufficient for understanding how the components of sophisticated biological machinery work together. Protein interactions with each other, small ligands and other biopolymers are governed by their higher order structure, whose determination on a genome scale is a focus of structural proteomics. Realization that “the structures of individual macromolecules are often uninformative about function if taken out of context”1 is shifting the focus of the inquiry from comprehensive characterization of individual protein structures to structural analysis of protein complexes.

X-ray crystallography remains the mainstay in this field, and high resolution structures of proteins and protein complexes often provide important clues as to how they carry out their diverse functions in vivo. However, individual proteins are not static objects, and their behavior cannot be adequately described based solely on information derived from static snapshots and without taking into consideration their dynamic character.2Conformation and dynamics of small proteins can be probed at high spatial resolution on a variety of time scales using NMR spectroscopy; however, rather unforgiving molecular weight limitations make this technique less suited for the studies of larger proteins and protein complexes.

Mass spectrometry (MS) is playing an increasingly visible role in this field, as it can provide information on protein dynamics on a variety of levels, ranging from interactions with their physiological partners by forming dynamic assemblies3 to large-scale conformational transitions within individual subunits.4 Perhaps one of the most powerful MS-based tools to characterize protein conformation and dynamics is HDX MS, a technique that combined hydrogen/deuterium exchange in solution5 with MS detection of the progress of exchange reactions.6 This technique is certainly not new,7 and in fact already made lasting impact in diverse fields ranging from structural proteomics8 to analysis of biopharmaceutical products.9 Nevertheless, HDX MS methodology is still in a phase where dramatic progress is made, fed by the continued expansion of the experimental armamentarium offered by MS. In particular, better integration of new methods of manipulating ions in the gas phase into HDX MS routine is likely to result in truly transformative changes. This sea change in HDX MS methodology will transform it to a potent tool rivaling NMR in terms of resolution, but without suffering the limitations of this technique.

What information can be deduced from HDX MS measurements? The classic “bottom-up” approach, its challenges and limitations

While the concept of HDX experiment may appear rather transparent (Figure 1), interpretation of the results is usually not. The backbone protection measured in a typical HDX MS experiment is a combination of several factors, as the exchange reaction of each labile hydrogen atom is a convolution of two processes.5The first is a protein motion that makes a particular hydrogen atom exposed to solvent and therefore available for the exchange. This could be a small-scale event, such as relatively frequent local structural fluctuations transiently exposing hydrogen atoms residing close to the protein surface, or a rare global unfolding event exposing atoms sequestered from the solvent in the protein core. The second process is a chemical reaction of exchanging the unprotected labile hydrogen atom with the solvent. The kinetics of this reaction (intrinsic exchange rate) strongly depends on solution temperature and pH (with a minimum at pH 2.5-3 for backbone amides), parameters that obviously have a great influence on the protein dynamics as well.

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Schematic representation of HDX MS experiments: bottom-up (A) and top-down (B) HDX MS.

Since the majority of HDX MS studies target protein dynamics under near-native conditions, the experiments are typically carried out at physiological pH, where the progress of the exchange is followed by monitoring the protein mass change. The direct infusion scheme offers the simplest way to carry out such measurements, either in real time7 or by using on-line rapid mixing.10 However, in many cases these straightforward approaches cannot be used, as they limit the choice of exchange buffer systems to those compatible with electrospray ionization (ESI). To avoid this, HDX can be carried out in any suitable buffer followed by rapid quenching (lowering pH to 2.5-3 and temperature to near 0°C). Dramatic deceleration of the intrinsic exchange rate for backbone amides under these conditions allows the protein solution to be de-salted prior to MS analysis. Additionally, the slow exchange conditions denature most proteins, resulting in facile removal of various binding partners, ranging from small ligands to receptors (their binding to the protein of interest inevitably complicates the HDX MS data interpretation by making accurate mass measurements in the gas phase less straightforward).

An example of such experiments is shown in Figure 2, where HDX is used to probe the higher order structure and conformational dynamics of metal transporter transferrin (Fe2Tf) alone and in the receptor-bound form. Both Tf-metal and Tf-receptor complexes dissociate under the slow exchange conditions prior to MS analysis; therefore, the protein mass evolution in each case reflects solely deuterium uptake in the course of exchange in solution. The extra protection afforded by the receptor binding to Tf persists over an extended period of time, and it may be tempting to assign it to shielding of labile hydrogen atoms at the protein-receptor interface. However, this view is overly simplistic, as the conformational effects of protein binding are frequently felt well beyond the interface region. The difference in the backbone protection levels of receptor-free and receptor-bound forms of Fe2Tf appears to grow during the initial hour of the exchange (Figure 2), reflecting significant stabilization of Fe2Tf higher order structure by the receptor binding. Indeed, while the fast phase of HDX is typically ascribed to frequent local fluctuations (transient perturbations of higher order structure) affecting relatively small protein segments, the slower phases of HDX usually reflect relatively rare, large-scale conformational transitions (transient partial or complete unfolding). This is why global HDX MS measurements similar to those presented in Figure 2 are can be used to obtain quantitative thermodynamic characteristics for protein interaction with a variety of ligands, ranging from metal ions11 and small organic molecules 12 to other proteins13 and oligonucleotides.14

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HDX MS of Fe2Tf in the presence (blue) and the absence (red) of the cognate receptor. The exchange was carried out by diluting the protein stock solution 1:10 in exchange solution (100 mM NH4HCO3 in D2O, pH adjusted to 7.4) and incubating for a certain period of time as indicated on each diagram followed by rapid quenching (lowering pH to 2.5 and temperature to near 0°C). The black trace shows unlabeled protein.

While global HDX MS measurements under near-native conditions provide valuable thermodynamic information on proteins and their interaction with binding partners, structural studies (e.g., localizing the changes in Tf that occur as a result of receptor binding) must rely on the knowledge of exchange kinetics at the local level. This is typically accomplished by carrying out proteolysis under the slow exchange conditions following the quench of HDX.6 Here we will refer to this approach as “bottom-up” HDX MS, by drawing analogy to a bottom-up approach to obtain sequence information.15 An example is shown in Figure 3, where Fe2Tf undergoes exchange in solution in the absence and in the presence of the receptor, followed by rapid quenching of HDX reactions, protein reduction and digestion with pepsin and LC/MS analysis of the deuterium content of individual proteolytic peptides.

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Localizing the influence of the receptor binding on backbone protection of Fe2Tf using bottom-up HDX MS on the physiologically relevant time scale. The panels show isotopic distributions of representative peptic fragments derived from the protein subjected to HDX in the presence (blue) and the absence (red) of the receptor and followed by rapid quenching. Dotted lines indicate deuterium content of unlabeled and fully exchanged peptides. Colored segments within the Fe2Tf/receptor complex show location of the peptic fragments.

Evolution of deuterium content of various peptic fragments in Figure 3 reveals a wide spectrum of protection, which is clearly distributed very unevenly across the protein sequence. While some peptides exhibit nearly complete protection of backbone amides (e.g., segment [396-408] sequestered in the core of the protein C-lobe), exchange in some other segments is fast (e.g., peptide [612-621] in the solvent-exposed loop of the C-lobe). The influence of the receptor binding on the backbone protection is also highly localized. While many segments appear to be unaffected by the receptor binding, there are a few regions where exchange kinetics noticeably decelerates (e.g., segment [71-81] of the N-lobe, which contains several amino acid residues that form Tf/receptor interface according to the available model of the complex based on low-resolution cryo-EM data16).

Although the increased protection of backbone amides proximal to the protein/receptor binding interface is hardly surprising, HDX MS data also reveal a less trivial trend, acceleration of exchange kinetics in some segments of the protein as a result of receptor binding (such behavior is illustrated in Figure 3 with segment [113-134], a part of the N-lobe that is distal to the receptor). Therefore, in addition to mapping binding interface regions, HDX MS also provides a means to localize the protein segments that are affected by the binding indirectly via allosteric mechanisms. However, this example also highlights one of the limitations of HDX MS, namely inadequate spatial resolution. This peptic fragment spans several distinct regions of the protein (an α-helical segment, a β-strand, and two loops). The moderate level of protection observed in this segment in the absence of the receptor binding (fast exchange of three protons followed by slow exchange of the rest) is likely to be a result of averaging out very uneven protection patterns across this peptide. Even smaller peptides may comprise two or more distinct structural elements, such as segment [71-81] spanning three distinct regions of the protein (an α-helical segment, a β-strand, and a loop connecting them).

In some favorable cases spatial resolution in HDX MS of small proteins (<15 kDa) may be enhanced up to a single residue level by analyzing deuterium content of a set of overlapping proteolytic fragments.17However, single-residue resolution has never been demonstrated in HDX MS studies of proteins falling out of the mass range routinely accessible by NMR, although overlapping peptic fragments frequently provide moderate improvement of spatial resolution.

In addition to limited spatial resolution, the “classic” HDX MS scheme frequently suffers from incomplete sequence coverage, especially when applied to larger and extensively glycosylated proteins. Proteins with multiple disulfide bonds constitute another class of targets for which adequate sequence coverage is difficult to achieve, although certain changes in experimental protocol can alleviate this problem, at least for smaller proteins.18 Typically, an 80% level of sequence coverage is considered good, although significantly lower levels may also be adequate, depending on the context of the study.

Protein processing in HDX MS experiments is carried out under the conditions that minimize the exchange rates for backbone amides. Since these slow exchange conditions are highly denaturing for most proteins, both intact protein and its proteolytic fragments lack any protection and inevitably begin to lose their labile isotopic labels, despite low (but finite) intrinsic exchange rates.19 This phenomenon, known as “back-exchange,” may be accelerated during various stages of protein processing, e.g. during the chromatographic step.20 Although back-exchange was frequently evaluated in early HDX MS studies using unstructured model peptides, the utility of this procedure is questionable, since the intrinsic exchange rates are highly sequence-dependent. In many instances, back-exchange may be estimated using algorithms based on context-specific kinetics data (e.g., http://hx2.med.upenn.edu/download.html); it may also be determined experimentally for each proteolytic fragment by processing a fully labeled protein using a series of steps that precisely reproduce those used in HDX MS measurements.9 Typical back-exchange levels reported in recent literature range from 10% to 50%, although significantly higher numbers have also been reported. Even if back-exchange can be accounted for, it nonetheless has very detrimental influence on the quality of HDX MS measurements by reducing the available dynamic range.

Finally, the classic HDX MS scheme is poorly suited for measurements that are carried out under conditions favoring correlated exchange, when HDX kinetics follows the so-called EX1 regime, leading to appearance of bimodal and convoluted multi-modal isotopic distributions of protein ions.21 Carrying out HDX MS measurements under these conditions provides a unique opportunity to visualize and characterize distinct conformational states, which can be populated either transiently10 or at equilibrium.22 The distinction among such states can be made based on the differences in their deuterium contents. However, proteolysis in solution almost always leads to a loss of correlation between the deuterium content of fragment peptides and specific conformers with distinct levels of backbone protection. Therefore, the classic HDX MS scheme does not allow protein higher order structure and dynamics to be characterized in a conformer-specific fashion.

“Top-down” HDX MS: tandem MS allows protein structure to be probed in the conformer-specific fashion but raises the specter of hydrogen scrambling

The problem of characterizing protein conformation and dynamics in a conformer-specific fashion can be addressed using methods of tandem mass spectrometry (the so-called “top-down” HDX MS). Indeed, replacement of proteolysis in solution with protein ion fragmentation in the gas phase following mass selection of precursor ions provides a means to obtain fragment ions originating from a particular conformer with a specific level of deuterium incorporation. Deuterium content of fragment ions would then provide a measure of local protection patterns, assuming there is no internal re-arrangement of labile hydrogen and deuterium atoms during ion activation (vide infra). Although the idea to use polypeptide ion dissociation in the gas phase as an alternative to proteolysis was originally proposed in early 1990s,23 its implementation for proteins only became possible24 following dramatic improvements in FTMS and hybrid TOF analyzers in the late 1990s.

An example of conformer-specific characterization of protein higher order structure using a top-down HDX MS approach is illustrated in Figure 4. The isotopic profile of a fully deuterated 18 kDa protein wt*-CRABPI is recorded following its brief exposure to the 1H-based exchange buffer. The bimodal appearance of the isotopic distribution of the molecular ion (top trace in Figure 4A) clearly indicates the presence of at least two conformers with different levels of backbone protection. Collisional activation of the entire protein ion population generates a set of fragment ions with convoluted isotopic distributions (top trace in Figure 4B). However, mass selection of precursor ions with a specific level of deuterium content allows the top-down HDX MS measurements to be carried out in a conformation-specific fashion, taking full advantage of the HDX MS ability to detect distinct conformers. For example, selective fragmentation of protein ions representing a highly protected conformation is achieved by mass-selecting a narrow population of intact protein ions with high level of retained deuterium (the blue trace in Figure 4A). Mass-selection and subsequent fragmentation of a narrow population of protein ions with significantly lower deuterium content (the red trace in Figure 4A) generates a set of fragment ions whose isotopic distributions provide information on backbone protection within non-native protein states. For example, the data presented in Figure 4 clearly indicate that the C-terminal segment of the protein represented by the y172+ ions retains significant structure even within the partially unfolded conformers: the amount of retained deuterium atoms reduces by only 30% as a result of switching from the precursor ion from highly protected (blue) to less protected (red). At the same time, selection of the precursor ion has a much more dramatic effect on the protection levels exhibited by the N-terminal segment (represented by the b425+ ion), where more than a two-fold decrease in the amount of retained deuterium atoms is observed. Extending this analysis to other protein fragments may allow detailed backbone protection maps to be created for each protein conformer, provided there is no hydrogen scrambling prior to protein ion fragmentation (vide infra).

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Characterization of local dynamics in wt*-CRABP I in a conformer-specific fashion using top-down HDX MS (fully deuterated protein was exposed to 1H2O/CH3CO2N1H4 at pH 3.1 for 10 min; the gray trace at the bottom corresponds to HDX end-point). A: mass selection of precursor ions for subsequent CAD (from top to bottom): broad-band selection of the entire ionic population (not conformer-specific); highly protected conformers; narrow population of less protected conformers; HDX end-point. B: isotopic distributions of two representative fragment ions generated by CAD of precursor ions shown in panel A. Selection of different ion populations as precursor ions for subsequent fragmentation was achieved by varying the width of a mass selection window of a quadrupole filter (Q) in a hybrid quadrupole/time-of-flight mass spectrometer (Qq-TOF MS).

The example shown above illustrates a great promise of top-down HDX MS as a technique uniquely capable of probing structure and dynamics of populations of protein conformers coexisting in solution with high selectivity. Furthermore, this approach often allows one to avoid protein handling under the slow exchange conditions prior to MS analysis, thereby eliminating back-exchange as a factor adversely influencing the quality of measurements. Nonetheless, applications of top-down HDX MS have been limited due to concerns over the possibility of hydrogen scrambling accompanying collision-activated dissociation (CAD) of protein ions. Indeed, several reports pointed out that proton mobility in the gas phase may under certain conditions influence the outcome of top-down HDX MS measurements when CAD is employed to fragment protein ions.25, 26

The occurrence (or the absence) of hydrogen scrambling in the gas phase can be reliably detected by using built-in scrambling indicators. One particularly convenient indicator is a Histag, a 6-30 residues long, histidine-rich segment appended to wild-type sequences to facilitate protein purification on metal affinity columns. Such segments are fully unstructured in solution and, therefore, should lack any backbone protection.27 Alternatively, intrinsic scrambling indicators (e.g., internal flexible loops26), as well as other approaches25 can be used to detect occurrence of scrambling. The available experimental evidence suggests that slow protein ion activation (e.g., SORI CAD) always leads to hydrogen scrambling, while fast activation allows it to be minimized or eliminated in top-down HDX MS experiments.26

Another shortcoming of top-down HDX MS schemes utilizing CAD is the limited extent of protein ion fragmentation, which may lead to sizeable gaps in sequence coverage, particularly for larger proteins,28 and insufficient level of spatial resolution (even for smaller proteins29). Our earlier attempts to solve this problem by employing multi-stage CAD (MSn) were unsuccessful due to massive hydrogen scrambling exhibited by the second generation of fragments.

Electron-induced ion fragmentation in top-down schemes: keeping hydrogen scrambling at bay while enhancing sequence coverage and spatial resolution

Some time ago we suggested that the specter of hydrogen scrambling in top-down HDX MS measurements may be alleviated by using non-ergodic fragmentation processes, where dissociation is induced by ion-electron interaction, rather than collisional activation.30 Indeed, the results of earlier work combining hydrogen exchange of polypeptide ions in the gas phase and electron capture dissociation (ECD) were consistent with the notion of intramolecular rearrangement of hydrogen atoms occurring on a slower time scale compared to ion dissociation.31 A recent study demonstrated that the extent of scrambling was indeed negligible when ECD was used as a means to obtain fragment ions in top-down HDX MS characterization of a small protein ubiquitin.32

Our own recent work suggests that hydrogen scrambling can be avoided when top-down HDX MS employs ECD in characterizing higher order structure of larger proteins (approaching 20 kDa), although experimental conditions must be carefully controlled to minimize proton mobility induced by ion-molecule collisions in the ESI interface. The point in question is illustrated in Figure 5, which shows the results of top-down HDX MS analysis of higher order structure of wt*-CRABP I. The protein retains a significant proportion of labile deuterium label following its complete deuteration and then brief exposure to the 1H-based exchange buffer, as indicated by the isotopic distribution of the surviving molecular ions (red and blue traces in Figure 5A). However, the deuterium content of fragment ions derived from the 21-residue long His-tag region of the protein (e.g., c22 in Figure 5B) is indistinguishable from that of the exchange reaction endpoint, as long as moderate ion desolvation conditions are kept in the ESI interface. This clearly signals that hydrogen scrambling does not affect the outcome of local HDX MS measurements. However, once collision-assisted desolvation of protein ions is attempted in the ESI interface, the appearance of isotopic distributions of larger fragment ions derived from the His-tag region (e.g., c22, red trace in Figure 5B) shifts, indicating apparent deuterium retention and signaling the occurrence of limited hydrogen scrambling. We also demonstrated that deuterium distribution across the protein backbone is preserved when another recently introduced fragmentation technique based on cation-electron interactions, electron transfer dissociation (ETD), is used in top-down HDX MS schemes.33

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Top-down HDX MS of wt*-CRABP I using ECD of the entire protein ion population (fully deuterated protein was exposed to1H2O/CH3CO2N1H4 at pH 3.5 for varying time periods); the black trace at the bottom of corresponds to HDX end-point). A: isotopic distributions of surviving intact protein ions. B: two representative c-ions. Minimal collision-and temperature-induced desolvation was used for acquisition of all mass spectra, except the one top (red trace).

In addition to allowing scrambling to be easily eliminated in top-down HDX MS experiments, both ECD and ETD appear to be superior to CAD in terms of sequence coverage, at least for the proteins in the 20 kDa range. Unlike CAD, protein backbone cleavage in ECD and ETD is less specific,34 leading to a higher number of fragment ions. This translates not only to improved sequence coverage, but also enhanced spatial resolution. Indeed, in some cases it becomes possible to generate patterns of deuterium distribution across the protein backbone down to the single residue level.

One example of such work is shown in Figure 6, where ETD was used as a protein ion fragmentation tool in top-down HDX MS characterization of a 16 kDa variant of CRABP I. The bar graph shows the levels of deuterium retention in a series of c-ions derived from the N-terminal segment of the protein. The bar height at position n in this diagram shows mass difference between two cn-1 fragments, one derived from the fully deuterated protein that was exposed to the protiated exchange buffer at pH 7 for 5 min and then placed under the slow exchange conditions for the duration of the data acquisition cycle, and another one representing the HDX endpoint (raw data for bars at n=14 and 35 are shown in Figure 7). Unchanged height between two adjacent bars at residues n and n+1 indicates no difference in deuterium content of cn-1 and cn fragments, signaling no backbone amide deuterium retention at residue n+1, while bar height increase by one unit indicates complete retention of deuterium at the nth amide.

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Backbone protection pattern of CRABPI mutant (without N-terminal His-tag) obtained from top-down HDX MS measurements using ETD of the entire protein ion population. HDX was initiated by exposing the fully deuterated protein to 1H2O/CH3CO2N1H4 at pH 3.5 for 5 min followed by rapid quenching.

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An example of raw HDX MS data used to generate the protection plot shown in Figure 6. Isotopic distributions of c13 and c34 fragments derived from protein subjected to 5 min HDX exchange in solution (red trace) and protein at the HDX end-point (blue trace) were used to calculate the bar heights at n=12 and 35.

The resulting backbone protection pattern in Figure 6 shows clear correlation with the known higher order structure of the protein (the amino acid sequence and the secondary structure assignment are shown at the top of the graph). Furthermore, the diagram clearly shows uneven distribution of backbone protection even within single structural elements (e.g., lower protection at the fringes vs. the middle of helix α1), as well as unequal protection of similar structural elements participating in the same structural motif (e.g., lower protection of helix α2 vs. helix α1, consistent with the available NMR data). A comparable level of spatial resolution can be achieved with ECD, as shown recently in top-down HDX MS analysis of higher order structure of myoglobin.35

The ability to characterize protein conformation and dynamics at the single residue level is certainly very exciting; however, it comes at a price. Since the protein fragmentation is carried out entirely in the gas phase, no fragment separation can be done prior to mass analysis. A large number of fragment ions with different masses and charges are usually confined to a relatively narrow m/z region, leading to inevitable overlaps of fragment ion isotopic distributions (Figure 7). This places rather stringent requirements on the resolving power of the mass analyzer, effectively narrowing the selection of mass spectrometers suitable for this work to FTMS.

Meeting in the middle: integration of top-down strategies into bottom-up HDX MS schemes

The top-down approach to HDX MS measurements clearly shows a promise to solve many problems that mar the commonly employed bottom-up methodology. The fragmentation efficiency afforded by ECD and ETD provides better spatial resolution, at least for proteins in the 20 kDa range, and this number is likely to grow as there are numerous examples of successful use of these fragmentation techniques to obtain sequence information on significantly larger proteins.36 Unlike the classic bottom-up approach, top-down HDX MS provides an elegant solution to the problem of characterizing higher order structure and dynamics in a conformer-specific fashion (see Figure 4 and discussion in the text). Finally, back-exchange can be eliminated, as outsourcing protein fragmentation to the gas phase often eliminates the need to manipulate the protein in solution under the slow exchange conditions prior to MS analysis.

The top-down/bottom-up dichotomy in HDX MS should not be viewed through the “eitheror” prism. In fact, gas phase fragmentation can enhance the quality of HDX MS data derived from experiments that are built around the bottom-up approach. The suggestion to supplement proteolysis in solution with peptide ion fragmentation in the gas phase to achieve better spatial resolution was made over 10 years ago.37 However, earlier attempts to implement this idea using CAD on a variety of platforms yielded mixed results due to apparent scrambling in some (but not all) fragment ions.37, 38 Later reports showed even more extensive scrambling in small peptide ions subjected to collisional activation,39 an obvious anathema to the proposed marriage of CAD and bottom-up HDX MS. Nonetheless, continued search for a scrambling-free solution to this problem has yielded very encouraging results, with both ECD and ETD showing minimal scrambling when applied to short peptides under carefully controlled conditions40, 41 and feasibility of supplementing proteolytic fragmentation in solution with ETD in the gas phase was recently demonstrated using a small model protein.42 Although these initial steps are relatively modest, they certainly warrant further work in this field.

The two complementary approaches to HDX MS measurements share a set of common challenges that inevitably arise as these techniques gain popularity and the scope of their applications expands. One such challenge is presented by membrane proteins, a notoriously difficult class of biological objects. HDX MS has been shown to have a great potential in this field.43 Interestingly, some initial work in this field was done nearly ten years ago using then-infant top-down HDX MS technique,44 while more recent work in this field utilizes both bottomup18 and top-down45 approaches. Another challenge faced by HDX MS is presented by highly heterogeneous proteins, such as proteins conjugated to other biopolymers and/or synthetic polymers, which constitute a significant fraction of the next generation of biopharmaceuticals. Presently, there are no biophysical techniques capable of characterizing conformation and dynamics of these systems, and there is an urgent need to fill this gap. Finally, nearly all HDX MS work reported to date was carried out in vitro under conditions that some regard as “reductionist.” Although initial HDX work with living objects was carried out over 75 years ago,46 as the years passed only one report on in vivo HDX MS studies was published.47 As mass spectrometry at large is being increasingly used in both in vivo and ex vivo studies, there is a growing pressure on HDX MS to follow the trend, although it remains to be seen how this will be done.

It probably is not an exaggeration to say that we are witnessing a renaissance of HDX MS, with the emergence of the top-down approach not only expanding our experimental arsenal by offering new capabilities, but also serving as a catalyst in enhancing the classic bottom-up methodology. The two techniques are highly complementary, and their synergism will certainly bring about new exciting discoveries and accelerate our progress in solving a variety of problems ranging from very fundamental questions in biophysics to applied problems in drug design.

see more at  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2805115/

WATCH OUT FOR DISULFIDES: If you’re going to try bottom-up HDX experiments, be careful of disulfide bonds, Kaltashov says. Pepsin is one of the very few proteinases that can efficiently digest a protein into its composite peptides under HDX experimental conditions, but it struggles when multiple disulfide bonds are present. In 2014, Kaltashov’s lab published two solutions to that problem. The first employs a fragmentation technique called electron capture dissociation (ECD) to break the disulfide linkage in the mass spec (Anal Chem, 86:5225-31, 2014); the second skips the pepsin digestion altogether—a strategy called top-down analysis (Anal Chem, 86:7293-98, 2014).

Enhancing the Quality of H/D Exchange Measurements with Mass Spectrometry Detection in Disulfide-Rich Proteins Using Electron Capture Dissociation

Anal Chem. 2014 Jun 3; 86(11): 5225–5231.   Published online 2014 May 12. doi:  10.1021/ac500904p
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Hydrogen/deuterium exchange (HDX) mass spectrometry (MS) has become a potent technique to probe higher-order structures, dynamics, and interactions of proteins. While the range of proteins amenable to interrogation by HDX MS continues to expand at an accelerating pace, there are still a few classes of proteins whose analysis with this technique remains challenging. Disulfide-rich proteins constitute one of such groups: since the reduction of thiol–thiol bonds must be carried out under suboptimal conditions (to minimize the back-exchange), it frequently results in incomplete dissociation of disulfide bridges prior to MS analysis, leading to a loss of signal, inadequate sequence coverage, and a dramatic increase in the difficulty of data analysis. In this work, the dissociation of disulfide-linked peptide dimers produced by peptic digestion of the 80 kDa glycoprotein transferrin in the course of HDX MS experiments is carried out using electron capture dissociation (ECD). ECD results in efficient cleavage of the thiol–thiol bonds in the gas phase on the fast LC time scale and allows the deuterium content of the monomeric constituents of the peptide dimers to be measured individually. The measurements appear to be unaffected by hydrogen scrambling, even when high collisional energies are utilized. This technique will benefit HDX MS measurements for any protein that contains one or more disulfides and the potential gain in sequence coverage and spatial resolution would increase with disulfide bond number.
———

Hydrogen/deuterium exchange (HDX) with mass spectrometry (MS) detection has evolved in the past two decades into a powerful tool that is now used to decipher intimate details of processes as diverse as protein folding, recognition and binding, and enzyme catalysis.1,2 While initially being a tool that was used exclusively in fundamental studies, HDX MS is now becoming an indispensable part of the analytical arsenal in the biopharmaceutical sector, where it is utilized increasingly in all stages of protein drug development from discovery to quality control.35 Despite this progress, several areas remain where the application of HDX MS has met with only limited success. Disulfide-rich proteins constitute one such group, where characterization of higher-order structure and dynamics is particularly difficult, because of the suboptimal conditions used for reduction of thiol–thiol bonds following a quench of the exchange reactions. Proteins containing disulfide bonds are encountered very rarely in the protein folding studies where the most popular targets are small proteins lacking cysteine residues (with a notable exception of the oxidative folding studies), as well as in many other fundamental studies focusing on proteins of prokaryotic origin. However, disulfide-rich proteins are encountered very frequently in eukaryotic proteomes6 and constitute a large segment of the biopharmaceutical products,7 where the thiol–thiol bonds are critical elements defining conformation of protein drugs, and also play an important role in stabilizing proteins by endowing them with protease resistance.

While disulfide bond reduction is a relatively trivial task that can be readily accomplished at neutral pH using a variety of reagents, the acidic, low-temperature environment where proteins are placed to quench HDX narrows down the choice to a single reducing agent, TCEP.8 However, the alkaline pH for optimal disulfide reduction by TCEP is substantially higher, compared to the acidic environment of typical “slow exchange conditions” commonly employed to minimize back exchange within proteins and their peptic fragments prior to MS analysis.9 Furthermore, disulfide reduction in HDX MS measurements is usually carried out within a relatively short period of time (a few minutes) and at low temperature (0–4 °C) to limit the extent of the back-exchange, which in many situations does not allow the complete dissociation of thiol–thiol linkages of individual peptic fragments to be achieved in solution prior to LC separation and MS analysis of their deuterium content. Incomplete reduction of disulfide bonds dramatically increases the pool of candidate peptides that should be considered when analyzing proteolytic fragments in HDX MS measurements and frequently reduces sequence coverage and/or spatial resolution. While the former problem can be solved by employing more powerful and robust search engines for peptide identification, the latter one is more difficult to circumvent and can be very detrimental for the quality of HDX MS data and may require significant changes in experimental protocols. Indeed, a complete failure to reduce a certain disulfide bond in a protein will give rise to a thiol–thiol linked peptide dimer, whose constituent monomers do not necessarily represent a contiguous segment of the protein and may have vastly different conformational and dynamic properties. The total deuterium content of the entire dimer (measured by HDX MS) would not provide any meaningful information under these conditions, thereby effectively reducing the sequence coverage in the corresponding segments of the protein.
———-

Disulfide-rich proteins have traditionally been challenging targets for HDX MS studies, because of incomplete reduction of thiol–thiol linkages, which is a consequence of the quench conditions used to minimize amide back-exchange in peptides prior to MS analysis of their deuterium content: limited time, low temperature, and low pH. Traditionally, the principal strategy to address difficult-to-reduce or high-density disulfides in the HDX MS workflow is a brute force approach utilizing high concentrations of reductant and denaturant prior to (or even in combination with) digestion. The effectiveness of this approach is protein-dependent and extended incubation times frequently employed to enhance exposure to reductant invariably result in an undesirable increase in H/D back exchange. More recently, a novel electrochemical approach to reduce disulfides in solution under quench conditions prior to LC-MS has been reported for insulin.32 While electrochemical reduction shows promise, several limitations were identified, an apparent requirement for low-salt conditions, a higher-than-optimal temperature (10 °C), and a current cell pressure limit of 50 bar. In this work, electron capture dissociation (ECD) was used to circumvent the disulfide problem, since it effectively cleaves external disulfide bonds. Dissociation of the disulfide-linked peptide dimers can be accomplished on the fast LC time scale and produces abundant signals for monomeric subunits without interchain hydrogen scrambling, even when collisional activation of ions is applied prior to ion selection and ECD fragmentation. Inclusion of ECD in the HDX MS workflow results in increased sequence coverage and spatial resolution and provides an attractive alternative to extensive chemical reduction of disulfide-rich proteins.

see more at   http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4051250/

Approach to Characterization of the Higher Order Structure of Disulfide-Containing Proteins Using Hydrogen/Deuterium Exchange and Top-Down Mass Spectrometry

Guanbo Wang† and Igor A. Kaltashov*
http://www.chem.umass.edu/people/kaltashovlab/papers/Approach.pdf

Top-down hydrogen/deuterium exchange (HDX) with mass spectrometric (MS) detection has recently matured to become a potent biophysical tool capable of providing valuable information on higher order structure and conformational dynamics of proteins at an unprecedented level of structural detail. However, the scope of the proteins amenable to the analysis by top-down HDX MS still remains limited, with the protein size and the presence of disulfide bonds being the two most important limiting factors. While the limitations imposed by the physical size of the proteins gradually become more relaxed as the sensitivity, resolution and dynamic range of modern MS instrumentation continue to improve at an ever accelerating pace, the presence of the disulfide linkages remains a much less forgiving limitation even for the proteins of relatively modest size. To circumvent this problem, we introduce an online chemical reduction step following completion and quenching of the HDX reactions and prior to the top-down MS measurements of deuterium occupancy of individual backbone amides. Application of the new methodology to the top-down HDX MS characterization of a small (99 residue long) disulfide-containing protein β2- microglobulin allowed the backbone amide protection to be probed with nearly a single-residue resolution across the entire sequence. The high-resolution backbone protection pattern deduced from the top-down HDX MS measurements carried out under native conditions is in excellent agreement with the crystal structure of the protein and high-resolution NMR data, suggesting that introduction of the chemical reduction step to the top-down routine does not trigger hydrogen scrambling either during the electrospray ionization process or in the gas phase prior to the protein ion dissociation.

Since its initial introduction in the late 1990s,1−3 top-down hydrogen/deuterium exchange (HDX) with mass spectrometric (MS) detection evolved to become a potent biophysical tool capable of providing valuable information on higher order structure and conformational dynamics of proteins at an unprecedented level of structural detail. Among the many advantages offered by top-down HDX MS compared to conventional (bottom-up) measurements are significant reduction or indeed complete elimination of the back exchange,4 high spatial resolution,5,6 and the ability to study conformational dynamics in the conformer-specific fashion.7,8 However, despite the spectacular recent advances and the broader acceptance of this technique, the scope of the proteins amenable to the analysis by top-down HDX MS remains limited, with the protein size and the presence of disulfide bonds being the two most important limiting factors. The limitations imposed by the physical size of the proteins gradually become more relaxed as the sensitivity, resolution, and dynamic range of modern MS instrumentation continue to improve at an ever accelerating pace. However, the presence of disulfides remains a much less forgiving limitation even for the proteins of relatively modest size.

In this work we demonstrated feasibility of applying top-down HDX MS measurements to characterize higher order structure and conformational dynamics of disulfide-containing proteins, which have been out of the reach of this technique so far. Use of a moderate amount of a reducing agent TCEP is compatible with the ESI process, while allowing a fraction of the protein molecules to be reduced in solution thereby enabling nearcomplete sequence coverage at high resolution. The agreement between the top-down HDX MS and NMR data sets demonstrate that the new experimental approach is capable of capturing the dynamic picture of protein conformation at high spatial resolution without compromising the quality of the data by triggering hydrogen scrambling in the gas phase. Despite its modest size, β2m is known to be able to populate a non-native state,35 which might be a key player in a variety of processes, including amyloidosis. However, the structure of this non-native state of β2m remains elusive since this conformer exists in dynamic equilibrium with the native state of the protein.36,37 Recently we demonstrated that top-down HDX MS provides an elegant way to selectively probe structure of protein states coexisting in solution at equilibrium;8 however, β2m remained out of reach of this technique until recently due to the presence of a disulfide bond. The ability to expand the scope of top-down HDX MS to disulfide-containing proteins opens up a host of exciting possibilities to explore the structure of β2m, interferon, lysozyme, and a variety of other disulfidecontaining proteins in a conformer-specific fashion, where physiologically important non-native states may play important roles in processes as diverse as folding, recognition, signaling, and amyloidosis. ■ ASSOCIATED CONTENT *S Supporting Information Representative examples of isotopic distributions of fragment ions that have (Supplementary Figure 1) and have not (Supplementary Figure 2) been used to calculate the deuterium occupancy at individual backbone amides of β2m in top-down HDX MS measurements. This material is available free of charge via the Internet at http://pubs.acs.org.

Determining surface topology of protein complexes

http://www.the-scientist.com/November2015/MS-surface-topology.jpg

SUSSING OUT THE SURFACE: Protein topology can be probed by firing low-energy electrons (white circles) at intact protein complexes within a high-resolution mass spectrometer. That reaction, called electron capture dissociation, causes the protein complex to fracture on its surface, revealing the exposed amino acid residues.     COURTESY OF PIRIYA WONGKONGKATHEP AND HUILIN LI, UCLA

RESEARCHER: Joseph Loo, Professor of Biological Chemistry, David Geffen School of Medicine, University of California, Los Angeles)

PROJECT: Studying protein-ligand and protein-protein interactions

SOLUTION: Loo is less interested in complex identification than in how the protein subunits assemble. Specifically, he wants to know which amino acid residues lie on the complex’s surface and which are buried inside or interacting with ligands.

It’s a question of structural biology, he explains: “How is this thing folded in a way that these residues are on the outside?”

To work that out, Loo combines high-resolution Fourier transform ion cyclotron resonance mass spectrometry (FTICR) with electron-capture dissociation (ECD), a mass spec fragmentation method in which an ion in the mass spectrometer interacts with free electrons, causing the protein to fracture along its peptide backbone. By measuring the mass of those fragments with high precision, researchers can determine the protein’s amino acid sequence.

In Loo’s case, though, that fragmentation is not uniform along the length of the protein. Proteins usually are denatured for mass spectrometry analysis, but the protein complexes in his studies are intact—a process called native mass spectrometry. Fragmentation thus occurs preferentially on the surface of the complex, like the cracks in the shell of a hard-boiled egg. “You get limited sequence information, but that sequence information comes from regions that are specific to its 3-D structure,” he says (Anal Chem, 86:317-20, 2014).

Native Top-Down ESI-MS of 158 kDa Protein Complex by High Resolution Fourier Transform Ion Cyclotron Resonance Mass Spectrometry

Fourier transform ion cyclotron resonance mass spectrometry (FT-ICR MS) delivers high resolving power, mass measurement accuracy, and the capabilities for unambiguously sequencing by a top-down MS approach. Here, we report isotopic resolution of a 158 kDa protein complex – tetrameric aldolase with an average absolute deviation of 0.36 ppm and an average resolving power of ~520,000 at m/z 6033 for the 26+ charge state in magnitude mode. Phase correction further improves the resolving power and average absolute deviation by 1.3 fold. Furthermore, native top-down electron capture dissociation (ECD) enables the sequencing of 149 C-terminal amino acid (AA) residues out of 463 total AAs. Combining the data from top-down MS of native and denatured aldolase complexes, a total of 58% of the backbone cleavages efficiency is achieved. The observation of complementary product ion pairs confirms the correctness of the sequence and also the accuracy of the mass fitting of the isotopic distribution of the aldolase tetramer. Top-down MS of the native protein provides complementary sequence information to top-down ECD and CAD MS of the denatured protein. Moreover, native top-down ECD of aldolase tetramer reveals that ECD fragmentation is not limited only to the flexible regions of protein complexes and that regions located on the surface topology are prone to ECD cleavage.

“Native” mass spectrometry (MS) is an emerging technique that has been successfully used to characterize intact, noncovalently-bound protein complexes, providing stoichiometry and structural information that is complementary to data supplied by conventional structural biology techniques.13 To confidently characterize protein complexes, electrospray ionization (ESI)-MS measurements acquired with isotopic resolving power (RP) and high mass accuracy and capabilities for deriving primary structure, i.e., sequence, information would be ideal. Fourier transform ion cyclotron resonance mass spectrometry (FT-ICR MS) is prominent for its superior resolving power and mass accuracy and its utility for tandem MS (MS/MS) with a variety of fragmentation techniques; FT-ICR MS is noted for characterizating posttranslational modifications (PTMs) and protein-ligand and protein-protein interactions.49 However, it remains challenging to isotopically resolving large biomolecules over 100 kDa due to sample heterogeneity, cation/solvent/buffer addition, space charge effects, and electric and magnetic field inhomogeneity (for FT-ICR).1013 Unit mass resolution has been achieved for a few denatured proteins, including a 112 kDa protein with 3 Da mass error using a 9.4 T FT-ICR MS,14 a 115 kDa protein by a 7 T instrument with a mass error of 5 ppm,4 and a 148 kDa protein with a mass error of 1 Da by a 9.4 T FTMS.10

Compared to denatured proteins, it is more difficult to achieve isotopic resolution for inherently lower charged (and thus, higher m/z) native protein complexes because (1) the peak height is proportional to its charge state, (2) the resolving power is inversely proportional to mass-to-charge ratio for FT-ICR MS, and (3) the broader isotope distribution of large biomolecules reduces overall signal-to-noise ratio.15 However, the introduction of a new FT-ICR analyzer cell – the ParaCell, by Nikolaev and coworkers has significantly increased the resolving power of FT-ICR MS.16, 17 By dynamically harmonizing the electric field potential at any radius of cyclotron motion in the entire cell volume, a resolving power of 39 M has been achieved for the alkaloid, resperine (m/z 609), using a 7 T system.18 In addition, a few native protein complexes, including enolase dimer (93 kDa, RP ~ 800,000 at m/z 4250), alcohol dehydrogenase tetramer (147 kDa, RP ~ 500,000 at m/z 5465), and enolase tetramer (186 kDa), have been isotopically resolved with a 12 T FT-ICR system with the new ICR cell.18 Although Mitchell and Smith reported that cyclotron phase locking due to Coulombic interactions limits the highest mass that unit mass resolution can be achieved by FT-ICR MS (Mmax ≈ 1×104B, where B is magnetic field strength),19 the ParaCell has made it significantly easier and promising to measure high resolution mass spectra for large native protein complexes.

……

Native top-down CAD and ISD were performed for the aldolase tetramer; dissociation of the tetramer to yield monomer was observed in both approaches and no sequence information was obtained. The cleavage sites from ECD (colored in red) and CAD (colored in green) of the denatured aldolase monomer (26+) are overlaid with the native ECD results for aldolase tetramer (Figure 2B). As shown in Figure 2B, in contrast to the limited number of c-ion fragments observed in the ECD of aldolase tetramer, ECD of denatured aldolase monomer induces extensive c-ion fragments in the N-terminal region and enables the assignment of first 156 N-terminal AA residues. Surprisingly, the number of z-ions observed from ECD of the denatured aldolase monomer is much less compared to the ECD of the native aldolase tetramer. Although it may be possible that the z-ions may undergo secondary fragmentation due to excess available energy, electrons, or long ion-electron reaction times during the ECD experiment, ECD experiments with reduced reaction time and bias voltages were performed and the results argue against this assumption. Overall, 58% of the total number of backbone bonds are cleaved from combining top-down MS of native aldolase complex and denatured aldolase monomer (20% for native ECD of aldolase tetramer, 37% for ECD of denatured aldolase, and 5% for CAD of denatured aldolase).

The three dimensional structure of the aldolase tetramer is shown in Figure 3. To compare the flexibility of the structure to the data from ECD of the aldolase tetramer, one of the subunits (B-chain) is presented as B-factor putty and the D-chain is shown with its native ECD backbone cleavage regions colored in red. The remaining A- and C-chains are shown in grey. Although the C-terminal region (AA 340–363) of each subunit is highly flexible based on the crystallography B-factor (see B-chain in Figure 3A), only 4 out of 75 backbone cleavage sites are from the AA 340–363 region. Instead, the native ECD fragments largely originate from surface regions of the protein structure (see D-chain in Figure 3A). The N-terminal regions are not directly involved in the interfaces between subunits, but they are located in regions that are partially buried, which is consistent with the limited c-ions observed. To better show the native ECD backbone cleavage regions, the D-chain is rotated 90 degrees clockwise (Figure 3B). It is clear that, although protein structure flexibility might play a role in the native top-down ECD fragmentation pattern, for aldolase the ECD cleavage sites are not limited to the flexible region. In addition, backbone cleavage regions from CAD (yellow) and ECD (cyan) of denatured aldolase are complementary with the native ECD results.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3908771/bin/nihms548404f3.jpg

A) Structure of tetrameric aldolase (1ZAH)29. A- and C-chains are shown as grey ribbons, the B-chain is shown in B-factor putty, and the D-chain is in cartoon with native ECD cleavage sites colored in red, CAD cleavage sites of denatured aldolase in yellow, and ECD cleavage sites of the N-terminal region from ECD of denatured aldolase in cyan. B) The D-chain is rotated 90 degrees clockwise to show the outer surface region of the subunit structure.

Also evident in such data sets are protein–small molecule interactions. As the proteins break apart, Loo explains, ligands often remain attached to the polypeptide shards that are produced. In one recent publication, for instance, his team mapped zinc binding sites in eukaryotic alcohol dehydrogenase, a 147-kDa tetrameric complex (J Am Soc Mass Spectrom, 25:2060-8, 2014).

Revealing Ligand Binding Sites and Quantifying Subunit Variants of Non-Covalent Protein Complexes in a Single Native Top-Down FTICR MS Experiment

“Native” mass spectrometry (MS) has been proven increasingly useful for structural biology studies of macromolecular assemblies. Using horse liver alcohol dehydrogenase (hADH) and yeast alcohol dehydrogenase (yADH) as examples, we demonstrate that rich information can be obtained in a single native top-down MS experiment using Fourier transform ion cyclotron mass spectrometry (FTICR MS). Beyond measuring the molecular weights of the protein complexes, isotopic mass resolution was achieved for yeast ADH tetramer (147 kDa) with an average resolving power of 412,700 at m/z 5466 in absorption mode and the mass reflects that each subunit binds to two zinc atoms. The N-terminal 89 amino acid residues were sequenced in a top-down electron capture dissociation (ECD) experiment, along with the identifications of the zinc binding site at Cys46 and a point mutation (V58T). With the combination of various activation/dissociation techniques, including ECD, in-source dissociation (ISD), collisionally activated dissociation (CAD), and infrared multiphoton dissociation (IRMPD), 40% of the yADH sequence was derived directly from the native tetramer complex. For hADH, native top-down ECD-MS shows that both E and S subunits are present in the hADH sample, with a relative ratio of 4:1. Native top-down ISD MS hADH dimer shows that each subunit (E and S chain) binds not only to two zinc atoms, but also the NAD+/NADH ligand, with a higher NAD+/NADH binding preference for the S chain relative to the E chain. In total, 32% sequence coverage was achieved for both E and S chains.

Studying how proteins interact with one another and assemble on a structural basis is key to understanding biological processes and their function. As a complementary technique to conventional technologies used in structural biology, such as nuclear magnetic resonance (NMR) spectroscopy, X-ray crystallography, and electron microscopy, “native” mass spectrometry (MS) has established its crucial role in the characterization of intact noncovalently-bound protein complexes, revealing the composition, stoichiometry, dynamics, stability, and also spatial information of subunit arrangements in protein assemblies [111]. To date, most native MS studies of protein complexes have been performed using quadrupole time-of-flight (Q-TOF) MS instruments with electrospray ionization (ESI). Because of the efficient transmission of high mass and highm/z ions using TOF analyzers, large proteins with molecular weights up to 18 MDa have been studied [12,13]. The coupling of ion mobility spectrometry (IMS) with mass spectrometry provides a new dimension to the analysis of biomolecules [14]. With IMS, ions are separated based on size and shape, and the IMS-derived collision cross-section information can be used to understand the topological properties of gas phase protein complexes. Surface induced dissociation (SID) has been recently added for the purposes of disassembling protein complexes into sub-complexes that appear to better reflect the structure of the solution phase complexes [1517]. The capability of Orbitrap MS has been extended significantly for the analysis of macromolecules, with greatly improved mass (and m/z) range and resolving power to measure the binding of ADP and ATP to the 800 kDa GroEL complex [18].

Fourier transform ion cyclotron resonance mass spectrometry (FTICR MS) is known for its superior resolving power and mass accuracy and its capabilities for tandem MS (MS/MS) with a variety of fragmentation techniques. Particularly, after the introduction of electron capture dissociation (ECD) [19], FTICR MS quickly established its utility for protein top-down protein sequencing, post-translational modification characterization, and protein gas phase studies [2034]. Polypeptide backbone bonds are cleaved by ECD, but non-covalent interactions are preserved, which therefore makes the native top-down MS study of the non-covalent interaction sites of protein-ligands complexes more feasible. Our group and others have successfully applied top-down ECD-MS to pinpoint the interaction sites of several protein-ligand system [3538], and this can be enhanced by “supercharging” [35]. An early attempt of applying ECD-MS to the study of large protein complexes was made by Heeren and Heck, but little topology and sequence information was derived [39]. However, the Gross group starting in 2010 made the first breakthrough for the study of large protein complexes using native top-down ECD with FTICR MS. Besides obtaining molecular weight, sequence, and metal-binding site information in a single MS experiment, they correlated the origins of ECD product ions to the flexible regions of proteins as determined by the “B-factor” from the X-ray crystal structures of protein complexes [40, 41]. Therefore, native top-down ECD has been proposed as a tool to probe the flexible regions of protein complexes. Our group recently also demonstrated the capability of obtaining sequence information and isotopic mass resolution of a noncovalently-bound protein complex of 158 kDa using native top-down FTICR MS, and most importantly, we found that the origin of ECD fragments is not limited only to the flexible region of the protein complex (e.g., tetrameric aldolase), but also largely from the surface of the complex [42].

The application of FTICR MS for native top-down interrogation of large non-covalent bound protein complexes is still in its infancy. Here, for the purpose of further exploring the capability of FTICR MS in the analysis of large protein complexes, various fragmentation techniques including in-source dissociation (ISD), collisionally activated dissociation (CAD), ECD, and infrared multiphoton dissociation (IRMPD) were applied in the native top-down MS studies of a 80 kDa dimeric protein complex and a 147 kDa tetrameric protein complex. The results demonstrate that with the superior resolving power, mass accuracy, and versatile fragmentation techniques of FTICR MS, rich information, including isotopic mass resolution, amino acid sequence, point mutations, metal/ligand binding sites, and identification and quantification of subunit variants can be accomplished in a single native top-down FTICR MS experiment.

see more at   http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4444062/

Still, Loo admits, the technique “is not really ready for prime time.” His team is collecting ECD data on a bank of proteins of known structure to ensure the data they collect really do reflect protein topology. In the meantime, they are working to extend the size of the complexes they can analyze. The technique’s current limit is 800 kDa.

GO NATIONAL: FTICR mass spectrometers offer top-of-the-line accuracy and resolution, with price tags to match. Few researchers have direct access to them, Loo says, but they can always try the national laboratories. Both the National High Magnetic Field Laboratory at Florida State University and the Environmental Molecular Sciences Laboratory at the Pacific Northwest National Laboratory have user facilities open to worthy projects.

Determining the architecture of protein complexes

RESEARCHER: Vicki Wysocki, Ohio Eminent Scholar and Professor of Chemistry and Biochemistry, Ohio State University

PROJECT: Instrumentation development for whole-complex analysis

SOLUTION: An analytical chemist by training, Wysocki focuses on instrumentation development for protein-complex analysis. Among the discoveries in her lab is a method called surface-induced dissociation (SID).

http://www.the-scientist.com/November2015/LT1_last.jpg

HIT THE WALL, JACK: When it comes to molecular collision in a mass spectrometer, size matters. Collide a complex with small gas molecules, and proteins in the complex will simply unravel (top). By smacking them into a “wall”—a process called surface-induced dissociation—the complex dissociates to reveal its underlying architecture.  COURTESY OF VICKI WYSOCKI

Like many other fragmentation approaches, SID works by forcing an ion in the mass spectrometer to collide with another object. Usually that object is a small gas molecule, with the energy of collision sufficient to crack the peptide backbone. But for large protein complexes, bigger is better, and the collision partner in SID is as big as it can get: the method slams protein ions of interest into a nonreactive surface inside the instrument—essentially, a wall—causing complexes to fracture into subcomplexes that reveal the assembly’s inner architecture.

Wysocki combined this approach with ion-mobility separation—a kind of gas-phase electrophoresis that resolves molecules by their size and shape—to dissect an enzyme involved in antibiotic production. The enzyme, they found, has two copies each of three subunits, alpha, beta, and gamma, arranged as a pair of triads sitting on top of one another, with the alpha and beta subunits of one triad linked more tightly to each other than either is to gamma (Anal Chem, 83:2862-65, 2011).

Such information can be valuable to protein engineers, Wysocki says, especially as this particular complex otherwise falls into a structural biology knowledge gap: “It doesn’t crystallize, and it’s too small for the cryoEM and a little bit large for NMR,” she says. “And so, mass spec turned out to be a great tool.”

Revealing the Quaternary Structure of a Heterogeneous Noncovalent Protein Complex through Surface-Induced Dissociation

Anne E. Blackwell, Eric D. Dodds,† Vahe Bandarian, and Vicki H. Wysocki*
https://research.cbc.osu.edu/wysocki.11/wp-content/uploads/2012/09/Blackwell-2011-Revealing-the-Quater.pdf

As scientists begin to appreciate the extent to which quaternary structure facilitates protein function, determination of the subunit arrangement within noncovalent protein complexes is increasingly important. While native mass spectrometry shows promise for the study of noncovalent complexes, few developments have been made toward the determination of subunit architecture, and no mass spectrometry activation method yields complete topology information. Here, we illustrate the surface-induced dissociation of a heterohexamer, toyocamycin nitrile hydratase, directly into its constituent trimers. We propose that the single-step nature of this activation in combination with high energy deposition allows for dissociation prior to significant unfolding or other large-scale rearrangement. This method can potentially allow for dissociation of a protein complex into subcomplexes, facilitating the mapping of subunit contacts and thus determination of quaternary structure of protein complexes.

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http://pubs.acs.org/appl/literatum/publisher/achs/journals/content/ancham/2011/ancham.2011.83.issue-8/ac200452b/production/pdfimages_v02/normal.img-000.jpg

The majority of proteins exist and perform their functions as multimers of varing stoichiometries and architecture.1 However, very few methods are available that can provide insights into subunit interactions. Native mass spectrometry (MS) is increasingly being used to study noncovalent protein complexes, as many structural features found in solution may be maintained in the gas phase.2,3 While subunit stoichiometries are readily obtainable by mass measurement alone, the determination of subunit arrangement within protein complexes remains a significant challenge. This is particularly true for heterogeneous complexes with multiple types of subunits. Considerable progress has been made using solution-phase disruption to divide the original protein complex into smaller subcomplexes, which may be readily measured by MS.4,5 The composition of the stable subcomplexes provides insight on the topology of the protein complex. However, MS activation methods used to date have fallen short of providing subunit topology. Here, we present the first evidence for subunit arrangement obtained directly from gas-phase experiments on a heterogeneous complex via surfaceinduced dissociation (SID). We have demonstrated previously the ability of SID to yield unique dissociation pathways for protein complexes, resulting in complementary information to collision-induced dissociation (CID).68 While the SID process is not yet well understood for macromolecules, there is a large body of work concerning SID of small molecules; influential factors such as collision energy, surface composition, and translational-to-vibrational energy conversion have been well-studied.911 The higher effective mass of a surface relative to that of neutral gas atoms used in CID (typically argon) results in significantly higher energy deposited through a single surface collision.9 As SID is a single-collision activation process, rather than activation via thousands of less energetic collisions as in CID, dissociation pathways other than those of the lowest energies become accessible

……

This is the only study to date demonstrating an ion activation method capable of yielding extensive dissociation, as well as the release of intact subcomplexes, thus providing relevant substructure information on a noncovalent, hetero-oligomeric protein complex. The capacity to produce intact, charge-symmetric subcomplexes suggests that dissociation occurs faster than subunit unfolding and that a significant degree of secondary and tertiary structure is maintained up to the point of dissociation and for some period of time afterward. Identification of trimeric substructure in TNH provides insight into a protein with little previous structural characterization and indicates a promising advancement of MS as a tool for structural biology.

Such information can be valuable to protein engineers, Wysocki says, especially as this particular complex otherwise falls into a structural biology knowledge gap: “It doesn’t crystallize, and it’s too small for the cryoEM and a little bit large for NMR,” she says. “And so, mass spec turned out to be a great tool.”

CHOOSE MASS: Mass spec may not be the only method for quickly working out protein structure, but it surely is the fastest, Wysocki says. She recalls one instance when a colleague sent over a complex that his group couldn’t crack. “In one afternoon, my student gave them a prediction of the structure: this one’s a heptamer, with a large subunit sitting atop a hexameric ring.” Even if the experiment doesn’t work, she adds, that fast turnaround time can be a boon, as collaborators can get rapid feedback for tweaking their experimental conditions. “Mass is a great thing.”

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Irreconciliable Dissonance in Physical Space and Cellular Metabolic Conception

Irreconciliable Dissonance in Physical Space and Cellular Metabolic Conception

Curator: Larry H. Bernstein, MD, FCAP

Pasteur Effect – Warburg Effect – What its history can teach us today. 

José Eduardo de Salles Roselino

The Warburg effect, in reality the “Pasteur-effect” was the first example of metabolic regulation described. A decrease in the carbon flux originated at the sugar molecule towards the end of the catabolic pathway, with ethanol and carbon dioxide observed when yeast cells were transferred from an anaerobic environmental condition to an aerobic one. In Pasteur´s studies, sugar metabolism was measured mainly by the decrease of sugar concentration in the yeast growth media observed after a measured period of time. The decrease of the sugar concentration in the media occurs at great speed in yeast grown in anaerobiosis (oxygen deficient) and its speed was greatly reduced by the transfer of the yeast culture to an aerobic condition. This finding was very important for the wine industry of France in Pasteur’s time, since most of the undesirable outcomes in the industrial use of yeast were perceived when yeasts cells took a very long time to create, a rather selective anaerobic condition. This selective culture media was characterized by the higher carbon dioxide levels produced by fast growing yeast cells and by a higher alcohol content in the yeast culture media.

However, in biochemical terms, this finding was required to understand Lavoisier’s results indicating that chemical and biological oxidation of sugars produced the same calorimetric (heat generation) results. This observation requires a control mechanism (metabolic regulation) to avoid burning living cells by fast heat released by the sugar biological oxidative processes (metabolism). In addition, Lavoisier´s results were the first indications that both processes happened inside similar thermodynamics limits. In much resumed form, these observations indicate the major reasons that led Warburg to test failure in control mechanisms in cancer cells in comparison with the ones observed in normal cells.

[It might be added that the availability of O2 and CO2 and climatic conditions over 750 million years that included volcanic activity, tectonic movements of the earth crust, and glaciation, and more recently the use of carbon fuels and the extensive deforestation of our land masses have had a large role in determining the biological speciation over time, in sea and on land. O2 is generated by plants utilizing energy from the sun and conversion of CO2. Remove the plants and we tip the balance. A large source of CO2 is from beneath the earth’s surface.]

Biology inside classical thermodynamics places some challenges to scientists. For instance, all classical thermodynamics must be measured in reversible thermodynamic conditions. In an isolated system, increase in P (pressure) leads to increase in V (volume), all this occurring in a condition in which infinitesimal changes in one affects in the same way the other, a continuum response. Not even a quantic amount of energy will stand beyond those parameters.

In a reversible system, a decrease in V, under same condition, will led to an increase in P. In biochemistry, reversible usually indicates a reaction that easily goes either from A to B or B to A. For instance, when it was required to search for an anti-ischemic effect of Chlorpromazine in an extra hepatic obstructed liver, it was necessary to use an adequate system of increased biliary system pressure in a reversible manner to exclude a direct effect of this drug over the biological system pressure inducer (bile secretion) in Braz. J. Med. Biol. Res 1989; 22: 889-893. Frequently, these details are jumped over by those who read biology in ATGC letters.

Very important observations can be made in this regard, when neutral mutations are taken into consideration since, after several mutations (not affecting previous activity and function), a last mutant may provide a new transcript RNA for a protein and elicit a new function. For an example, consider a Prion C from lamb getting similar to bovine Prion C while preserving  its normal role in the lamb when its ability to change Human Prion C is considered (Stanley Prusiner).

This observation is good enough, to confirm one of the most important contributions of Erwin Schrodinger in his What is Life:

“This little book arose from a course of public lectures, delivered by a theoretical physicist to an audience of about four hundred which did not substantially dwindle, though warned at the outset that the subject matter was a difficult one and that the lectures could not be termed popular, even though the physicist’s most dreaded weapon, mathematical deduction, would hardly be utilized. The reason for this was not that the subject was simple enough to be explained without mathematics, but rather that it was much too involved to be fully accessible to mathematics.”

After Hans Krebs, description of the cyclic nature of the citrate metabolism and after its followers described its requirement for aerobic catabolism two major lines of research started the search for the understanding of the mechanism of energy transfer that explains how ADP is converted into ATP. One followed the organic chemistry line of reasoning and therefore, searched for a mechanism that could explain how the breakdown of carbon-carbon link could have its energy transferred to ATP synthesis. One of the major leaders of this research line was Britton Chance. He took into account that relatively earlier in the series of Krebs cycle reactions, two carbon atoms of acetyl were released as carbon dioxide ( In fact, not the real acetyl carbons but those on the opposite side of citrate molecule). In stoichiometric terms, it was not important whether the released carbons were or were not exactly those originated from glucose carbons. His research aimed at to find out an intermediate proteinaceous intermediary that could act as an energy reservoir. The intermediary could store in a phosphorylated amino acid the energy of carbon-carbon bond breakdown. This activated amino acid could transfer its phosphate group to ADP producing ATP. A key intermediate involved in the transfer was identified by Kaplan and Lipmann at John Hopkins as acetyl coenzyme A, for which Fritz Lipmann received a Nobel Prize.

Alternatively, under possible influence of the excellent results of Hodgkin and Huxley a second line of research appears. The work of Hodgkin & Huxley indicated that the storage of electrical potential energy in transmembrane ionic asymmetries and presented the explanation for the change from resting to action potential in excitable cells. This second line of research, under the leadership of Peter Mitchell postulated a mechanism for the transfer of oxide/reductive power of organic molecules oxidation through electron transfer as the key for the energetic transfer mechanism required for ATP synthesis.
This diverted the attention from high energy (~P) phosphate bond to the transfer of electrons. During most of the time the harsh period of the two confronting points of view, Paul Boyer and followers attempted to act as a conciliatory third party, without getting good results, according to personal accounts (in L. A. or Latin America) heard from those few of our scientists who were able to follow the major scientific events held in USA, and who could present to us later. Paul  Boyer could present how the energy was transduced by a molecular machine that changes in conformation in a series of 3 steps while rotating in one direction in order to produce ATP and in opposite direction in order to produce ADP plus Pi from ATP (reversibility).

However, earlier, a victorious Peter Mitchell obtained the result in the conceptual dispute, over the Britton Chance point of view, after he used E. Coli mutants to show H+ gradients in the cell membrane and its use as energy source, for which he received a Nobel Prize. Somehow, this outcome represents such a blow to Chance’s previous work that somehow it seems to have cast a shadow over very important findings obtained during his earlier career that should not be affected by one or another form of energy transfer mechanism.  For instance, Britton Chance got the simple and rapid polarographic assay method of oxidative phosphorylation and the idea of control of energy metabolism that brings us back to Pasteur.

This metabolic alternative result seems to have been neglected in the recent years of obesity epidemics, which led to a search for a single molecular mechanism required for the understanding of the accumulation of chemical (adipose tissue) reserve in our body. It does not mean that here the role of central nervous system is neglected. In short, in respiring mitochondria the rate of electron transport linked to the rate of ATP production is determined primarily by the relative concentrations of ADP, ATP and phosphate in the external media (cytosol) and not by the concentration of respiratory substrate as pyruvate. Therefore, when the yield of ATP is high as it is in aerobiosis and the cellular use of ATP is not changed, the oxidation of pyruvate and therefore of glycolysis is quickly (without change in gene expression), throttled down to the resting state. The dependence of respiratory rate on ADP concentration is also seen in intact cells. A muscle at rest and using no ATP has a very low respiratory rate.   [When skeletal muscle is stressed by high exertion, lactic acid produced is released into the circulation and is metabolized aerobically by the heart at the end of the activity].

This respiratory control of metabolism will lead to preservation of body carbon reserves and in case of high caloric intake in a diet, also shows increase in fat reserves essential for our biological ancestors survival (Today for our obesity epidemics). No matter how important this observation is, it is only one focal point of metabolic control. We cannot reduce the problem of obesity to the existence of metabolic control. There are numerous other factors but on the other hand, we cannot neglect or remove this vital process in order to correct obesity. However, we cannot explain obesity ignoring this metabolic control. This topic is so neglected in modern times that we cannot follow major research lines of the past that were interrupted by the emerging molecular biology techniques and the vain belief that a dogmatic vision of biology could replace all previous knowledge by a new one based upon ATGC readings. For instance, in order to display bad consequences derived from the ignorance of these old scientific facts, we can take into account, for instance, how ion movements across membranes affects membrane protein conformation and therefore contradicts the wrong central dogma of molecular biology. This change in protein conformation (with unchanged amino acid sequence) and/or the lack of change in protein conformation is linked to the factors that affect vital processes as the heart beats. This modern ignorance could also explain some major pitfalls seen in new drugs clinical trials and in a small scale on bad medical practices.

The work of Britton Chance and of Peter Mitchell have deep and sound scientific roots that were made with excellent scientific techniques, supported by excellent scientific reasoning and that were produced in a large series of very important intermediary scientific results. Their sole difference was to aim at very different scientific explanations as their goals (They have different Teleology in their minds made by their previous experiences). When, with the use of mutants obtained in microorganisms P Mitchell´s goal was found to survive and B Chance to succumb to the experimental evidence, all those excellent findings of B Chance and followers were directed to the dustbin of scientific history as an example of lack of scientific consideration.  [On the one hand, the Mitchell model used a unicellular organism; on the other, Chance’s work was with eukaryotic cells, quite relevant to the discussion.]

We can resume the challenge faced by these two great scientists in the following form: The first conceptual unification in bioenergetics, achieved in the 1940s, is inextricably bound up with the name of Fritz Lipmann. Its central feature was the recognition that adenosine triphosphate, ATP, serves as a universal energy  “currency” much as money serves as economic currency. In a nutshell, the purpose of metabolism is to support the synthesis of ATP. In microorganisms, this is perfect! In humans or mammals, or vertebrates, by the same reason that we cannot consider that gene expression is equivalent to protein function (an acceptable error in the case of microorganisms) this oversimplifies the metabolic requirement with a huge error. However, in case our concern is ATP chemistry only, the metabolism produces ATP and the hydrolysis of ATP pays for the performance of almost, all kinds of works. It is possible to presume that to find out how the flow of metabolism (carbon flow) led to ATP production must be considered a major focal point of research of the two contenders. Consequently, what could be a minor fall of one of the contenders, in case we take into account all that was found during their entire life of research, the real failure in B Chance’s final goal was amplified far beyond what may be considered by reason!

Another aspect that must be taken into account: Both contenders have in the scientific past a very sound root. Metabolism may produce two forms of energy currency (I personally don´t like this expression*) and I use it here because it was used by both groups in order to express their findings. Together with simplistic thermodynamics, this expression conveys wrong ideas): The second kind of energy currency is the current of ions passing from one side of a membrane to the other. The P. Mitchell scientific root undoubtedly have the work of Hodgkin & Huxley, Huxley &  Huxley, Huxley & Simmons

*ATP is produced under the guidance of cell needs and not by its yield. When glucose yields only 2 ATPs per molecule it is oxidized at very high speed (anaerobiosis) as is required to match cellular needs. On the other hand, when it may yield (thermodynamic terms) 38 ATP the same molecule is oxidized at low speed. It would be similar to an investor choice its least money yield form for its investment (1940s to 1972) as a solid support. B. Chance had the enzymologists involved in clarifying how ATP could be produced directly from NADH + H+ oxidative reductive metabolic reactions or from the hydrolysis of an enolpyruvate intermediary. Both competitors had their work supported by different but, sound scientific roots and have produced very important scientific results while trying to present their hypothetical point of view.

Before the winning results of P. Mitchell were displayed, one line of defense used by B. Chance followers was to create a conflict between what would be expected by a restrictive role of proteins through its specificity ionic interactions and the general ability of ionic asymmetries that could be associated with mitochondrial ATP production. Chemical catalyzed protein activities do not have perfect specificity but an outstanding degree of selective interaction was presented by the lock and key model of enzyme interaction. A large group of outstanding “mitochondriologists” were able to show ATP synthesis associated with Na+, K+, Ca2+… asymmetries on mitochondrial membranes and any time they did this, P. Mitchell have to display the existence of antiporters that exchange X for hydrogen as the final common source of chemiosmotic energy used by mitochondria for ATP synthesis.

This conceptual battle has generated an enormous knowledge that was laid to rest, somehow discontinued in the form of scientific research, when the final E. Coli mutant studies presented the convincing final evidence in favor of P. Mitchell point of view.

Not surprisingly, a “wise anonymous” later, pointed out: “No matter what you are doing, you will always be better off in case you have a mutant”

(Principles of Medical Genetics T D Gelehrter & F.S. Collins chapter 7, 1990).

However, let’s take the example of a mechanical wristwatch. It clearly indicates when the watch is working in an acceptable way, that its normal functioning condition is not the result of one of its isolated components – or something that can be shown by a reductionist molecular view.  Usually it will be considered that it is working in an acceptable way, in case it is found that its accuracy falls inside a normal functional range, for instance, one or two standard deviations bellow or above the mean value for normal function, what depends upon the rigor wisely adopted. While, only when it has a faulty component (a genetic inborn error) we can indicate a single isolated piece as the cause of its failure (a reductionist molecular view).

We need to teach in medicine, first the major reasons why the watch works fine (not saying it is “automatic”). The functions may cross the reversible to irreversible regulatory limit change, faster than what we can imagine. Latter, when these ideas about normal are held very clear in the mind set of medical doctors (not medical technicians) we may address the inborn errors and what we may have learn from it. A modern medical technician may cause admiration when he uses an “innocent” virus to correct for a faulty gene (a rather impressive technological advance). However, in case the virus, later shows signals that indicate that it was not so innocent, a real medical doctor will be called upon to put things in correct place again.

Among the missing parts of normal evolution in biochemistry a lot about ion fluxes can be found. Even those oscillatory changes in Ca2+ that were shown to affect gene expression (C. De Duve) were laid to rest since, they clearly indicate a source of biological information that despite the fact that it does not change nucleotides order in the DNA, it shows an opposing flux of biological information against the dogma (DNA to RNA to proteins). Another, line has shown a hierarchy, on the use of mitochondrial membrane potential: First the potential is used for Ca2+ uptake and only afterwards, the potential is used for ADP conversion into ATP (A. L. Lehninger). In fact, the real idea of A. L. Lehninger was by far, more complex since according to him, mitochondria works like a buffer for intracellular calcium releasing it to outside in case of a deep decrease in cytosol levels or capturing it from cytosol when facing transient increase in Ca2+ load. As some of Krebs cycle dehydrogenases were activated by Ca2+, this finding was used to propose a new control factor in addition to the one of ADP (B. Chance). All this was discontinued with the wrong use of calculus (today we could indicate bioinformatics in a similar role) in biochemistry that has established less importance to a mitochondrial role after comparative kinetics that today are seen as faulty.

It is important to combat dogmatic reasoning and restore sound scientific foundations in basic medical courses that must urgently reverse the faulty trend that tries to impose a view that goes from the detail towards generalization instead of the correct form that goes from the general finding well understood towards its molecular details. The view that led to curious subjects as bioinformatics in medical courses as training in sequence finding activities can only be explained by its commercial value. The usual form of scientific thinking respects the limits of our ability to grasp new knowledge and relies on reproducibility of scientific results as a form to surpass lack of mathematical equation that defines relationship of variables and the determination of its functional domains. It also uses old scientific roots, as its sound support never replaces existing knowledge by dogmatic and/or wishful thinking. When the sequence of DNA was found as a technical advance to find amino acid sequence in proteins it was just a technical advance. This technical advance by no means could be considered a scientific result presented as an indication that DNA sequences alone have replaced the need to study protein chemistry, its responses to microenvironmental changes in order to understand its multiple conformations, changes in activities and function. As E. Schrodinger correctly describes the chemical structure responsible for the coded form stored of genetic information must have minimal interaction with its microenvironment in order to endure hundreds and hundreds years as seen in Hapsburg’s lips. Only magical reasoning assumes that it is possible to find out in non-reactive chemical structures the properties of the reactive ones.

For instance, knowledge of the reactions of the Krebs cycle clearly indicate a role for solvent that no longer could be considered to be an inert bath for catalytic activity of the enzymes when the transfer of energy include a role for hydrogen transport. The great increase in understanding this change on chemical reaction arrived from conformational energy.

Again, even a rather simplistic view of this atomic property (Conformational energy) is enough to confirm once more, one of the most important contribution of E. Schrodinger in his What is Life:

“This little book arose from a course of public lectures, delivered by a theoretical physicist to an audience of about four hundred which did not substantially dwindle, though warned at the outset that the subject matter was a difficult one and that the lectures could not be termed popular, even though the physicist’s most dreaded weapon, mathematical deduction, would hardly be utilized. The reason for this was not that the subject was simple enough to be explained without mathematics, but rather that it was much too involved to be fully accessible to mathematics.”

In a very simplistic view, while energy manifests itself by the ability to perform work conformational energy as a property derived from our atomic structure can be neutral, positive or negative (no effect, increased or decreased reactivity upon any chemistry reactivity measured as work)

Also:

“I mean the fact that we, whose total being is entirely based on a marvelous interplay of this very kind, yet if all possess the power of acquiring considerable knowledge about it. I think it possible that this knowledge may advance to little just a short of a complete understanding -of the first marvel. The second may well be beyond human understanding.”

In fact, scientific knowledge allows us to understand how biological evolution may have occurred or have not occurred and yet does not present a proof about how it would have being occurred. It will be always be an indication of possible against highly unlike and never a scientific proven fact about the real form of its occurrence.

As was the case of B. Chance in its bioenergetics findings, we may get very important findings that indicates wrong directions in the future as was his case, or directed toward our past.

The Skeleton of Physical Time – Quantum Energies in Relative Space of S-labs

By Radoslav S. Bozov  Independent Researcher

WSEAS, Biology and BioSystems of Biomedicine

Space does not equate to distance, displacement of an object by classically defined forces – electromagnetic, gravity or inertia. In perceiving quantum open systems, a quanta, a package of energy, displaces properties of wave interference and statistical outcomes of sums of paths of particles detected by a design of S-labs.

The notion of S-labs, space labs, deals with inherent problems of operational module, R(i+1), where an imagination number ‘struggles’ to work under roots of a negative sign, a reflection of an observable set of sums reaching out of the limits of the human being organ, an eye or other foundational signal processing system.

While heavenly bodies, planets, star systems, and other exotic forms of light reflecting and/or emitting objects, observable via naked eye have been deduced to operate under numerical systems that calculate a periodic displacement of one relative to another, atomic clocks of nanospace open our eyes to ever expanding energy spaces, where matrices of interactive variables point to the problem of infinity of variations in scalar spaces, however, defining properties of minute universes as a mirror image of an astronomical system. The first and furthermost problem is essentially the same as those mathematical methodologies deduced by Isaac Newton and Albert Einstein for processing a surface. I will introduce you to a surface interference method by describing undetermined objective space in terms of determined subjective time.

Therefore, the moment will be an outcome of statistical sums of a numerical system extending from near zero to near one. Three strings hold down a dual system entangled via interference of two waves, where a single wave is a product of three particles (today named accordingly to either weak or strong interactions) momentum.

The above described system emerges from duality into trinity the objective space value of physical realities. The triangle of physical observables – charge, gravity and electromagnetism, is an outcome of interference of particles, strings and waves, where particles are not particles, or are strings strings, or  are waves waves of an infinite character in an open system which we attempt to define to predict outcomes of tomorrow’s parameters, either dependent or independent as well as both subjective to time simulations.

We now know that aging of a biological organism cannot be defined within singularity. Thereafter, clocks are subjective to apparatuses measuring oscillation of defined parameters which enable us to calculate both amplitude and a period, which we know to be dependent on phase transitions.

The problem of phase was solved by the applicability of carbon relative systems. A piece of diamond does not get wet, yet it holds water’s light entangled property. Water is the dark force of light. To formulate such statement, we have been searching truth by examining cooling objects where the Maxwell demon is translated into information, a data complex system.

Modern perspectives in computing quantum based matrices, 0+1 =1 and/or 0+0=1, and/or 1+1 =0, will be reduced by applying a conceptual frame of Aladdin’s flying anti-gravity carpet, unwrapping both past and future by sending a photon to both, placing present always near zero. Thus, each parallel quantum computation of a natural system approaching the limit of a vibration of a string defining 0 does not equal 0, and 1 does not equal 1. In any case, if our method 1+1 = 1, yet, 1 is not 1 at time i+1. This will set the fundamentals of an operational module, called labris operator or in simplicity S-labs. Note, that 1 as a result is an event predictable to future, while interacting parameters of addition 1+1 may be both, 1 as an observable past, and 1 as an imaginary system, or 1+1 displaced interactive parameters of past observable events. This is the foundation of Future Quantum Relative Systems Interference (QRSI), taking analytical technologies of future as a result of data matrices compressing principle relative to carbon as a reference matter rational to water based properties.

Goedel’s concept of loops exist therefore only upon discrete relative space uniting to parallel absolute continuity of time ‘lags’. ( Goedel, Escher and Bach: An Eternal Golden Braid. A Metaphorical Fugue on Minds and Machines in the Spirit of Lewis Carroll. D Hofstadter.  Chapter XX: Strange Loops, Or Tangled Hierarchies. A grand windup of many of the ideas about hierarchical systems and self-reference. It is concerned with the snarls which arise when systems turn back on themselves-for example, science probing science, government investigating governmental wrongdoing, art violating the rules of art, and finally, humans thinking about their own brains and minds. Does Gödel’s Theorem have anything to say about this last “snarl”? Are free will and the sensation of consciousness connected to Gödel’s Theorem? The Chapter ends by tying Gödel, Escher, and Bach together once again.)  The fight struggle in-between time creates dark spaces within which strings manage to obey light properties – entangled bozons of information carrying future outcomes of a systems processing consciousness. Therefore, Albert Einstein was correct in his quantum time realities by rejecting a resolving cube of sugar within a cup of tea (Henri Bergson 19th century philosopher. Bergson’s concept of multiplicity attempts to unify in a consistent way two contradictory features: heterogeneity and continuity. Many philosophers today think that this concept of multiplicity, despite its difficulty, is revolutionary.) However, the unity of time and space could not be achieved by deducing time to charge, gravity and electromagnetic properties of energy and mass.

Charge is further deduced to interference of particles/strings/waves, contrary to the Hawking idea of irreducibility of chemical energy carrying ‘units’, and gravity is accounted for by intrinsic properties of   anti-gravity carbon systems processing light, an electromagnetic force, that I have deduced towards ever expanding discrete energy space-energies rational to compressing mass/time. The role of loops seems to operate to control formalities where boundaries of space fluctuate as a result of what we called above – dark time-spaces.

Indeed, the concept of horizon is a constant due to ever expanding observables. Thus, it fails to acquire a rational approach towards space-time issues.

Richard Feynman has touched on issues of touching of space, sums of paths of particle traveling through time. In a way he has resolved an important paradigm, storing information and possibly studying it by opening a black box. Schroedinger’s cat is alive again, but incapable of climbing a tree when chased by a dog. Every time a cat climbs a garden tree, a fruit falls on hedgehogs carried away parallel to living wormholes whose purpose of generating information lies upon carbon units resolving light.

In order to deal with such a paradigm, we will introduce i+1 under square root in relativity, therefore taking negative one ( -1 = sqrt (i+1), an operational module R dealing with Wheelers foam squeezed by light, releasing water – dark spaces. Thousand words down!

What is a number? Is that a name or some kind of language or both? Is the issue of number theory possibly accountable to the value of the concept of entropic timing? Light penetrating a pyramid holding bean seeds on a piece of paper and a piece of slice of bread, a triple set, where a church mouse has taken a drop of tear, but a blood drop. What an amazing physics! The magic of biology lies above egoism, above pride, and below Saints.

We will set up the twelve parameters seen through 3+1 in classic realities:

–              discrete absolute energies/forces – no contradiction for now between Newtonian and Albert Einstein mechanics

–              mass absolute continuity – conservational law of physics in accordance to weak and strong forces

–              quantum relative spaces – issuing a paradox of Albert Einstein’s space-time resolved by the uncertainty principle

–              parallel continuity of multiple time/universes – resolving uncertainty of united space and energy through evolving statistical concepts of scalar relative space expansion and vector quantum energies by compressing relative continuity of matter in it, ever compressing flat surfaces – finding the inverse link between deterministic mechanics of displacement and imaginary space, where spheres fit within surface of triangles as time unwraps past by pulling strings from future.

To us, common human beings, with an extra curiosity overloaded by real dreams, value happens to play in the intricate foundation of life – the garden of love, its carbon management in mind, collecting pieces of squeezed cooling time.

The infinite interference of each operational module to another composing ever emerging time constrains unified by the Solar system, objective to humanity, perhaps answers that a drop of blood and a drop of tear is united by a droplet of a substance separating negative entropy to time courses of a physical realities as defined by an open algorithm where chasing power subdue to space becomes an issue of time.

Jose Eduardo de Salles Roselino

Some small errors: For intance an increase i P leads to a decrease in V ( not an increase in V)..

 

Radoslav S. Bozov  Independent Researcher

If we were to use a preventative measures of medical science, instruments of medical science must predict future outcomes based on observable parameters of history….. There are several key issues arising: 1. Despite pinning a difference on genomic scale , say pieces of information, we do not know how to have changed that – that is shift methylome occupying genome surfaces , in a precise manner.. 2. Living systems operational quo DO NOT work as by vector gravity physics of ‘building blocks. That is projecting a delusional concept of a masonry trick, who has not worked by corner stones and ever shifting momenta … Assuming genomic assembling worked, that is dealing with inferences through data mining and annotation, we are not in a position to read future in real time, and we will never be, because of the rtPCR technology self restriction into data -time processing .. We know of existing post translational modalities… 3. We don’t know what we don’t know, and that foundational to future medicine – that is dealing with biological clocks, behavior, and various daily life inputs ranging from radiation to water systems, food quality, drugs…

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Phase I/II Hepato-specific Glucokinase Activator

Larry H. Bernstein, MD, FCAP, Curator

LPBI

Advinus Therapeutics announced that it has successfully completed a 14-day POC study in 60 Type II diabetic patients on its lead molecule, GKM-001, a glucokinase activator. The results of the trial show effective glucose lowering across all doses tested without any incidence of hypoglycemia or any other clinically relevant adverse events.

GKM-001 is differentiated from most other GK molecules that are in development, or have been discontinued, due to its novel liver selective mechanism of action.

GKM-001 belongs to a novel class of molecules for treatment of type II diabetes. It is an activator of Glucokinase (GK), a glucose-sensing enzyme found mainly in the liver and pancreas. Being liver selective, GKM-001 mostly activates GK in the liver and not in pancreas, which is its key differentiation from most competitor molecules that activate GK in pancreas as well.

GKM 001 in pipeline for Diabetes by Advinus

by DR ANTHONY MELVIN CRASTO Ph.D

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GKM 001

Advinus Therapeutics Private L,

A glucokinase activator for treatment of type II diabetes, currently in PI. Advinus is actively exploring partnership options to expedite further development and WW marketing of GKM-001.

Company Advinus Therapeutics Ltd.
Description Activator of glucokinase (GCK; GK)
Molecular Target Glucokinase (GCK) (GK)
Mechanism of Action Glucokinase activator
Therapeutic Modality Small molecule
Latest Stage of Development Phase I/II
Standard Indication Diabetes
Indication Details Treat Type II diabetes

PATENT

https://www.google.co.in/patents/WO2009047798A2?cl=en

Example Cl : (-)-{5-ChIoro-2-[2-(4-cyclopropanesulfonylphenyI)-2-(2,4- difluorophenoxy)acetylamino]thiazol-4-yl}-acetic acid, ethyl ester
1H NMR(400 MHz, CDCl3): δ 1.06-1.08 (m, 2H), 1.30 (t, J=7.2 Hz, 3H), 1.33-1.38 (m, 2H), 2.42-2.50 (m, IH), 3.73 (d, J=2 Hz, 2H), 4.22 (q, J=7.2 Hz ,2H), 5.75 (s, IH), 6.76- 6.77 (m, IH), 6.83-6.86 (m, IH), 6.90-6.98 (m, IH), 7.73 (d, J=8.4 Hz, 2H), 7.96 (d, J=8.4 Hz, 2H), 9.96 (bs, IH). MS (EI) m/z: 571.1 and 573.1 (M+ 1; for 35Cl and 37Cl respectively).

Examples C2 and C3 were prepared in analogues manner of example (Cl) from the appropriate chiral intermediate:

Figure imgf000044_0002

Example Dl : (+)-{5-Chloro-2-[2-(4-cyclopropanesulfonylphenyl)-2-(2,4- difluorophenoxy)acetylamino]thiazol-4-yl}acetic acid, ethyl ester

Advinus’ GK-activator Achieves Early POC for Diabetes

November 29 2011

Partnership Dialog Actively Underway

Advinus Therapeutics, a research-based pharmaceutical company founded by globally experienced industry executives and promoted by the TATA Group, announced that it has successfully completed a 14-day POC study in 60 Type II diabetic patients on its lead molecule, GKM-001, a glucokinase activator. The results of the trial show effective glucose lowering across all doses tested without any incidence of hypoglycemia or any other clinically relevant adverse events.

The clinical trials on GKM-001 validate the company’s pre-clinical hypothesis that a liver selective Glucokinase activator would not cause hypoglycemia (very low blood sugar), while showing robust efficacy.

“GKM-001 is differentiated from most other GK molecules that are in development, or have been discontinued, due to its novel liver selective mechanism of action. GKM-001 has a prolonged pharmacological effect and a half-life that should support a once a day dosing as both mono and combination therapy.” said Dr. Rashmi Barbhaiya, MD & CEO, Advinus Therapeutics. He added that Advinus is actively exploring partnership options to expedite further development and global marketing of GKM-001.

GKM-001 belongs to a novel class of molecules for treatment of type II diabetes. It is an activator of Glucokinase (GK), a glucose-sensing enzyme found mainly in the liver and pancreas. Being liver selective, GKM-001 mostly activates GK in the liver and not in pancreas, which is its key differentiation from most competitor molecules that activate GK in pancreas as well. The resulting increase in insulin secretion creates a potential for hypoglycemia-a risk GKM-001 is designed to avoid. Advinus has the composition of matter patent on GKM-001 for all major markets globally. Both the Single Ascending Dose data, in healthy and type II diabetics, and the Multiple Ascending Dose Study in Type II diabetics has shown that the molecule shows effective glucose lowering in a dose dependent manner and has excellent safety and tolerability profile over a 40-fold dose range. The pharmacokinetic properties of the molecule support once a day dosing. GKM-001 has the potential to be “First-in-Class” drug to address this large, growing and yet poorly addressed market.

Advinus also has identified a clinical candidate as a back-up to GKM-001, which is structurally different. In its portfolio, the company has a growing pipeline for COPD, sickle cell disease, inflammatory bowel disease, type 2 diabetes, acute and chronic pain and rheumatoid arthritis in various stages of late discovery and pre-clinical development.

Advinus Therapeutics team discovers novel molecule for treatment of diabetes

  • The first glucokinase modulator discovered and developed in India 
  • A new concept for the management of diabetes for patients, globally 
  • 100 per cent ‘made in India’ molecule for the treatment of diabetes 
  • IND approved by DGCI, Phase I clinical trial shows excellent safety and tolerance profiles with efficacy

Bangalore: Advinus Therapeutics (Advinus), the research-based pharmaceutical company founded by leading global pharmaceutical executives and promoted by the Tata group, today, announced the discovery of a novel molecule for the treatment of type II diabetes — GKM-001.The molecule is an activator of glucokinase; an enzyme that regulates glucose balance and insulin secretion in the body.

GKM-001 is a completely indigenously developed molecule and the initial clinical trials have shown excellent results for both safety and efficacy.

“Considering past failures of other companies on this target, our discovery programme primarily focused on identifying a molecule that would be efficacious without causing hypoglycaemia; a side effect associated with most compounds developed for this target.

“Recently completed Phase I data indicate that Advinus’ GKM–001 is a liver selective molecule that has overcome the biggest clinical challenge of hypoglycaemia. GKM-001 is differentiated from most other GK molecules in development due to this novel mechanism of action,” said Dr Rashmi Barbhaiya, MD and CEO, Advinus Therapeutics.

He further added, “We are very proud that GKM-001 is 100 per cent Indian. Advinus’s discovery team in Pune discovered the molecule and entire preclinical development was carried out at our centre in Bangalore. The Investigational New Drug (IND) application was filed with the DGCI for approval to initiate clinical trials in India within 34 months of initiation of the discovery programme. Subsequent to the approval of the IND, we have completed the Phase I Single Ascending Dose study in India within two months.”

GKM-001 is a novel molecule for the treatment of type II diabetes. It is the first glucokinase modulator discovered and developed in India and has potential to be both first or best in class. The success in discovering GKM-001 is attributed to the science-driven efforts in Advinus laboratories and ‘breaking the conventional mold’ for selection of a drug candidate. Advinus has ‘composition of matter’ patent on the molecule for all major markets globally. Glucokinase as a class of target is considered to be novel as currently there is no product in the market or in late clinical trials. The strategy for early clinical development revolved around assessing safety (particularly hypoglycaemia) and early assessment of therapeutic activity (glucose lowering and other biomarkers) in type II diabetics. The Phase I data, in both healthy and type II diabetics, shows excellent safety and tolerability over a 40-fold dose range and desirable pharmacokinetic properties consistent with ‘once a day’ dosing. The next wave of clinical studies planned continues on this strategy of early testing in type II diabetics.

Right behind the lead candidate GKM-001, Advinus has a rich pipeline of back up compounds on the same target. These include several structurally different compounds with diverse potency, unique pharmacology and tissue selectivity. Having discovered the molecule with early indication of wide safety margins, desired efficacy and pharmacokinetic profiles, the company now seeks to out-licence GKM-001 and its discovery portfolio.

Kasim A. Mookhtiar, , Debnath Bhuniya, Siddhartha De, Anita Chugh, Jayasagar
Gundu, Venkata Palle, Dhananjay Umrani, Nimish Vachharajani, Vikram
Ramanathan and Rashmi H. Barbhaiya
Advinus Therapeutics Ltd, Hinjewadi, Pune – 411057, and Peenya Industrial Area,
Bangalore – 560058, India
REFERENCES

patent

wo 2008104994

wo 2008 149382

wo 2009047798
WO2008104994A2* 25 Feb 2008 4 Sep 2008 Advinus Therapeutics Private L 2,2,2-tri-substituted acetamide derivatives as glucokinase activators, their process and pharmaceutical application

///////GKM 001, pipeline, Diabetes, Advinus, type II diabetes, glucokinase modulator, Rashmi Barbhaiya

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Liposomes, Lipidomics and Metabolism

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Building a Better Liposome

Computational models suggest new design for nanoparticles used in targeted drug delivery.

http://www.technologynetworks.com/Metabolomics/news.aspx?ID=184147

Using computational modeling, researchers at Carnegie Mellon University, the Colorado School of Mines and the University of California, Davis have come up with a design for a better liposome. Their findings, while theoretical, could provide the basis for efficiently constructing new vehicles for nanodrug delivery.

Liposomes are small containers with shells made of lipids, the same material that makes up the cell membrane. In recent years, liposomes have been used for targeted drug delivery. In this process, the membrane of a drug-containing liposome is engineered to contain proteins that will recognize and interact with complementary proteins on the membrane of a diseased or dysfunctional cell. After the drug-containing liposomes are administered, they travel through the body, ideally connecting with targeted cells where they release the drug.

liposome_853x480-min.jpg

This packaging technique is often used with highly toxic nanodrugs, like chemotherapy drugs, in an attempt to prevent the free drug from damaging non-cancerous cells. However, studies of this model of delivery have shown that in many cases less than 10 percent of the drugs transported by liposomes end up in tumor cells. Often, the liposome breaks open before it reaches a tumor cell and the drug is absorbed into the body’s organs, including the liver and spleen, resulting in toxic side effects.

“Even with current forms of targeted drug delivery, treatments like chemotherapy are still very brutal. We wanted to see how we could make targeted drug delivery better,” said Markus Deserno, professor of physics at Carnegie Mellon and a member of the university’s Center for Membrane Biology and Biophysics.

Deserno and colleagues propose that targeted drug delivery can be improved by making more stable liposomes. Using three different types of computer modeling, they have shown that liposomes can be made sturdier by incorporating a nanoparticle core made of a material like gold or iron and connecting that core to the liposome’s membrane using polymer tethers. The core and tethers act as a hub-and-spoke-like scaffold and shock-absorber system that help the liposome to weather the stresses and strains it encounters as it travels through the body to its target.

Francesca Stanzione and Amadeu K. Sum of the Colorado School of Mines conducted a fine-grained simulation that looked at how the polymer tethers anchor the liposome’s membrane at an atomistic level. Roland Faller of UC Davis did a meso-scale simulation that looked how a number of tethers held on to a small patch of membrane. Each of these simulations allowed researchers to look at smaller components of the liposome, nanoparticle core and tethers, but not the entire structure.

To see the entire structure, Carnegie Mellon’s Deserno and Mingyang Hu developed a coarse-grained model that represents groupings of components rather than individual atoms. For example, one lipid in the cell membrane might have 100 atoms. In a fine-grain simulation, each atom would be represented. In Deserno’s coarse grain simulation, those atoms might be represented by only three pieces instead of 100.

“Its unfeasible to look at the complete construct at an atomistic level. There are too many atoms to consider, and the timescale is too long. Even with the most advanced supercomputer, we wouldn’t have the power to run an atom-level simulation,” Deserno said. “But the physics that matters isn’t locally specific. It’s more like soft matter physics, which can be described at a much coarser resolution.”

Deserno’s simulation allowed the researchers to see how the entire reinforced liposome construct responded to stress and strain. They proposed that if a liposome was given the right-sized hub and tethers, its membrane would be much more resilient, bending to absorb impact and pressure.

Additionally, they were able to simulate how to best assemble the liposome, hub and tether system. They found that if the hub and tether are attached and placed in a solution of lipids, and solvent conditions are suitably chosen, a correctly sized liposome would self-assemble around the hub and tethers.

The researchers hope that chemists and drug developers will one day be able to use their simulations to determine what size core and polymer tethers they would need to effectively secure a liposome designed to deliver a specific drug or other nanoparticle. Using such simulations could narrow down the design parameters, speed up the development process and reduce costs.

 

Lipotype GmbH and NIHS Collaborate

http://www.technologynetworks.com/Metabolomics/news.aspx?ID=184363

NIHS to use the Lipotype Shotgun Lipidomics Technology for lipid analysis.

Lipotype GmbH and the Nestlé Institute of Health Sciences (NIHS) have collaborated to employ the innovative Lipotype Shotgun Lipidomics Technology to analyze lipids in blood for nutritional research. Recently, Lipotype and NIHS have jointly published results of the robustness of the Lipotype Technology. Lipotype envisions a future use of its technology in clinical diagnostics screens for establishing reliable lipid diagnostic biomarkers.

Innovative Lipotype Technology for lipid analysis
The purpose of this collaboration is to enable NIHS to use the Lipotype Shotgun Lipidomics Technology for lipid analysis. The mass spectrometry-based Lipotype technology covers a broad spectrum of lipid molecules and delivers quantitative results in high-throughput. The Nestlé Institute of Health Sciences uses this technology platform for nutritional research. NIHS is a specialized biomedical research institute and is part of Nestlé’s global Research & Development network.

Joint research project reveals robustness of Lipotype Technology
During the collaboration, Lipotype and NIHS conducted a joint research project and demonstrated that the Lipotype technology was robust enough to deliver data with high precision and negligible technical variation between different sites. In addition, important features are the high coverage and throughput, which were confirmed when applying the Lipotype technology.

Lipotype envisions these as important features, required for future use in clinical diagnostics screens, in order to establish and validate reliable lipid diagnostic biomarkers. The results have been published in October 2015, in the European Journal of Lipid Science and Technology (Surma et al. “An Automated Shotgun Lipidomics Platform for High Throughput, Comprehensive, and Quantitative Analysis of Blood Plasma Intact Lipids.”).

Lipids play an important role for health and disease
Lipotype is a spin-off company of the Max-Planck-Institute of Molecular Cell Biology and Genetics in Dresden, Germany. Prof. Kai Simons, CEO of Lipotype explains: “We developed a novel Shotgun-Lipidomics technology to analyze lipids in blood and other biological samples. Our analysis is quick and covers hundreds of lipid molecules at the same time. Our technology can be used to identify disease related lipid signatures.”

 

New Treatment for Obesity Developed

http://www.technologynetworks.com/Metabolomics/news.aspx?ID=183998

Researchers at the University of Liverpool, working with a global healthcare company, have helped develop a new treatment for obesity.
The treatment, which is a once-daily injectable derivative of a metabolic hormone called GLP-1 conventionally used in the treatment of type 2 diabetes, has proved successful in helping non-diabetic obese patients lose weight.

Professor John Wilding, who leads Obesity and Endocrinology research in the Institute of Ageing and Chronic Disease, investigates the pathophysiology and treatment of both obesity and type 2 diabetes and is applying his expertise in this area to work with, and often act as a consultant for, a number of large pharmaceutical companies looking to develop new treatments for obesity and diabetes.

Exciting development

Professor Wilding, said: “The biology of GLP-1 has been a focus of my research for 20 years; in particular when I was working at Hammersmith Hospital in London, I was part of the team that demonstrated that it was involved in appetite regulation; work on GLP-1 has continued during my time in Liverpool. Being involved in the development of a treatment, from the basic research right through to clinical trials in patients is very exciting”.

“It is likely that the treatment will be used initially in very specific situations, such as helping patients who are severely obese. It differs from current treatments used for diabetes, as it has stronger appetite regulating effects but no greater effect on glucose control.”

In 2014 more than 1.9 billion adults worldwide were classed as obese by the World Health Organisation; in the UK numbers have more than tripled since 1980. This Obesity can lead to other serious health-related illnesses including type 2 diabetes, hypertension and obstructive sleep apnoea as well as increasing the risk for many common cancers.

The drug has been approved in the European Union, but has not yet launched in the UK.

Professor Wilding added: “Consultancy like this can help relationship and reputation building and informs my research keeping it at the forefront of developments. It also brings many other benefits such as publications and income generation, which can help support other research, for example by such as funding for pilot projects that can lead to grant applications and investigator-initiated trials funded by the company”.

 

Evidence of How Incurable Cancer Develops

http://www.technologynetworks.com/Metabolomics/news.aspx?ID=184346

Researchers in the West Midlands have made a breakthrough in explaining how an incurable type of blood cancer develops from an often symptomless prior blood disorder.

The findings could lead to more effective treatments and ways to identify those most at risk of developing the cancer.

All patients diagnosed with myeloma, a cancer of the blood-producing bone marrow, first develop a relatively benign condition called ‘monoclonal gammopathy of undetermined significance’ or ‘MGUS’.

MGUS is fairly common in the older population and only progresses to cancer in approximately one in 100 cases. However, currently there is no way of accurately predicting which patients with MGUS are likely to go on to get myeloma.

Myeloma is diagnosed in around 4,000 people each year in the UK. It specifically affects antibody-producing white blood cells found in the bone marrow, called plasma cells. The researcher team from the University of Birmingham, New Cross and Heartlands Hospitals compared the cellular chemistry of bone marrow and blood samples taken from patients with myeloma, patients with MGUS and healthy volunteers.

Surprisingly, the researchers found that the metabolic activity of the bone marrow of patients with MGUS was significantly different to plasma from healthy volunteers, but there were very few differences at all between the MGUS and myeloma samples. The research was funded by the blood cancer charity Bloodwise, which changed its name from Leukaemia & Lymphoma in September.

The findings suggest that the biggest metabolic changes occur with the development of the symptomless condition MGUS and not with the later progression to myeloma.

Dr Daniel Tennant, who led the research at the University of Birmingham, said, “Our findings show that very few changes are required for a MGUS patient to progress to myeloma as we now know virtually all patients with myeloma evolve from MGUS. A drug that interferes with these specific initial metabolic changes could make a very effective treatment for myeloma, so this is a very exciting discovery.”

The research team found over 200 products of metabolism differed between the healthy volunteers and patients with MGUS or myeloma, compared to just 26 differences between MGUS patients and myeloma patients. The researchers believe that these small changes could drive the key shifts in the bone marrow required to support myeloma growth.

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Turning genetic information into working proteins

Larry H Bernstein, MD, FCAP, Curator

Leaders in Pharmaceutical Intelligence

Series 2; 3.3

James E. Darnell Jr. (1930— )
Vincent Astor Professor Emeritus
2002 Albert Lasker Award for Special Achievement in Medical Science

Responsible for the various tasks required in turning genetic information into working proteins, ribonucleic acids are one of the most essential players in the life of a cell. First discovered in 1868, RNA today remains the subject of intense scientific scrutiny. Over the course of a career dedicated to understanding the intricate workings of gene transcription, Rockefeller University scientist James E. Darnell Jr. has revealed some of RNA’s most secretive and surprising mechanisms. For his half-century of illuminating research, Dr. Darnell received the 2002 Albert Lasker Award for Special Achievement in Medical Science.

In 1963, Dr. Darnell described a phenomenon he termed “RNA processing,” a step in the process of gene transcription, which had only recently been elucidated in bacterial systems. Working with mammalian cells — which differ from bacterial cells in that they contain a nucleus, where RNA is created — Dr. Darnell observed that very long strings of RNA disappear from the cell nucleus and that subsequently, shorter RNAs resembling the absent longer ones appear in the cytoplasm. Mammalian cells, he concluded, must distill their massive, immature nuclear RNA into shorter, mature forms that are individually coded for specific purposes by specific segments of the genome.

Dr. Darnell carried the principles of his finding — which he made in ribosomal RNA, part of the construction crew that builds cellular proteins — to other long nuclear RNA, including the longest one, which he named heterogeneous nuclear RNA (hnRNA). His hypothesis, that hnRNA is the precursor of the better known messenger RNA — which carries the genetic blueprint for protein building — soon bore fruit when he found a structural correlation between the two. Certain hnRNAs and nearly all messenger RNAs have a “tail” of adenine nucleotides at one end. Dr. Darnell followed this discovery with the observation that when an hnRNA string with an adenine tail disappears from the nucleus, a messenger RNA with the same tail then appears in the cytoplasm, suggesting a causal link between the two. When he found a second similarity — a cap at the end of the string opposite the adenine tail — he faced a conundrum. Scientific dogma had it that the order of nucleotides in any RNA mirrors that of DNA, whether the RNA is modeled from somewhere in the middle of the DNA or from one of the ends. The matching of a nuclear RNA to its cytoplasmic product by two end pieces glued together was surprising, but the concept was soon proven by colleagues at other institutions and called RNA splicing.

After a brief sojourn in Paris to work in François Jacob’s lab, Darnell worked at MIT, the Albert Einstein College of Medicine, and Rockefeller University on the relationship between mRNA and hnRNA. hnRNA was believed to be the precursor to mRNA, and despite making some key discoveries, Darnell admits that he could not free his imagination from the idea of colinearity and envision an hnRNA spliced to produce a smaller mRNA.

At this time, Darnell turned his attention to the question he had pondered since Paris: how were genes regulated in animal cells? This led to the discovery of the STAT and the Jak-STAT pathway of transcription control.

With the knowledge of RNA processing and splicing, Dr. Darnell next examined how cells begin the process of transcription and how they activate particular segments of DNA. Having moved to Rockefeller University in 1974, he found in the early 1980s that cells retain their specificity only in the context of their natural environment. Away from other liver cells, for example, a single liver cell stops producing liver-specific RNA, though it continues to make RNA for more generic cellular tasks. To pinpoint the signals responsible, which he believed must be coming from outside the cell, Dr. Darnell took a closer look at interferons (IFN), proteins that warn a cell when it’s time to raise its genetic defenses against harmful microbes.

Dr. Darnell’s laboratory studies how signals from the cell surface affect transcription of genes in the nucleus. Originally using interferon as a model cytokine, the Darnell group discovered that cell transcription was quickly changed by binding of cytokines to the cell surface. Introducing IFNβ into cell cultures, he watched as a particular type of mRNA accumulated in the cytoplasm, unaccompanied by any new protein synthesis. Analyzing the mRNA led him to the segment of DNA that had been activated, and the lack of new proteins told him that the cell contained its own, usually dormant, IFN-responsive transcription factor. By isolating a particular stretch of DNA from IFN-treated cells, he was able to call out of hiding the proteins that make up that factor, which, partly because they respond to signals very quickly, he called “STATs.” Dr. Darnell then traced the chemical relay that activates the STATs after IFN contact, called the Jak-Stat pathway.

The bound interferon led to the tyrosine phosphorylation of latent cytoplasmic proteins now called STATs (signal transducers and activators of transcription) that dimerize by reciprocal phosphotyrosine-SH2 interchange. They accumulate in the nucleus, bind DNA and drive transcription. This pathway has proved to be of wide importance, with seven STATs now known in mammals that take part in a wide variety of developmental and homeostatic events in all multicellular animals. Crystallographic analysis defined functional domains in the STATs, and current attention is focused on two areas: how the STATs complete their cycle of activation and inactivation, which requires regulated tyrosine dephosphorylation; and how persistent activation of STAT3 that occurs in a high proportion of many human cancers contributes to blocking apoptosis in cancer cells. Current efforts are devoted to inhibiting STAT3 with modified peptides that can enter cells.

 

Dr. Darnell received his M.D. in 1955 from the Washington University School of Medicine. His career has included poliovirus research with Harry Eagle at the National Institute of Allergy and Infectious Diseases, research with François Jacob at the Pasteur Institute in Paris and academic appointments at the Massachusetts Institute of Technology, the Albert Einstein College of Medicine and Columbia University. In 1974 Dr. Darnell joined Rockefeller as Vincent Astor Professor, and from 1990 to 1991 he was vice president for academic affairs.

A member of the National Academy of Sciences since 1973, he has received numerous awards, including the 2012 Albany Medical Center Prize in Medicine and Biomedical Research, the 2003 National Medal of Science, the 2002 Albert Lasker Award for Special Achievement in Medical Science, the 1997 Passano Award, the 1994 Paul Janssen Prize in Advanced Biotechnology and Medicine and the 1986 Gairdner Foundation International Award.

He is the coauthor with S.E. Luria of General Virology and the founding author with Harvey Lodish and David Baltimore of Molecular Cell Biology, now in its seventh edition. His book RNA, Life’s Indispensable Molecule was published in July 2011 by Cold Spring Harbor Laboratory Press. He is a member of the American Academy of Arts and Sciences and a foreign member of The Royal Society and The Royal Swedish Academy of Sciences.

 

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Metabolic Genomics and Pharmaceutics, Vol. 1 of BioMed Series D available on Amazon Kindle

Metabolic Genomics and Pharmaceutics, Vol. 1 of BioMed Series D available on Amazon Kindle

Reporter: Stephen S Williams, PhD

Article ID #180: Metabolic Genomics and Pharmaceutics, Vol. 1 of BioMed Series D available on Amazon Kindle. Published on 8/15/2015

WordCloud Image Produced by Adam Tubman

Leaders in Pharmaceutical Business Intelligence would like to announce the First volume of their BioMedical E-Book Series D:

Metabolic Genomics & Pharmaceutics, Vol. I

SACHS FLYER 2014 Metabolomics SeriesDindividualred-page2

which is now available on Amazon Kindle at

http://www.amazon.com/dp/B012BB0ZF0.

This e-Book is a comprehensive review of recent Original Research on  METABOLOMICS and related opportunities for Targeted Therapy written by Experts, Authors, Writers. This is the first volume of the Series D: e-Books on BioMedicine – Metabolomics, Immunology, Infectious Diseases.  It is written for comprehension at the third year medical student level, or as a reference for licensing board exams, but it is also written for the education of a first time baccalaureate degree reader in the biological sciences.  Hopefully, it can be read with great interest by the undergraduate student who is undecided in the choice of a career. The results of Original Research are gaining value added for the e-Reader by the Methodology of Curation. The e-Book’s articles have been published on the Open Access Online Scientific Journal, since April 2012.  All new articles on this subject, will continue to be incorporated, as published with periodical updates.

We invite e-Readers to write an Article Reviews on Amazon for this e-Book on Amazon.

All forthcoming BioMed e-Book Titles can be viewed at:

http://pharmaceuticalintelligence.com/biomed-e-books/

Leaders in Pharmaceutical Business Intelligence, launched in April 2012 an Open Access Online Scientific Journal is a scientific, medical and business multi expert authoring environment in several domains of  life sciences, pharmaceutical, healthcare & medicine industries. The venture operates as an online scientific intellectual exchange at their website http://pharmaceuticalintelligence.com and for curation and reporting on frontiers in biomedical, biological sciences, healthcare economics, pharmacology, pharmaceuticals & medicine. In addition the venture publishes a Medical E-book Series available on Amazon’s Kindle platform.

Analyzing and sharing the vast and rapidly expanding volume of scientific knowledge has never been so crucial to innovation in the medical field. WE are addressing need of overcoming this scientific information overload by:

  • delivering curation and summary interpretations of latest findings and innovations on an open-access, Web 2.0 platform with future goals of providing primarily concept-driven search in the near future
  • providing a social platform for scientists and clinicians to enter into discussion using social media
  • compiling recent discoveries and issues in yearly-updated Medical E-book Series on Amazon’s mobile Kindle platform

This curation offers better organization and visibility to the critical information useful for the next innovations in academic, clinical, and industrial research by providing these hybrid networks.

Table of Contents for Metabolic Genomics & Pharmaceutics, Vol. I

Chapter 1: Metabolic Pathways

Chapter 2: Lipid Metabolism

Chapter 3: Cell Signaling

Chapter 4: Protein Synthesis and Degradation

Chapter 5: Sub-cellular Structure

Chapter 6: Proteomics

Chapter 7: Metabolomics

Chapter 8:  Impairments in Pathological States: Endocrine Disorders; Stress

                   Hypermetabolism and Cancer

Chapter 9: Genomic Expression in Health and Disease 

 

Summary 

Epilogue

 

 

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Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle

Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle

Reporter: Stephen J Williams, PhD

Article ID #179: Cancer Biology and Genomics for Disease Diagnosis (Vol. I) Now Available for Amazon Kindle. Published on 8/14/2015

WordCloud Image Produced by Adam Tubman

Leaders in Pharmaceutical Business Intelligence would like to announce the First volume of their BioMedical E-Book Series C: e-Books on Cancer & Oncology

Volume One: Cancer Biology and Genomics for Disease Diagnosis

CancerandOncologyseriesCcoverwhich is now available on Amazon Kindle at                          http://www.amazon.com/dp/B013RVYR2K.

This e-Book is a comprehensive review of recent Original Research on Cancer & Genomics including related opportunities for Targeted Therapy written by Experts, Authors, Writers. This ebook highlights some of the recent trends and discoveries in cancer research and cancer treatment, with particular attention how new technological and informatics advancements have ushered in paradigm shifts in how we think about, diagnose, and treat cancer. The results of Original Research are gaining value added for the e-Reader by the Methodology of Curation. The e-Book’s articles have been published on the Open Access Online Scientific Journal, since April 2012.  All new articles on this subject, will continue to be incorporated, as published with periodical updates.

We invite e-Readers to write an Article Reviews on Amazon for this e-Book on Amazon. All forthcoming BioMed e-Book Titles can be viewed at:

http://pharmaceuticalintelligence.com/biomed-e-books/

Leaders in Pharmaceutical Business Intelligence, launched in April 2012 an Open Access Online Scientific Journal is a scientific, medical and business multi expert authoring environment in several domains of  life sciences, pharmaceutical, healthcare & medicine industries. The venture operates as an online scientific intellectual exchange at their website http://pharmaceuticalintelligence.com and for curation and reporting on frontiers in biomedical, biological sciences, healthcare economics, pharmacology, pharmaceuticals & medicine. In addition the venture publishes a Medical E-book Series available on Amazon’s Kindle platform.

Analyzing and sharing the vast and rapidly expanding volume of scientific knowledge has never been so crucial to innovation in the medical field. WE are addressing need of overcoming this scientific information overload by:

  • delivering curation and summary interpretations of latest findings and innovations
  • on an open-access, Web 2.0 platform with future goals of providing primarily concept-driven search in the near future
  • providing a social platform for scientists and clinicians to enter into discussion using social media
  • compiling recent discoveries and issues in yearly-updated Medical E-book Series on Amazon’s mobile Kindle platform

This curation offers better organization and visibility to the critical information useful for the next innovations in academic, clinical, and industrial research by providing these hybrid networks.

Table of Contents for Cancer Biology and Genomics for Disease Diagnosis

Preface

Introduction  The evolution of cancer therapy and cancer research: How we got here?

Part I. Historical Perspective of Cancer Demographics, Etiology, and Progress in Research

Chapter 1:  The Occurrence of Cancer in World Populations

Chapter 2.  Rapid Scientific Advances Changes Our View on How Cancer Forms

Chapter 3:  A Genetic Basis and Genetic Complexity of Cancer Emerge

Chapter 4: How Epigenetic and Metabolic Factors Affect Tumor Growth

Chapter 5: Advances in Breast and Gastrointestinal Cancer Research Supports Hope for Cure

Part II. Advent of Translational Medicine, “omics”, and Personalized Medicine Ushers in New Paradigms in Cancer Treatment and Advances in Drug Development

Chapter 6:  Treatment Strategies

Chapter 7:  Personalized Medicine and Targeted Therapy

Part III.Translational Medicine, Genomics, and New Technologies Converge to Improve Early Detection

Chapter 8:  Diagnosis                                     

Chapter 9:  Detection

Chapter 10:  Biomarkers

Chapter 11:  Imaging In Cancer

Chapter 12: Nanotechnology Imparts New Advances in Cancer Treatment, Detection, &  Imaging                                 

Epilogue by Larry H. Bernstein, MD, FACP: Envisioning New Insights in Cancer Translational Biology

 

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Therapeutic Implications for Targeted Therapy from the Resurgence of Warburg ‘Hypothesis’

Writer and Curator: Larry H. Bernstein, MD, FCAP 

(Note that each portion of the discussion is followed by a reference)

It is now a time to pause after almost a century of a biological scientific discoveries that have transformed the practice of medicine and impacted the lives of several generations of young minds determined to probe the limits of our knowledge.  In the century that we have entered into the scientific framework of medicine has brought together a difficult to grasp evolution of the emergence of human existence from wars, famine, droughts, storms, infectious diseases, and insect born pestilence with betterment of human lives, only unevenly divided among societal classes that have existed since time immemorial. In this short time span there have emerged several generations of physicians who have benefited from a far better medical education that their forebears could have known. In this expansive volume on cancer, we follow an incomplete and continuing challenge to understand cancer, a disease that has become associated with longer life spans in developed nations.

While there are significant improvements in the diagnosis and treatment of cancers, there is still a personal as well as locality factor in the occurrence of this group of diseases, which has been viewed incorrectly as a “dedifferentiation” of mature tissue types and the emergence of a cell phenotype that is dependent on glucose, reverts to a cancer “stem cell type” (loss of stemness), loses cell to cell adhesion, loses orderly maturation, and metastasizes to distant sites. At the same time, physician and nurses are stressed in the care of patients by balancing their daily lives and maintaining a perspective.

The conceptual challenge of cancer diagnosis and management has seemed insurmountable, but owes much to the post World War I activities of Otto Heinrich Warburg. It was Warburg who made the observation that cancer cells metabolize glucose by fermentation in much the way Pasteur 60 years earlier observed fermentation of yeast cells. This metabolic phenomenon occurs even in the presence of an oxygen supply, which would provide a huge deficit in ATP production compared with respiration. The cancer cell is “addicted to glucose” and produced lactic acid. Warburg was awarded the Nobel Prize in Medicine for this work in 1931.

In the last 15 years there has been a resurgence of work on the Warburg effect that sheds much new light on the process that was not previously possible, with significant therapeutic implications.  In the first place, the metabolic mechanism for the Warburg effect was incomplete even at the beginning of the 21st century.  This has been partly rectified with the enlightening elucidation of genome modifications, cellular metabolic regulation, and signaling pathways.

The following developments have become central to furthering our understanding of malignant transformation.

  1. There is usually an identifiable risk factor, such as, H. pylori, or of a chronic inflammatory state, as in the case of Barrett’s esophagus.
  2. There are certain changes in glucose metabolism that have been unquestionably been found in the evolution of this disease. The changes are associated with major changes in metabolic pathways, miRN signaling, and the metabolism geared to synthesis of cells with an impairment of the cell death cycle. In these changes, mitochondrial function is central to both the impaired respiration and the autophagy geared to the synthesis of cancer cells.

The emergence of this cell prototype is characterized by the following, again related to the Warburg effect:

  1. Cancer cells oxidize a decreased fraction of the pyruvate generated from glycolysis
  2. The mitochondrial pyruvate carrier (MPC), composed of the products of the MPC1 and MPC2 genes, modulates fractional pyruvate oxidation. MPC1 is deleted or underexpressed in multiple cancers and correlates with poor prognosis.
  3. Cancer cells tend to express a partially inhibited splice variant of pyruvate kinase (PK-M2), leading to decreased pyruvate production.
  4. The two proteins that mediate pyruvate conversion to lactate and its export, M-type lactate dehydrogenase and the monocarboxylate transporter MCT-4, are commonly upregulated in cancer cells leading to decreased pyruvate oxidation.
  5. The enzymatic step following mitochondrial entry is the conversion of pyruvate to acetyl-CoA by the pyruvate dehydrogenase (PDH) complex. Cancer cells frequently exhibit increased expression of the PDH kinase PDK1, which phosphorylates and inactivates PDH. This PDH regulatory mechanism is required for oncogene induced transformation and reversed in oncogene-induced senescence.
  6. The PDK inhibitor dichloroacetate has shown some clinical efficacy, which correlates with increased pyruvate oxidation. One of the simplest mechanisms to explain decreased mitochondrial pyruvate oxidation in cancer cells, a loss of mitochondrial pyruvate import, has been observed repeatedly over the past 40 years. This process has been impossible to study at a molecular level until recently, however, as the identities of the protein(s) that mediate mitochondrial pyruvate uptake were unknown.
  7. The mitochondrial pyruvate carrier (MPC) as a multimeric complex that is necessary for efficient mitochondrial pyruvate uptake. The MPC contains two distinct proteins, MPC1 and MPC2; the absence of either leads to a loss of mitochondrial pyruvate uptake and utilization in yeast, flies, and mammalian cells.

A Role for the Mitochondrial Pyruvate Carrier as a Repressor of the Warburg Effect and Colon Cancer Cell Growth

John C. Schell, Kristofor A. Olson, Lei Jiang, Amy J. Hawkins, et al.
Molecular Cell Nov 6, 2014; 56: 400–413.
http://dx.doi.org/10.1016/j.molcel.2014.09.026

In addition to the above, the following study has therapeutic importance:

Glycolysis has become a target of anticancer strategies. Glucose deprivation is sufficient to induce growth inhibition and cell death in cancer cells. The increased glucose transport in cancer cells has been attributed primarily to the upregulation of glucose transporter 1 (Glut1),  1 of the more than 10 glucose transporters that are responsible for basal glucose transport in almost all cell types. Glut1 has not been targeted until very recently due to the lack of potent and selective inhibitors.

First, Glut1 antibodies were shown to inhibit cancer cell growth. Other Glut1 inhibitors and glucose transport inhibitors, such as fasentin and phloretin, were also shown to be effective in reducing cancer cell growth. A group of inhibitors of glucose transporters has been recently identified with IC50 values lower than 20mmol/L for inhibiting cancer cell growth. However, no animal or detailed mechanism studies have been reported with these inhibitors.

Recently, a small molecule named STF-31 was identified that selectively targets the von Hippel-Lindau (VHL) deficient kidney cancer cells. STF-31 inhibits VHL deficient cancer cells by inhibiting Glut1. It was further shown that daily intraperitoneal injection of a soluble analogue of STF-31 effectively reduced the growth of tumors of VHL-deficient cancer cells grafted on nude mice. On the other hand, STF-31 appears to be an inhibitor with a narrow cell target spectrum.

These investigators recently reported the identification of a group of novel small compounds that inhibit basal glucose transport and reduce cancer cell growth by a glucose deprivation–like mechanism. These compounds target Glut1 and are efficacious in vivo as anticancer agents. A novel representative compound WZB117 not only inhibited cell growth in cancer cell lines but also inhibited cancer growth in a nude mouse model. Daily intraperitoneal injection of WZB117 resulted in a more than 70% reduction in the size of human lung cancer of A549 cell origin. Mechanism studies showed that WZB117 inhibited glucose transport in human red blood cells (RBC), which express Glut1 as their sole glucose transporter. Cancer cell treatment with WZB117 led to decreases in levels of Glut1 protein, intracellular ATP, and glycolytic enzymes. All these changes were followed by increase in ATP sensing enzyme AMP-activated protein kinase (AMPK) and declines in cyclin E2 as well as phosphorylated retinoblastoma, resulting in cell-cycle arrest, senescence, and necrosis. Addition of extracellular ATP rescued compound-treated cancer cells, suggesting that the reduction of intracellular ATP plays an important role in the anticancer mechanism of the molecule.

A Small-Molecule Inhibitor of Glucose Transporter 1 Downregulates Glycolysis, Induces Cell-Cycle Arrest, and Inhibits Cancer Cell Growth In Vitro and In Vivo

Yi Liu, Yanyan Cao, Weihe Zhang, Stephen Bergmeier, et al.
Mol Cancer Ther Aug 2012; 11(8): 1672–82
http://dx.doi.org://10.1158/1535-7163.MCT-12-0131

Alterations in cellular metabolism are among the most consistent hallmarks of cancer. These investigators have studied the relationship between increased aerobic lactate production and mitochondrial physiology in tumor cells. To diminish the ability of malignant cells to metabolize pyruvate to lactate, M-type lactate dehydrogenase levels were knocked down by means of LDH-A short hairpin RNAs. Reduction in LDH-A activity resulted in stimulation of mitochondrial respiration and decrease of mitochondrial membrane potential. It also compromised the ability of these tumor cells to proliferate under hypoxia. The tumorigenicity of the LDH-A-deficient cells was severely diminished, and this phenotype was reversed by complementation with the human ortholog LDH-A protein. These results demonstrate that LDH-A plays a key role in tumor maintenance.

The results are consistent with a functional connection between alterations in glucose metabolism and mitochondrial physiology in cancer. The data also reflect that the dependency of tumor cells on glucose metabolism is a liability for these cells under limited-oxygen conditions. Interfering with LDH-A activity as a means of blocking pyruvate to lactate conversion could be exploited therapeutically. Because individuals with complete deficiency of LDH-A do not show any symptoms under ordinary circumstances, the genetic data suggest that inhibition of LDH-A activity may represent a relatively nontoxic approach to interfere with tumor growth.

Attenuation of LDH-A expression uncovers a link between glycolysis, mitochondrial physiology, and tumor maintenance

Valeria R. Fantin Julie St-Pierre and Philip Leder
Cancer Cell Jun 2006; 9: 425–434.
http://dx.doi.org:/10.1016/j.ccr.2006.04.02

The widespread clinical use of positron-emission tomography (PET) for the detection of aerobic glycolysis in tumors and recent findings have rekindled interest in Warburg’s theory. Studies on the physiological changes in malignant conversion provided a metabolic signature for the different stages of tumorigenesis; during tumorigenesis, an increase in glucose uptake and lactate production have been detected. The fully transformed state is most dependent on aerobic glycolysis and least dependent on the mitochondrial machinery for ATP synthesis.

Tumors ferment glucose to lactate even in the presence of oxygen (aerobic glycolysis; Warburg effect). The pentose phosphate pathway (PPP) allows glucose conversion to ribose for nucleic acid synthesis and glucose degradation to lactate. The nonoxidative part of the PPP is controlled by transketolase enzyme reactions. We have detected upregulation of a mutated transketolase transcript (TKTL1) in human malignancies, whereas transketolase (TKT) and transketolase-like-2 (TKTL2) transcripts were not upregulated. Strong TKTL1 protein expression was correlated to invasive colon and urothelial tumors and to poor patients outcome. TKTL1 encodes a transketolase with unusual enzymatic properties, which are likely to be caused by the internal deletion of conserved residues. We propose that TKTL1 upregulation in tumors leads to enhanced, oxygen-independent glucose usage and a lactate based matrix degradation. As inhibition of transketolase enzyme reactions suppresses tumor growth and metastasis, TKTL1 could be the relevant target for novel anti-transketolase cancer therapies. We suggest an individualized cancer therapy based on the determination of metabolic changes in tumors that might enable the targeted inhibition of invasion and metastasis.

Other important links between cancer-causing genes and glucose metabolism have been already identified. Activation of the oncogenic kinase Akt has been shown to stimulate glucose uptake and metabolism in cancer cells and renders these cells susceptible to death in response to glucose withdrawal. Such tumor cells have been shown to be dependent on glucose because the ability to induce fatty acid oxidation in response to glucose deprivation is impaired by activated Akt. In addition, AMP-activated protein kinase (AMPK) has been identified as a link between glucose metabolism and the cell cycle, thereby implicating p53 as an essential component of metabolic cell-cycle control.

Expression of transketolase TKTL1 predicts colon and urothelial cancer patient survival: Warburg effect reinterpreted

S Langbein, M Zerilli, A zur Hausen, W Staiger, et al.
British Journal of Cancer (2006) 94, 578–585.
http://dx.doi.org:/10.1038/sj.bjc.6602962

The unique metabolic profile of cancer (aerobic glycolysis) might confer apoptosis resistance and be therapeutically targeted. Compared to normal cells, several human cancers have high mitochondrial membrane potential (DJm) and low expression of the K+ channel Kv1.5, both contributing toapoptosis resistance. Dichloroacetate (DCA) inhibits mitochondrial pyruvate dehydrogenase kinase (PDK), shifts metabolism from glycolysis to glucose oxidation, decreases DJm, increases mitochondrial H2O2, and activates Kv channels in all cancer, but not normal, cells; DCA upregulates Kv1.5 by an NFAT1-dependent mechanism. DCA induces apoptosis, decreases proliferation, and inhibits tumor growth, without apparent toxicity. Molecular inhibition of PDK2 by siRNA mimics DCA. The mitochondria-NFAT-Kv axis and PDK are important therapeutic targets in cancer; the orally available DCA is a promising selective anticancer agent.

Cancer progression and its resistance to treatment depend, at least in part, on suppression of apoptosis. Although mitochondria are recognized as regulators of apoptosis, their importance as targets for cancer therapy has not been adequately explored or clinically exploited. In 1930, Warburg suggested that mitochondrial dysfunction in cancer results in a characteristic metabolic phenotype, that is, aerobic glycolysis (Warburg, 1930). Positron emission tomography (PET) imaging has now confirmed that most malignant tumors have increased glucose uptake and metabolism. This bioenergetic feature is a good marker of cancer but has not been therapeutically pursued..

The small molecule DCA is a metabolic modulator that has been used in humans for decades in the treatment of lactic acidosis and inherited mitochondrial diseases. Without affecting normal cells, DCA reverses the metabolic electrical remodeling that we describe in several cancer lines (hyperpolarized mitochondria, activated NFAT1, downregulated Kv1.5), inducing apoptosis and decreasing tumor growth. DCA in the drinking water at clinically relevant doses for up to 3 months prevents and reverses tumor growth in vivo, without apparent toxicity and without affecting hemoglobin, transaminases, or creatinine levels. The ease of delivery, selectivity, and effectiveness  make DCA an attractive candidate for proapoptotic cancer therapy which can be rapidly translated into phase II–III clinical trials.

A Mitochondria-K+ Channel Axis Is Suppressed in Cancer and Its Normalization Promotes Apoptosis and Inhibits Cancer Growth

Sebastien Bonnet, Stephen L. Archer, Joan Allalunis-Turner, et al.

Cancer Cell Jan 2007; 11: 37–51.
http://dx.doi.org:/10.1016/j.ccr.2006.10.020

Tumor cells, just as other living cells, possess the potential for proliferation, differentiation, cell cycle arrest, and apoptosis. There is a specific metabolic phenotype associated with each of these conditions, characterized by the production of both energy and special substrates necessary for the cells to function in that particular state. Unlike that of normal living cells, the metabolic phenotype of tumor cells supports the proliferative state. Aim: To present the metabolic hypothesis that (1) cell transformation and tumor growth are associated with the activation of metabolic enzymes that increase glucose carbon utilization for nucleic acid synthesis, while enzymes of the lipid and amino acid synthesis pathways are activated in tumor growth inhibition, and (2) phosphorylation and allosteric and transcriptional regulation of intermediary metabolic enzymes and their substrate availability together mediate and sustain cell transformation from one condition to another. Conclusion: Evidence is presented that demonstrates opposite changes in metabolic phenotypes induced by TGF-β, a cell transforming agent, and tumor growth-inhibiting phytochemicals such as genistein and Avemar, or novel synthetic antileukemic drugs such as STI571 (Gleevec).  Intermediary metabolic enzymes that mediate the growth signaling pathways and promote malignant cell transformation may serve as high efficacy nongenetic novel targets for cancer therapies.

A Metabolic Hypothesis of Cell Growth and Death in Pancreatic Cancer

Laszlo G. Boros, Wai-Nang Paul Lee, and Vay Liang W. Go
Pancreas 2002; 24(1):26–33

Clear cell renal cell carcinoma (ccRCC) is the most common pathological subtype of kidney cancer. Here, we integrated an unbiased genome-wide RNA interference screen for ccRCC survival regulators with an analysis of recurrently overexpressed genes in ccRCC to identify new therapeutic targets in this disease. One of the most potent survival regulators, the monocarboxylate transporter MCT4 (SLC16A3), impaired ccRCC viability in all eight ccRCC lines tested and was the seventh most overexpressed gene in a meta-analysis of five ccRCC expression datasets.

MCT4 silencing impaired secretion of lactate generated through glycolysis and induced cell cycle arrest and apoptosis. Silencing MCT4 resulted in intracellular acidosis, and reduction in intracellular ATP production together with partial reversion of the Warburg effect in ccRCC cell lines. Intra-tumoral heterogeneity in the intensity of MCT4 protein expression was observed in primary ccRCCs.

MCT4 protein expression analysis based on the highest intensity of expression in primary ccRCCs was associated with poorer relapse-free survival, whereas modal intensity correlated with Fuhrman nuclear grade. Consistent with the potential selection of subclones enriched for MCT4 expression during disease progression, MCT4 expression was greater at sites of metastatic disease. These data suggest that MCT4 may serve as a novel metabolic target to reverse the Warburg effect and limit disease progression in ccRCC.

Clear cell carcinoma (ccRCC) is the commonest subtype of renal cell carcinoma, accounting for 80% of cases. These tumors are highly resistant to cytotoxic chemotherapy and until recently, systemic treatment options for advanced ccRCC were limited to cytokine based therapies, such as interleukin-2 and interferon-α. Recently, anti-angiogenic drugs and mTOR inhibitors, all targeting the HIF–VEGF axis which is activated in up to 91% of ccRCCs through loss of the VHL tumor suppressor gene [1], have been shown to be effective in metastatic ccRCC [2–5]. Although these drugs increase overall survival to more than 2 years [6], resistance invariably occurs, making the identification of new molecular targets a major clinical need to improve outcomes in patients with metastatic ccRCC.

Genome-wide RNA interference analysis of renal carcinoma survival regulators identifies MCT4 as a Warburg effect metabolic target

Marco Gerlinger, Claudio R Santos, Bradley Spencer-Dene, et al.
J Pathol 2012; 227: 146–156
http://dx.doi.org:/10.1002/path.4006

Hypoxia-inducible factor 1 (HIF-1) plays a key role in the reprogramming of cancer metabolism by activating transcription of genes encoding glucose transporters and glycolytic enzymes, which take up glucose and convert it to lactate; pyruvate dehydrogenase kinase 1, which shunts pyruvate away from the mitochondria; and BNIP3, which triggers selective mitochondrial autophagy. The shift from oxidative to glycolytic metabolism allows maintenance of redox homeostasis and cell survival under conditions of prolonged hypoxia. Many metabolic abnormalities in cancer cells increase HIF-1 activity. As a result, a feed-forward mechanism can be activated that drives HIF-1 activation and may promote tumor progression.

Metastatic cancer is characterized by reprogramming of cellular metabolism leading to increased uptake of glucose for use as both an anabolic and a catabolic substrate. Increased glucose uptake is such a reliable feature that it is utilized clinically to detect metastases by positron emission tomography using 18F-fluorodeoxyglucose (FDG-PET) with a sensitivity of >90% [1]. As with all aspects of cancer biology, the details of metabolic reprogramming differ widely among individual tumors. However, the role of specific signaling pathways and transcription factors in this process is now understood in considerable detail. This review will focus on the involvement of hypoxia-inducible factor 1 (HIF-1) in both mediating metabolic reprogramming and responding to metabolic alterations. The placement of HIF-1 both upstream and downstream of cancer metabolism results in a feed-forward mechanism that may play a major role in the development of the invasive, metastatic, and lethal cancer phenotype.

O2 concentrations are significantly reduced in many human cancers compared with the surrounding normal tissue. The median PO2 in breast cancers is 10 mmHg, as compared with65 mmHg in normal breast tissue. Reduced O2 availability induces HIF-1, which regulates the transcription of hundreds of genes that encode proteins involved in every aspect of cancer biology, including: cell immortalization and stem cell maintenance; genetic instability; glucose and energy metabolism; vascularization; autocrine growth factor signaling; invasion and metastasis; immune evasion; and resistance to chemotherapy and radiation therapy.

HIF-1 is a transcription factor that consists of an O2 regulated HIF-1a and a constitutively expressed HIF-1b subunit. In well-oxygenated cells, HIF-1a is hydroxylated on proline residue 402 (Pro-402) and/or Pro-564 by prolyl hydroxylase domain protein 2 (PHD2), which uses O2 and a-ketoglutarate as substrates in a reaction that generates CO2 and succinate as byproducts. Prolylhydroxylated HIF-1a is bound by the von Hippel–Lindau tumor suppressor protein (VHL), which recruits an E3-ubiquitin ligase that targets HIF-1a for proteasomal degradation (Figure 1a). Asparagine 803 in the transactivation domain is hydroxylated in well-oxygenated cells by factor inhibiting HIF-1 (FIH-1), which blocks the binding of the coactivators p300 and CBP. Under hypoxic conditions, the prolyl and asparaginyl hydroxylation reactions are inhibited by substrate (O2) deprivation and/or the mitochondrial generation of reactive oxygen species (ROS), which may oxidize Fe(II) present in the catalytic center of the hydroxylases.

The finding that acute changes in PO2 increase mitochondrial ROS production suggests that cellular respiration is optimized at physiological PO2 to limit ROS generation and that any deviation in PO2 – up or down – results in increased ROS generation. If hypoxia persists, induction of HIF-1 leads to adaptive mechanisms to reduce ROS and re-establish homeostasis, as described below. Prolyl and asparaginyl hydroxylation provide a molecular mechanism by which changes in cellular oxygenation can be transduced to the nucleus as changes in HIF-1 activity.

HIF-1: upstream and downstream of cancer metabolism

Gregg L Semenza
Current Opinion in Genetics & Development 2010, 20:51–56

This review comes from a themed issue on Genetic and cellular mechanisms of oncogenesis Edited by Tony Hunter and Richard Marais

http://dx.doi.org:/10.1016/j.gde.2009.10.009

Hypoxia-inducible factor 1 (HIF-1) regulates the transcription of many genes involved in key aspects of cancer biology, including immortalization, maintenance of stem cell pools, cellular dedifferentiation, genetic instability, vascularization, metabolic reprogramming, autocrine growth factor signaling, invasion/metastasis, and treatment failure. In animal models, HIF-1 overexpression is associated with increased tumor growth, vascularization, and metastasis, whereas HIF-1 loss-of-function has the opposite effect, thus validating HIF-1 as a target. In further support of this conclusion, immunohistochemical detection of HIF-1a overexpression in biopsy sections is a prognostic factor in many cancers. A growing number of novel anticancer agents have been shown to inhibit HIF-1 through a  variety of molecular mechanisms. Determining which combination of drugs to administer to any given patient remains a major obstacle to improving cancer treatment outcomes.

Intratumoral hypoxia The majority of locally advanced solid tumors contain regions of reduced oxygen availability. Intratumoral hypoxia results when cells are located too far from a functional blood vessel for diffusion of adequate amounts of O2 as a result of rapid cancer cell proliferation and the formation of blood vessels that are structurally and functionally abnormal. In the most extreme case, O2 concentrations are below those required for survival, resulting in cell death and establishing a selection for cancer cells in which apoptotic pathways are inactivated, anti-apoptotic pathways are activated, or invasion/metastasis pathways that promote escape from the hypoxic microenvironment are activated. This hypoxic adaptation may arise by alterations in gene expression or by mutations in the genome or both and is associated with reduced patient survival.

Hypoxia-inducible factor 1 (HIF-1) The expression of hundreds of genes is altered in each cell exposed to hypoxia. Many of these genes are regulated by HIF-1. HIF-1 is a heterodimer formed by the association of an O2-regulated HIF1a subunit with a constitutively expressed HIF-1b subunit. The structurally and functionally related HIF-2a protein also dimerizes with HIF-1b and regulates an overlapping battery of target genes. Under nonhypoxic conditions, HIF-1a (as well as HIF-2a) is subject to O2-dependent prolyl hydroxylation and this modification is required for binding of the von Hippel–Lindau tumor suppressor protein (VHL), which also binds to Elongin C and thereby recruits a ubiquitin ligase complex that targets HIF-1a for ubiquitination and proteasomal degradation. Under hypoxic conditions, the rate of hydroxylation and ubiquitination declines, resulting in accumulation of HIF-1a. Immunohistochemical analysis of tumor biopsies has revealed high levels of HIF-1a in hypoxic but viable tumor cells surrounding areas of necrosis.

Genetic alterations in cancer cells increase HIF-1 activity In the majority of clear-cell renal carcinomas, VHL function is lost, resulting in constitutive activation of HIF-1. After re-introduction of functional VHL, renal carcinoma cell lines are no longer tumorigenic, but can be made tumorigenic by expression of HIF2a in which the prolyl residues that are subject to hydroxylation have been mutated. In addition to VHL loss-of-function, many other genetic alterations that inactivate tumor suppressors

Evaluation of HIF-1 inhibitors as anticancer agents

Gregg L. Semenza
Drug Discovery Today Oct 2007; 12(19/20).
http://dx.doi.org:/10.1016/j.drudis.2007.08.006

Hypoxia-inducible factor-1 (HIF-1), which is present at high levels in human tumors, plays crucial roles in tumor promotion by upregulating its target genes, which are involved in anaerobic energy metabolism, angiogenesis, cell survival, cell invasion, and drug resistance. Therefore, it is apparent that the inhibition of HIF-1 activity may be a strategy for treating cancer. Recently, many efforts to develop new HIF-1-targeting agents have been made by both academic and pharmaceutical industry laboratories. The future success of these efforts will be a new class of HIF-1-targeting anticancer agents, which would improve the prognoses of many cancer patients. This review focuses on the potential of HIF-1 as a target molecule for anticancer therapy, and on possible strategies to inhibit HIF-1 activity. In addition, we introduce YC-1 as a new anti-HIF-1, anticancer agent. Although YC-1 was originally developed as a potential therapeutic agent for thrombosis and hypertension, recent studies demonstrated that YC-1 suppressed HIF-1 activity and vascular endothelial growth factor expression in cancer cells. Moreover, it halted tumor growth in immunodeficient mice without serious toxicity during the treatment period. Thus, we propose that YC-1 is a good lead compound for the development of new anti-HIF-1, anticancer agents.

Although many anticancer regimens have been introduced to date, their survival benefits are negligible, which is the reason that a more innovative treatment is required. Basically, the identification of the specific molecular features of tumor promotion has allowed for rational drug discovery in cancer treatment, and drugs have been screened based upon the modulation of specific molecular targets in tumor cells. Target-based drugs should satisfy the following two conditions.

First, they must act by a described mechanism.

Second, they must reduce tumor growth in vivo, associated with this mechanism.

Many key factors have been found to be involved in the multiple steps of cell growth signal-transduction pathways. Targeting these factors offers a strategy for preventing tumor growth; for example, competitors or antibodies blocking ligand–receptor interaction, and receptor tyrosine kinase inhibitors, downstream pathway inhibitors (i.e., RAS farnesyl transferase inhibitors, mitogen-activated protein kinase and mTOR inhibitors), and cell-cycle arresters (i.e., cyclin-dependent kinase inhibitors) could all be used to inhibit tumor growth.

In addition to the intracellular events, tumor environmental factors should be considered to treat solid tumors. Of these, hypoxia is an important cancer-aggravating factor because it contributes to the progression of a more malignant phenotype, and to the acquisition of resistance to radiotherapy and chemotherapy. Thus, transcription factors that regulate these hypoxic events are good targets for anticancer therapy and in particular HIF-1 is one of most compelling targets. In this paper, we introduce the roles of HIF-1 in tumor promotion and provide a summary of new anticancer strategies designed to inhibit HIF-1 activity.

New anticancer strategies targeting HIF-1

Eun-Jin Yeo, Yang-Sook Chun, Jong-Wan Park
Biochemical Pharmacology 68 (2004) 1061–1069
http://dx.doi.org:/10.1016/j.bcp.2004.02.040

Classical work in tumor cell metabolism focused on bioenergetics, particularly enhanced glycolysis and suppressed oxidative phosphorylation (the ‘Warburg effect’). But the biosynthetic activities required to create daughter cells are equally important for tumor growth, and recent studies are now bringing these pathways into focus. In this review, we discuss how tumor cells achieve high rates of nucleotide and fatty acid synthesis, how oncogenes and tumor suppressors influence these activities, and how glutamine metabolism enables macromolecular synthesis in proliferating cells.

Otto Warburg’s demonstration that tumor cells rapidly use glucose and convert the majority of it to lactate is still the most fundamental and enduring observation in tumor metabolism. His work, which ushered in an era of study on tumor metabolism focused on the relationship between glycolysis and cellular bioenergetics, has been revisited and expanded by generations of tumor biologists. It is now accepted that a high rate of glucose metabolism, exploited clinically by 18FDGPET scanning, is a metabolic hallmark of rapidly dividing cells, correlates closely with transformation, and accounts for a significant percentage of ATP generated during cell proliferation. A ‘metabolic transformation’ is required for tumorigenesis. Research over the past few years has reinforced this idea, revealing the conservation of metabolic activities among diverse tumor types, and proving that oncogenic mutations can promote metabolic autonomy by driving nutrient uptake to levels that often exceed those required for cell growth and proliferation.

In order to engage in replicative division, a cell must duplicate its genome, proteins, and lipids and assemble the components into daughter cells; in short, it must become a factory for macromolecular biosynthesis. These activities require that cells take up extracellular nutrients like glucose and glutamine and allocate them into metabolic pathways that convert them into biosynthetic precursors (Figure 1). Tumor cells can achieve this phenotype through changes in the expression of enzymes that determine metabolic flux rates, including nutrient transporters and enzymes [8– 10]. Current studies in tumor metabolism are revealing novel mechanisms for metabolic control, establishing which enzyme isoforms facilitate the tumor metabolic phenotype, and suggesting new targets for cancer therapy.

The ongoing challenge in tumor cell metabolism is to understand how individual pathways fit together into the global metabolic phenotype of cell growth. Here we discuss two biosynthetic activities required by proliferating tumor cells: production of ribose-5 phosphate for nucleotide biosynthesis and production of fatty acids for lipid biosynthesis. Nucleotide and lipid biosynthesis share three important characteristics.

  • First, both use glucose as a carbon source.
  • Second, both consume TCA cycle intermediates, imposing the need for a mechanism to replenish the cycle.
  • Third, both require reductive power in the form of NADPH.

In this Essay, we discuss the possible drivers, advantages, and potential liabilities of the altered metabolism of cancer cells (Figure 1, not shown). Although our emphasis on the Warburg effect reflects the focus of the field, we would also like to encourage a broader approach to the study of cancer metabolism that takes into account the contributions of all interconnected small molecule pathways of the cell.

The Tumor Microenvironment Selects for Altered Metabolism One compelling idea to explain the Warburg effect is that the altered metabolism of cancer cells confers a selective advantage for survival and proliferation in the unique tumor microenvironment. As the early tumor expands, it outgrows the diffusion limits of its local blood supply, leading to hypoxia and stabilization of the hypoxia-inducible transcription factor, HIF. HIF initiates a transcriptional program that provides multiple solutions to hypoxic stress (reviewed in Kaelin and Ratcliffe, 2008). Because a decreased dependence on aerobic respiration becomes advantageous, cell metabolism is shifted toward glycolysis by the increased expression of glycolytic enzymes, glucose transporters, and inhibitors of mitochondrial metabolism. In addition, HIF stimulates angiogenesis (the formation of new blood vessels) by upregulating several factors, including most prominently vascular endothelial growth factor (VEGF).

Blood vessels recruited to the tumor microenvironment, however, are disorganized, may not deliver blood effectively, and therefore do not completely alleviate hypoxia (reviewed in Gatenby and Gillies, 2004). The oxygen levels within a tumor vary both spatially and temporally, and the resulting rounds of fluctuating oxygen levels potentially select for tumors that constitutively upregulate glycolysis. Interestingly, with the possible exception of tumors that have lost the von Hippel-Lindau protein (VHL), which normally mediates degradation of HIF, HIF is still coupled to oxygen levels, as evident from the heterogeneity of HIF expression within the tumor microenvironment. Therefore, the Warburg effect—that is, an uncoupling of glycolysis from oxygen levels—cannot be explained solely by upregulation of HIF. Other molecular mechanisms are likely to be important, such as the metabolic changes induced by oncogene activation and tumor suppressor loss.

Oncogene Activation Drives Changes in Metabolism Not only may the tumor microenvironment select for a deranged metabolism, but oncogene status can also drive metabolic changes. Since Warburg’s time, the biochemical study of cancer metabolism has been overshadowed by efforts to identify the mutations that contribute to cancer initiation and progression. Recent work, however, has demonstrated that the key components of the Warburg effect—

  • increased glucose consumption,
  • decreased oxidative phosphorylation, and
  • accompanying lactate production—
  • are also distinguishing features of oncogene activation.

The signaling molecule Ras, a powerful oncogene when mutated, promotes glycolysis (reviewed in Dang and Semenza, 1999; Ramanathan et al., 2005). Akt kinase, a well-characterized downstream effector of insulin signaling, reprises its role in glucose uptake and utilization in the cancer setting (reviewed in Manning and Cantley, 2007), whereas the Myc transcription factor upregulates the expression of various metabolic genes (reviewed in Gordan et al., 2007). The most parsimonious route to tumorigenesis may be activation of key oncogenic nodes that execute a proliferative program, of which metabolism may be one important arm. Moreover, regulation of metabolism is not exclusive to oncogenes.

Cancer Cell Metabolism: Warburg & Beyond

Hsu PP & Sabatini DM
Cell  Sep 5, 2008; 134, 703-705
http://dx.doi.org:/10.1016/j.cell.2008.08.021

Tumor cells respond to growth signals by the activation of protein kinases, altered gene expression and significant modifications in substrate flow and redistribution among biosynthetic pathways. This results in a proliferating phenotype with altered cellular function. These transformed cells exhibit unique anabolic characteristics, which includes increased and preferential utilization of glucose through the non-oxidative steps of the pentose cycle for nucleic acid synthesis but limited de novo fatty  acid   synthesis   and   TCA   cycle   glucose   oxidation. This  primarily nonoxidative anabolic profile reflects an undifferentiated highly proliferative aneuploid cell phenotype and serves as a reliable metabolic biomarker to determine cell proliferation rate and the level of cell transformation/differentiation in response to drug treatment.

Novel drugs effective in particular cancers exert their anti-proliferative effects by inducing significant reversions of a few specific non-oxidative anabolic pathways. Here we present evidence that cell transformation of various mechanisms is sustained by a unique disproportional substrate distribution between the two branches of the pentose cycle for nucleic acid synthesis, glycolysis and the TCA cycle for fatty acid synthesis and glucose oxidation. This can be demonstrated by the broad labeling and unique specificity of [1,2-13C2]glucose to trace a large number of metabolites in the metabolome. Stable isotope-based dynamic metabolic profiles (SIDMAP) serve the drug discovery process by providing a powerful new tool that integrates the metabolome into a functional genomics approach to developing new drugs. It can be used in screening kinases and their metabolic targets, which can therefore be more efficiently characterized, speeding up and improving drug testing, approval and labeling processes by saving trial and error type study costs in drug testing.

Metabolic Biomarker and Kinase Drug Target Discovery in Cancer Using Stable Isotope-Based Dynamic Metabolic Profiling (SIDMAP)

László G. Boros, Daniel J. Brackett and George G. Harrigan
Current Cancer Drug Targets, 2003, 3, 447-455 447

Pyruvate constitutes a critical branch point in cellular carbon metabolism. We have identified two proteins, Mpc1 and Mpc2, as essential for mitochondrial pyruvate transport in yeast, Drosophila, and humans. Mpc1 and Mpc2 associate to form an ~150 kilodalton complex in the inner mitochondrial membrane. Yeast and Drosophila mutants lacking MPC1 display impaired pyruvate metabolism, with an accumulation of upstream metabolites and a depletion of tricarboxylic acid cycle intermediates. Loss of yeast Mpc1 results in defective mitochondrial pyruvate uptake, while silencing of MPC1 or MPC2 in mammalian cells impairs pyruvate oxidation. A point mutation in MPC1 provides resistance to a known inhibitor of the mitochondrial pyruvate carrier. Human genetic studies of three families with children suffering from lactic acidosis and hyperpyruvatemia revealed a causal locus that mapped to MPC1, changing single amino acids that are conserved throughout eukaryotes. These data demonstrate that Mpc1 and Mpc2 form an essential part of the mitochondrial pyruvate carrier.

A Mitochondrial Pyruvate Carrier Required for Pyruvate Uptake in Yeast, Drosophila , and Humans

Daniel K. Bricker, Eric B. Taylor, John C. Schell, Thomas Orsak, et al.
Science Express 24 May 2012
http://dx.doi.org:/10.1126/science.1218099

Adenosine deaminase acting on RNA (ADAR) enzymes convert adenosine (A) to inosine (I) in double-stranded (ds) RNAs. Since Inosine is read as Guanosine, the biological consequence of ADAR enzyme activity is an A/G conversion within RNA molecules. A-to-I editing events can occur on both coding and non-coding RNAs, including microRNAs (miRNAs), which are small regulatory RNAs of ~20–23 nucleotides that regulate several cell processes by annealing to target mRNAs and inhibiting their translation. Both miRNA precursors and mature miRNAs undergo A-to-I RNA editing, affecting the miRNA maturation process and activity. ADARs can also edit 3′ UTR of mRNAs, further increasing the interplay between mRNA targets and miRNAs. In this review, we provide a general overview of the ADAR enzymes and their mechanisms of action as well as miRNA processing and function. We then review the more recent findings about the impact of ADAR-mediated activity on the miRNA pathway in terms of biogenesis, target recognition, and gene expression regulation.

Review ADAR Enzyme and miRNA Story: A Nucleotide that Can Make the Difference 

Sara Tomaselli, Barbara Bonamassa, Anna Alisi, Valerio Nobili, Franco Locatelli and Angela Gallo
Int. J. Mol. Sci. 19 Nov 2013; 14, 22796-22816 http://dx.doi.org:/10.3390/ijms141122796

The fermented wheat germ extract (FWGE) nutraceutical (Avemar™), manufactured under “good manufacturing practice” conditions and, fulfilling the self-affirmed “generally recognized as safe” status in the United States, has been approved as a “dietary food for special medical purposes for cancer patients” in Europe. In this paper, we report the adjuvant use of this nutraceutical in the treatment of high-risk skin melanoma patients. Methods: In a randomized, pilot, phase II clinical trial, the efficacy of dacarbazine (DTIC)-based adjuvant chemotherapy on survival parameters of melanoma patients was compared to that of the same treatment supplemented with a 1-year long administration of FWGE. Results: At the end of an additional 7-year-long follow-up period, log-rank analyses (Kaplan-Meier estimates) showed significant differences in both progression-free (PFS) and overall survival (OS) in favor of the FWGE group. Mean PFS: 55.8 months (FWGE group) versus 29.9 months (control group), p  0.0137. Mean OS: 66.2 months (FWGE group) versus 44.7 months (control group), p < 0.0298. Conclusions: The inclusion of Avemar into the adjuvant protocols of high-risk skin melanoma patients is highly recommended.

Adjuvant Fermented Wheat Germ Extract (Avemar™) Nutraceutical Improves Survival of High-Risk Skin Melanoma Patients: A Randomized, Pilot, Phase II Clinical Study with a 7-Year Follow-Up

LV Demidov, LV Manziuk, GY Kharkevitch, NA Pirogova, and EV Artamonova
Cancer Biotherapy & Radiopharmaceuticals 2008; 23(4)
http://dx.doi.org:/10.1089/cbr.2008.0486

Cancer cells possess unique metabolic signatures compared to normal cells, including shifts in aerobic glycolysis, glutaminolysis, and de novo biosynthesis of macromolecules. Targeting these changes with agents (drugs and dietary components) has been employed as strategies to reduce the complications associated with tumorigenesis. This paper highlights the ability of several food components to suppress tumor-specific metabolic pathways, including increased expression of glucose transporters, oncogenic tyrosine kinase, tumor-specific M2-type pyruvate kinase, and fatty acid synthase, and the detection of such effects using various metabonomic technologies, including liquid chromatography/mass spectrometry (LC/MS) and stable isotope-labeled MS. Stable isotope-mediated tracing technologies offer exciting opportunities for defining specific target(s) for food components. Exposures, especially during the early transition phase from normal to cancer, are critical for the translation of knowledge about food components into effective prevention strategies. Although appropriate dietary exposures needed to alter cellular metabolism remain inconsistent and/or ill-defined, validated metabonomic biomarkers for dietary components hold promise for establishing effective strategies for cancer prevention.

Bioactive Food Components and Cancer-Specific Metabonomic Profiles

Young S. Kim and John A. Milner
Journal of Biomedicine and Biotechnology 2011, Art ID 721213, 9 pages
http://dx.doi.org:/10.1155/2011/721213

This reviewer poses the following observation.  The importance of the pyridine nucleotide reduced/oxidized ratio has not been alluded to here, but the importance cannot be understated. It has relevance to the metabolic functions of anabolism and catabolism of the visceral organs.  The importance of this has ties to the pentose monophosphate pathway. The importance of the pyridine nucleotide transhydrogenase reaction remains largely unexplored.  In reference to the NAD-redox state, the observation was made by Nathan O. Kaplan that the organs may be viewed with respect to their primary functions in anabolic or high energy catabolic activities. Thus we find that the endocrine organs are largely tied to anabolic functioning, and to NADP, whereas cardiac and skeletal muscle are highly dependent on NAD. The consequence of this observed phenomenon appears to be related to a difference in the susceptibility to malignant transformation.  In the case of the gastrointestinal tract, the rate of turnover of the epithelium is very high. However, with the exception of the liver, there is no major activity other than cell turnover. In the case of the liver, there is a major commitment to synthesis of lipids, storage of fuel, and synthesis of proteins, which is largely anabolic, but there is also a major activity in detoxification, which is not.  In addition, the liver has a double circulation. As a result, a Zahn infarct is uncommon.  Now we might also consider the heart.  The heart is a muscle syncytium with a high need for oxygen.  Cutting of the oxygen supply makes the myocytes vulnerable to ischemic insult and abberant rhythm abnormalities.  In addition, the cardiomyocyte can take up lactic acid from the circulation for fuel, which is tied to the utilization of lactate from vigorous skeletal muscle activity.  The skeletal muscle is tied to glycolysis in normal function, which has a poor generation of ATP, so that the recycling of excess lactic acid is required by cardiac muscle and hepatocytes.  This has not been a part of the discussion, but this reviewer considers it important to remember in considering the organ-specific tendencies to malignant transformation.

Comment (Aurelian Udristioiu):

Otto Warburg observed that many cancers lose their capacity for mitochondrial respiration, limiting ATP production to anaerobic glycolytic pathways. The phenomenon is particularly prevalent in aggressive malignancies, most of which are also hypoxic [1].
Hypoxia induces a stochastic imbalance between the numbers of reduced mitochondrial species vs. available oxygen, resulting in increased reactive oxygen species (ROS) whose toxicity can lead to apoptotic cell death.
Mechanism involves inhibition of glycolytic ATP production via a Randle-like cycle while increased uncoupling renders cancers unable to produce compensatory ATP from respiration-.generation in the presence of intact tricarboxylic acid (TCA) enzyme.
One mitochondrial adaptation to increased ROS is over-expression of the uncoupling protein 2 (UCP2) that has been reported in multiple human cancer cell lines [2-3]. Increased UCP2 expression was also associated with reduced ATP production in malignant oxyphilic mouse leukemia and human lymphoma cell lines [4].
Hypoxia reduces the ability of cells to maintain their energy levels, because less ATP is obtained from glycolysis than from oxidative phosphorylation. Cells adapt to hypoxia by activating the expression of mutant genes in glycolysis.
-Severe hypoxia causes a high mutation rate, resulting in point mutations that may be explained by reduced DNA mismatch repairing activity.
The most direct induction of apoptosis caused by hypoxia is determined by the inhibition of the electron carrier chain from the inner membrane of the mitochondria. The lack of oxygen inhibits the transport of protons and thereby causes a decrease in membrane potential. Cell survival under conditions of mild hypoxia is mediated by phosphoinositide-3 kinase (PIK3) using severe hypoxia or anoxia, and then cells initiate a cascade of events that lead to apoptosis [5].
After DNA damage, a very important regulator of apoptosis is the p53 protein. This tumor suppressor gene has mutations in over 60% of human tumors and acts as a suppressor of cell division. The growth-suppressive effects of p53 are considered to be mediated through the transcriptional trans-activation activity of the protein. In addition to the maturational state of the clonal tumor, the prognosis of patients with CLL is dependent of genetic changes within the neoplastic cell population.

1.Warburg O. On the origin of cancer cells. Science 1956; 123 (3191):309-314
PubMed Abstract ; Publisher Full Text

2.Giardina TM, Steer JH, Lo SZ, Joyce DA. Uncoupling protein-2 accumulates rapidly in the inner mitochondrial membrane during mitochondrial reactive oxygen stress in macrophages. Biochim Biophys Acta 2008, 1777(2):118-129. PubMed Abstract | Publisher Full Text

3. Horimoto M, Resnick MB, Konkin TA, Routhier J, Wands JR, Baffy G. Expression of uncoupling protein-2 in human colon cancer. Clin Cancer Res 2004; 10 (18 Pt1):6203-6207. PubMed Abstract | Publisher Full Text

4. Randle PJ, England PJ, Denton RM. Control of the tricarboxylate cycle and it interactions with glycolysis during acetate utilization in rat heart. Biochem J 1970; 117(4):677-695. PubMed Abstract | PubMed Central Full Text

5. Gillies RJ, Robey I, Gatenby RA. Causes and consequences of increased glucose metabolism of cancers. J Nucl Med 2008; 49(Suppl 2):24S-42S. PubMed Abstract | Publisher Full Text

Shortened version of Comment –

Hypoxia induces a stochastic imbalance between the numbers of reduced mitochondrial species vs. available oxygen, resulting in increased reactive oxygen species (ROS) whose toxicity can lead to apoptotic cell death.
Mechanism involves inhibition of glycolytic ATP production via a Randle-like cycle while increased uncoupling renders cancers unable to produce compensatory ATP from respiration-.generation in the presence of intact tricarboxylic acid (TCA) enzyme.
One mitochondrial adaptation to increased ROS is over-expression of the uncoupling protein 2 (UCP2) that has been reported in multiple human cancer cell lines. Increased UCP2 expression was also associated with reduced ATP production in malignant oxyphilic mouse leukemia and human lymphoma cell lines.
Severe hypoxia causes a high mutation rate, resulting in point mutations that may be explained by reduced DNA mismatch repairing activity.

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Angiogenesis Inhibitors [9.5]

Writer and Curator: Larry H Bernstein, MD, FCAP

This article has the following structure:

9.5.1 Motesanib (AMG 706)

9.5.2 Drugs that block cancer blood vessel growth (anti angiogenics)

9.5.3 Recent Advances in Anti-Angiogenic Therapy of Cancer

9.5.4 Angiogenesis inhibitors in cancer therapy: mechanistic perspective on classification and treatment rationales

9.5.5 LUCITANIB a VEGFR/FGFR dual kinase inhibitor in Phase 2 trials

9.5.1 Motesanib (AMG 706)

by DR ANTHONY MELVIN CRASTO Ph.D

http://newdrugapprovals.org/2015/05/15/motesanib-amg-706/

Motesanib (AMG 706) is an experimental drug candidate originally developed by Amgen[1] but is now being investigated by theTakeda Pharmaceutical Company. It is an orally administered small molecule belonging to angiokinase inhibitor class which acts as an antagonist of VEGF receptorsplatelet-derived growth factor receptors, and stem cell factor receptors.[2] It is used as the phosphate salt motesanib diphosphate.

Motesanib, also known as AMG-706, is an orally administered multikinase inhibitor that selectively targets VEGF receptors, platelet-derived growth factor receptors, and Kit receptors.

N-(3,3-Dimethylindolin-6-yl){2-[(4-pyridylmethyl)amino](3-pyridyl)}carboxamide

motesanib-amg-706-a10608

motesanib-amg-706-a10608

http://www.adooq.com/media/catalog/product/cache/1/image/9df78eab33525d08d6e5fb8d27136e95/m/o/motesanib-amg-706-a10608.gif

http://www.chemblink.com/products/453562-69-1.htm

9.5.2 Drugs that block cancer blood vessel growth (anti angiogenics)

http://www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/biological/types/drugs-that-block-cancer-blood-vessel-growth

When it has reached 1 to 2mm across, a tumor needs to grow its own blood vessels in order to continue to get bigger. Some cancer cells make a protein called vascular endothelial growth factor (VEGF). The VEGF protein attaches to receptors on cells that line the walls of blood vessels within the tumour.

Drugs that block blood vessel growth factor

Some drugs block vascular endothelial growth factor (VEGF) from attaching to the receptors on the cells that line the blood vessels. This stops the blood vessels from growing.

A drug that blocks VEGF is bevacizumab (Avastin). It is also a monoclonal antibody.

Drugs that block signalling within the cell

Some drugs stop the VEGF receptors from sending growth signals into the blood vessel cells. These treatments are also called cancer growth blockers or tyrosine kinase inhibitors (TKIs).

Sunitinib (Sutent) is a type of TKI that blocks the growth signals inside blood vessel cells. It is used to treat kidney cancer and a rare type of stomach cancer called gastrointestinal stromal tumour (GIST).

Drugs that affect signals between cells

Some drugs act on the chemicals that cells use to signal to each other to grow. This can block the formation of blood vessels. Drugs that works in this way include thalidomide and lenalidomide (Revlimid).

Each drug has different side effects. You can look up the name of your drug in our cancer drug section to find out about the side effects you may have.

To find trials using anti angiogenesis treatment go to our clinical trials database and type ‘angiogenesis’ into the search box.

http://www.cancer.gov/about-cancer/treatment/types/immunotherapy/angiogenesis-inhibitors-fact-sheet

Tumors can cause their blood supply to form by giving off chemical signals that stimulate angiogenesis. Tumors can also stimulate nearby normal cells to produce angiogenesis signaling molecules. The resulting new blood vessels “feed” growing tumors with oxygen and nutrients, allowing the cancer cells to invade nearby tissue, to move throughout the body, and to form colonies of cancer cells, called metastases. Because tumors cannot grow beyond a certain size or spread without a blood supply, scientists are trying to find ways to block tumor angiogenesis.

Angiogenesis requires the binding of signaling molecules, such as vascular endothelial growth factor (VEGF), to receptors on the surface of normal endothelial cells. When VEGF and other endothelial growth factors bind to their receptors on endothelial cells, signals within these cells are initiated that promote the growth and survival of new blood vessels.

Angiogenesis inhibitors interfere with various steps in this process. For example, bevacizumab (Avastin®) is a monoclonal antibody that specifically recognizes and binds to VEGF (1). When VEGF is attached to bevacizumab, it is unable to activate the VEGF receptor. Other angiogenesis inhibitors, including sorafenib and sunitinib, bind to receptors on the surface of endothelial cells or to other proteins in the downstream signaling pathways, blocking their activities (2).

The U.S. Food and Drug Administration (FDA) has approved bevacizumab to be used alone forglioblastoma that has not improved with other treatments and to be used in combination with other drugs to treat metastatic colorectal cancer, some non-small cell lung cancers, and metastatic renal cell cancer. Bevacizumab was the first angiogenesis inhibitor that was shown to slow tumor growth and, more important, to extend the lives of patients with some cancers.

The FDA has approved other drugs that have antiangiogenic activity, including sorafenib (Nexavar®), sunitinib(Sutent®), pazopanib (Votrient®), and everolimus (Afinitor®). Sorafenib is approved for hepatocellular carcinoma and kidney cancer, sunitinib and everolimus for both kidney cancer and neuroendocrine tumors, and pazopanib for kidney cancer.

Angiogenesis inhibitors are unique cancer-fighting agents because they tend to inhibit the growth of blood vessels rather than tumor cells. In some cancers, angiogenesis inhibitors are most effective when combined with additional therapies, especially chemotherapy. It has been hypothesized that these drugs help normalize the blood vessels that supply the tumor, facilitating the delivery of other anticancer agents, but this possibility is still being investigated.

Angiogenesis inhibitor therapy does not necessarily kill tumors but instead may prevent tumors from growing. Therefore, this type of therapy may need to be administered over a long period.

Initially, it was thought that angiogenesis inhibitors would have mild side effects, but more recent studies have revealed the potential for complications that reflect the importance of angiogenesis in many normal body processes, such as wound healing, heart and kidney function, fetal development, and reproduction. Side effects of treatment with angiogenesis inhibitors can include problems with bleeding, clots in the arteries (with resultant stroke or heart attack), hypertension, and protein in the urine (35). Gastrointestinal perforation and fistulas also appear to be rare side effects of some angiogenesis inhibitors.

In addition to the angiogenesis inhibitors that have already been approved by the FDA, others that target VEGF or other angiogenesis pathways are currently being tested in clinical trials (research studies involving patients). If these angiogenesis inhibitors prove to be both safe and effective in treating human cancer, they may be approved by the FDA and made available for widespread use.

In addition, phase I and II clinical trials are testing the possibility of combining angiogenesis inhibitor therapy with other treatments that target blood vessels, such as tumor-vascular disrupting agents, which damage existing tumor blood vessels (6).

9.5.3 Recent Advances in Anti-Angiogenic Therapy of Cancer

Rajeev S. Samant and Lalita A. Shevde
Oncotarget. 2011 Mar; 2(3): 122–134.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3260813/

More than forty anti-angiogenic drugs are being tested in clinical trials all over the world. This review discusses agents that have approved by the FDA and are currently in use for treating patients either as single-agents or in combination with other chemotherapeutic agents.

Tumor angiogenesis is generation of a network of blood vessels within the cancerous growth. This process can occur two ways: The more accepted model involves the release of signaling molecules by the tumor cells; these molecules activate the surrounding tissue to promote growth of new blood vessels. This stimulates vascular endothelial cells to divide rapidly [910]. The other model proposes the generation of new vasculature by vasculogenic mimicry. This model argues that the tumor cells trans-differentiate in endothelial-like cells and create structures from inside of the tumor tapping into a nearby blood vessel [4].

Escape of the tumor cell from the confines of the primary tumor to distant body parts is the pre-requisite for hematogenous metastasis. This escape route is provided by the tumor vasculature. Thus, it was envisioned that inhibition of angiogenesis will also lead to inhibition of metastasis. This phenomenon was demonstrated by very elegant mouse model studies using angiostatin [1112]. Angiostatin was also demonstrated to be secreted by some primary tumors leading to restricted growth of the metastasis leading to “dormancy” of the metastasis. Mice deficient in angiogenesis (Id1 & Id3 deficient) showed significantly less tumor take rates [13]. Independent studies showed absence of metastasis in angiogenesis deficient mice [1415]. Defective angiogenesis was attributed to impaired VEGF-dependent recruitment of precursor endothelial cells from the bone marrow to the newly developing tumor vasculature [16].

Metastasis of malignant tumors to regional lymph nodes is one of the early signs of cancer spread in patients, and it occurs at least as frequently as hematogenous metastasis [17]. Particularly, in cancers, such as breast cancer, lymphatic metastasis is a predominant route for tumor spread. The contribution of lymphatic system to the tumor growth is an area that is relatively less studied. However, lymphatic vessels are speculated to contribute to tumor growth and metastasis in a variety of ways. The VEGF, FGF2 and PDGF produced by vascular endothelial cells are proposed to be involved in the activation of lymphatic endothelial cells, which in turn produce matrix metalloproteases and urokinase plasminogen activator (uPA) that can promote malignant tumor growth. Thus, there exists a synergistic crosstalk between the tumor and the lymphatic vessels and blood vessels.

Angiogenesis is a complex and intricately regulated process. Like all other regulated biological phenomena, angiogenesis has activators or pro-angiogenic factors and inhibitors or anti-angiogenic factors [9].

The Activators

Tumor cells activate signaling pathways that promote uncontrolled proliferation and survival. These include the PI3K/AKT/mTOR pathway, Hedgehog pathway and, Wnt pathway [1824] that produce pro-angiogenic signaling intermediates [2526]. Among the several reported activators of angiogenesis present in cells two proteins appear to be the most important for sustaining tumor growth: vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF). VEGF and bFGF are secreted by the tumor into the surrounding tissue. They bind to their cognate receptors on endothelial cells. This activates a signaling cascade that transmits a nuclear signal prompting target genes to activate endothelial cell growth. Activated endothelial cells also produce matrix metalloproteinases (MMPs). These MMPs break down the extracellular matrix and allow the migration of endothelial cells. The division and migration of the endothelial cells leads to formation of new blood vessels [2728].

The Inhibitors

If angiogenesis is so critical for the tumor growth, then agents that inhibit angiogenesis would have great therapeutic value. With the discovery of endostatin, the concept of anti-angiogenic therapy was launched and popularized by Dr. Folkman [29]. Angiogenesis inhibitors have been discovered from a variety of sources. Some are naturally present in the human body e.g. specific fragments of structural proteins such as collagen or plasminogen (angiostatin, endostatin, tumstatin) [30]. Others are natural products in green tea, soy beans, fungi, mushrooms, tree bark, shark tissues, snake venom etc. [31]. A plethora of synthetic compounds are also characterized to have anti-angiogenic properties [32].

ANTI-ANGIOGENIC TREATMENT OF CANCER

Since angiogenesis is an event critical to primary tumor growth as well as metastasis, anti-angiogenic treatment of tumors is a highly promising therapeutic avenue [33]. Thus, for over last couple of decades, there has been a robust activity aimed towards the discovery of angiogenesis inhibitors [3435]. More than forty anti-angiogenic drugs are being tested in human cancer patients in clinical trials all over the world. From the several anti-angiogenic agents reported, we have focused this review on discussing those agents that have received FDA approval in the United States and are currently in use for treating patients either as a single-agent or in combination with other chemotherapeutic agents (Figure ​(Figure1).1). Based on functionality, the anti-angiogenic drugs can be sub-divided into three main groups:

angiogenesis inhibitors oncotarget-02-122-g001

angiogenesis inhibitors oncotarget-02-122-g001

Figure 1

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3260813/bin/oncotarget-02-122-g001.jpg

Targets of FDA-approved angiogenesis inhibitors: Angiogenesis inhibitors impact both, the tumor as well as the endothelial cells resulting in the disruption of the effects of the microenvironment in promoting tumor growth and angiogenesis

Drugs that inhibit growth of endothelial cells

e.g. Endostatin and combretastatin A4, cause apoptosis of the endothelial cells [36]. Thalidomide is also a potent inhibitor of endothelial cell growth [37].

Drugs that block angiogenesis signaling

e.g. anti-VEGF antibodies (Avastin, FDA approved for colorectal cancer), Interferon-alpha (inhibits the production of bFGF and VEGF) [36].

Drugs that block extracellular matrix breakdown

e.g. inhibitors of MMPs [38].

ANTI-ANGIOGENIC THERAPIES THAT HAVE RECEIVED USA-FDA APPROVAL

Conventional chemotherapy is usually a systemic therapy that tries to capture a narrow therapeutic window offered by rapid proliferation of tumor cells compared to the normal cells. Chemotherapy has significant side effects such as hair loss, diarrhea, mouth ulcer, infection, and low blood counts. Anti-angiogenic therapy has several advantages over chemotherapy as it is mostly not directed towards directly killing cells but stopping the blood vessel formation, an event that is rare in tissues other than growing tumor. Hence it is well tolerated by the patients and has fewer side effects [29]. There are currently seven approved anti-cancer therapies in two primary categories:

  1. Monoclonal antibodies directed against specific pro-angiogenic growth factors and/or their receptors
  2. Small molecule tyrosine kinase inhibitors (TKIs) of multiple pro-angiogenic growth factor receptors.

Besides these, inhibitors of mTOR (mammalian target of rapamycin), proteasome inhibitors and thalidomide have also been reported to indirectly inhibit angiogenesis through mechanisms that are not completely understood.

MONOCLONAL ANTIBODY THERAPIES

Four monoclonal antibody therapies are approved to treat several tumor types:

Bevacizumab (Avastin®)

The first FDA approved angiogenesis inhibitor, Avastin is a humanized monoclonal antibody that binds biologically active forms of vascular endothelial growth factor (VEGF) and prevents its interaction with VEGF receptors (VEGFR-1 and VEGFR-2), thereby inhibiting endothelial cell proliferation and angiogenesis. Bevacizumab has been tested in phase I studies in combination with chemotherapy with a good safety profile [39]. This treatment is approved for metastatic colorectal cancer and non-small cell lung cancer [4043]. Bevacizumab has also evolved as a first line of treatment in combination with paclitaxel in breast cancer patients by virtue of its ability to double median progression-free survival (PFS) [44]. In combination with chemoendocrine therapy (including capecitabine and vinorelbine, and letrozole) bevacizumab treatment significantly decreased the percentage of viable circulating endothelial cells and prevented the chemotherapy-induced mobilization of circulating progenitors [45]. In combination with irinotecan, bevacizumab significantly increased PFS in glioma patients [4647]. VEGF has emerged as a compelling therapeutic target for leukemias. Inhibition of angiogenesis in hematological malignancies interdicts the angiogenesis within the bone marrow ecosystem comprised of multiple cell types, including fibroblasts, endothelial progenitor cells, endothelial cells, dendritic cells and, malignant cells, blocking the availability of nutrients to cancer cells and disrupting crosstalk between the various cell types to curtail the malignant phenotype [48].

Cetuximab (Erbitux®)

This is a monoclonal antibody that binds the extracellular domain of epidermal growth factor receptor (EGFR), preventing ligand binding and activation of the receptor resulting in internalization and degradation of the receptor culminating in inhibition of cell proliferation and angiogenesis. Cetuximab downregulated VEGF expression in a dose-dependent manner in a human colorectal carcinoma (CRC) cell line and in human CRC mouse xenografts [49]. The xenografts also showed a significant reduction in blood vessel counts following several rounds of cetuximab treatment [49], indicating that the tumor-promoting effects of EGFR overexpression may be mediated through VEGF stimulation and tumor angiogenesis. This treatment is approved for metastatic CRC and head and neck cancer [50] in patients who are refractory to irinotecan-based chemotherapy. In combination with irinotecan (an inhibitor of topoisomerase I), cetuximab is the first monoclonal antibody that has been approved by the FDA as second-line treatment for metastatic colorectal cancer [5152]. In Phase I and Phase III trials [5354] cetuximab significantly improved the effects of radiotherapy in patients with unresectable (cannot be removed by surgery) squamous cell carcinoma of the head and neck (SCCHN). Cetuximab has also been shown to sensitize cells to radiation and chemotherapy, potentially through blocking EGFR nuclear import and the associated activation of DNA protein kinase enzymes necessary for repairing radiation- and chemotherapy-induced DNA damage [55]. Compared to radiation alone, cetuximab plus radiation therapy can nearly double the median survival in patients with a certain kind of head and neck cancer that has not spread to other parts of the body [54] making cetuximab the only drug achieving interesting response rate in second line treatment of advanced SCCHN [56]. Cetuximab was also found to be tolerated well in combination with cisplatin, or carboplatin, and fluorouracil [5758].

Panitumumab (Vectibix™)

It is a fully humanized anti-EGFR monoclonal antibody that binds specifically to the human EGFR. Panitumumab is a recombinant human monoclonal antibody [59]; therefore, the risk of an infusion reaction is minimized. Vectibix® is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens [6062]. The effectiveness of Vectibix® as a single agent for the treatment of EGFR-expressing, metastatic CRC is based on progression-free survival [6364]. Panitumumab is used in patients who are not responding to regimens containing fluorouracil, oxaliplatin, and irinotecan [60]. Patients often receive panitumumab after receiving bevacizumab or cetuximab. Panitumumab can be given with FOLFOX (oxaliplatin, leucovorin, and fluorouracil) or FOLFIRI (irinotecan, leucovorin, and fluorouracil) regimens, or as a single agent. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix® in colon cancer [65]. This drug is also being tested for aerodigestive track and head and neck cancer [6667].

Trastuzumab (Herceptin®)

Is a humanized monoclonal antibody that binds the extracellular domain of HER-2, which is overexpressed in 25-30% of invasive breast cancer tumors [68]. HER2-positive breast cancer is highly aggressive disease with high recurrence rate, poorer prognosis with decreased survival compared with HER2-negative breast cancer [69]. Herceptin® is designed to target and block the function of HER2 protein overexpression. This is the first humanized antibody is approved for Breast cancer [70]. Herceptin® is approved by the FDA to treat HER2 positive breast cancer that has metastasized after treatment with other anticancer drugs [71]. It is also approved to be used with other drugs to treat HER2-positive breast cancer that has spread to the lymph nodes to be used after surgery. The FDA first approved Herceptin in September 1998 [7173]. In November 2006, the FDA approved Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel, for the adjuvant treatment of patients with HER2-positive, node-positive breast cancer (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm). In January 2008, the FDA approved Herceptin as a single agent for the adjuvant treatment of HER2-overexpressing node-negative (ER/PR-negative or with one high-risk feature) or node-positive breast cancer, following multi-modality anthracycline-based therapy (http://biopharminternational.findpharma.com/biopharm/News/FDA-Approves-Expanded-Adjuvant-Indications-for-Her/ArticleStandard/Article/detail/518867). Trastuzumab is also being studied in the treatment of other types of cancers such as pancreatic [74], endometrial [75], lung [76], cervical [77] and ovarian cancer [78]

SMALL MOLECULE TYROSINE KINASE INHIBITORS (TKIs)

Protein tyrosine kinases have emerged as crucial targets for therapeutic intervention in cancer especially because they play an important role in the modulation of growth factor signaling. As per ClinicalTrials.gov (www.clinicaltrials.gov), there are 43 ongoing studies on tyrosine kinase inhibitors in angiogenesis. Since discussing all of them is beyond the scope of this article, we have focused our discussion on the three TKIs that are currently approved as anti-cancer therapies:

Erlotinib (Tarceva®)

Erlotinib hydrochloride (originally coded as OSI-774) is an orally available, potent, reversible, and selective inhibitor of the EGFR (ErbB1) tyrosine kinase activity. Erlotinib hydrochloride has been approved by FDA for treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen [7980]. Interesting recent studies have demonstrated that since Erlotinib and Bevacizumab act on two different pathways critical to tumor growth and dissemination, administering these drugs concomitantly may confer additional clinical benefits to cancer patients with advanced disease. This combination therapy may prove to be a viable second-line alternative to chemotherapy in patients with NSCLC [81]. Also, for patients with locally advanced, unresectable or metastatic pancreatic carcinoma, Erlotinib has received FDA approval for the treatment in combination with gemcitabine [8283]. Erlotinib is also being studied in the treatment of other types of cancers. For example combination of Erlotinib with Bevacizumab has been evaluated in metastatic breast cancer [84], hepatocellular carcinoma [85] and in metastatic renal cancer [86] as phase II trials. Outcomes for prostate, cervical and colorectal cancers treated with Erlotinib are cautiously optimistic [8789].

Sorafenib (Nexavar®)

Sorafenib is an orally active inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-β, and Raf-1 tyrosine kinase activity [90]. It has received the approval of FDA for the treatment of patients with unresectable hepatocellular carcinoma [91] and advanced renal cell carcinoma [92]. However, not all advanced hepatocellular carcinoma patients were able to tolerate sorafenib and some patients experienced tumor progression [91]. Sorafenib has shown improvements in PFS in patients with renal cell carcinoma [93]. It is one of the aggressively studied drugs. According to the NCI clinical trials search results, there are about 168 active clinical trials involving sorafenib in a variety of cancers.

Sunitinib (Sutent®)

Sunitinib targets activity of multiple tyrosine kinases such as VEGFR-1, VEGFR-2, VEGFR-3, PDGFR- β, and RET [94]. It is approved by FDA as Sunitinib malate for treating advanced (metastatic) renal cell carcinoma [95]. It is also approved by FDA for gastrointestinal stromal tumor (GIST) in patients whose disease has progressed or who are unable to tolerate treatment with imatinib (Gleevec), the current treatment for GIST patients [9596]. Sunitinib has shown early evidence of anti-tumor activity in Phase II trials in US, European and Asian patients with locally advanced, unresectable and metastatic hepatocellular carcinoma. A Phase III trial of sunitinib in hepatocellular carcinoma is ongoing [97]. According to the NCI clinical trials search results, Sunitinib is currently evaluated in about 150 active clinical trials. It is evaluated for ovarian [98], breast [99] and non small cell lung cancer [100] among others [101].

Inhibitors of mTOR

mTOR plays a part in the PI3 kinase/AKT pathway involved in tumor cell proliferation and angiogenesis [102]. Rapamycin and related mTOR inhibitors inhibit endothelial cell VEGF expression, as well as VEGF-induced endothelial cell proliferation [103]. Inhibitors of mTOR are an important class of anti-angiogenic agents. These include: deforolimus, everolimus, rapamycin (sirolimus), and temsirolimus [104105]. Temsirolimus (Toricel™) is a small molecule inhibitor of mTOR, approved for treating advanced renal cell carcinoma [106]. It is a type of rapamycin analog and a type of serine/threonine kinase inhibitor, it is also called CCI-779. In pre-clinical models combination therapy for treating breast cancer using anti-estrogen, ERA-923, and temsirolimus has been successfully tested [107]. It is found to be highly effective against human melanoma when tested in combination with cisplatin and DTIC (in independent studies) in a SCID mouse xenotranplantation model [108109]. There are over 41 active studies of Temsirolimus for a variety of solid tumors [110]. mTOR inhibition has also been strongly advocated in as a putative cancer therapeutic strategy for urologic malignancies [111]. In a pilot study (6 patients) with imatinib-resistant CML, rapamycin induced major and minor leukocyte responses, with an observed decrease in the mRNA levels of VEGFA in circulating leukaemic cells [112]. Combination treatments for breast cancer with aromatase inhibitor [113] and letrozol [114] are also being evaluated. Rapamycin treatment brought partial responses (>50% reduction in the absolute number of blood blasts) and stable disease in adult refractory/relapsed AML [115]. In a recent report, Deforolimus was studied in a Phase 2 trial in pretreated patients with various hematological malignancies, including ALL, AML, CLL, CML, MDS, agnogenic myeloid metaplasia, mantle cell lymphoma and T-cell leukemia/lymphoma [116]. Overall, 40% of deforolimus-treated patients experienced hematological improvement or stable disease.

OTHER ANGIOGENIC AGENTS

Bortezomib (Velcade®)

Is a proteasome inhibitor that disrupts signaling of cancer cells, leading to cell death and tumor regression. It is the first compound in its class to be used in clinical practice. It has indirect anti-angiogenic properties [117]. While its exact mechanism is not understood, it induces the pro-apoptotic BH3-only family member NOXA in a p53 independent fashion triggering of a caspase cascade culminating in apoptosis in melanoma and myeloma cells [118]. It is FDA-approved for the treatment of myeloma that has relapsed after two prior treatments (or where resistance has developed following the last treatment). It was also found to induce high quality responses as third line salvage therapy with acceptable toxicity in a significant proportion of homogeneously pre-treated myeloma patients with progressive disease after autologous transplantation and thalidomide. [119]. In a Phase 3 trial involving 669 myeloma patients treated with at least one prior therapy, bortezomib increased median, improved overall survival, and increased response rate, compared with high-dose dexamethasone [120]. In combination with doxorubicin and gemcitabine, bortezomib was also found to be effective in heavily pretreated, advanced Cutaneous T cell Lymphomas (CTCL) [121]. Bortezomib was also reported to be active as a single agent for patients with relapsed/refractory CTCL and Peripheral T Cell Lymphoma (PTCL) with skin involvement [122]. On the contrary, the use of bortezomib was discouraged after a phase II study revealed that found in combination with dexamethasone, bortezomib is not active in heavily pre-treated patients with relapsed Hodgkin’s lymphoma [123124].

Thalidomide (Thalomid®)

Possesses immunomodulatory, anti-inflammatory, and anti-angiogenic properties, although the precise mechanisms of action are not fully understood. Thalidomide was the first angiogenesis inhibitor to demonstrate clinical efficacy in multiple myeloma [37125]. Specifically in myeloma, thalidomide down-regulated VEGF secretion from bone marrow endothelial cells obtained from patients with active disease. In a landmark Phase 2 clinical trial, 169 previously treated patients with refractory myeloma received thalidomide monotherapy [126]. Partial response, was achieved in 30% of patients, and 14% achieved a complete or nearly complete remission. The survival rate at 2 years was 48%. These results led to many subsequent clinical studies of thalidomide in myeloma, leading ultimately to FDA approval of the drug in 2006, for the treatment of newly diagnosed multiple myeloma, in combination with dexamethasone. In the pivotal Phase 3 trial, the response rate in patients receiving thalidomide plus dexamethasone was 63% compared to 41% with dexamethasone alone [127]. Long-term outcome measures, including time-to-progression (TTP) and PFS, were recently reported for a 470 patient randomized, placebo-controlled Phase 3 clinical trial of a similar protocol in newly diagnosed multiple myeloma, with comparable overall response rates [128]. Significant increases resulted in both median TTP and median PFS for the thalidomide plus dexamethasone group versus dexamethasone alone.

Thalidomide was found to be moderately tolerated and minimally effective in patients with histologically proven advanced hepatocellular carcinoma [129]. Thalidomide provided no survival benefit for patients with multiple, large, or midbrain metastases when combined with WBRT (whole-brain radiation therapy) [130]. On the contrary, thalidomide did not significantly add to the efficacy of the fludarabine, carboplatin, and topotecan (FCT) regimen in poor prognosis AML patients [131] and was also ineffective in improving prognosis or decreasing plasma VEGF levels in patients with persistent or recurrent leiomyosarcoma of the uterus [132].

METRONOMIC THERAPY

While conventional anti-angiogenic therapy is based on Maximum Tolerated Doses (MTD), the cells involved in angiogenesis may regenerate during the three- to four-week interval between cycles of the chemotherapy. Taking advantage of the fact that endothelial cells are about 10–100 times more susceptible to chemotherapeutic agents than cancer cells, therapy based on daily, oral, low-dose chemotherapeutic drugs was designed. Metronomic chemotherapy refers to the close, rhythmic administration of low doses of cytotoxic drugs, with minimal or no drug-free breaks, over prolonged periods. Metronomic therapy appears promising mainly due to the fact that its anti-angiogenic and anti-tumorigenic effects are accompanied by low toxicity, limited side effects, no need for hospitalization and allowing for feasible combinations with selective inhibitors of angiogenesis. There are several foreseeable advantages and opportunities for metronomic chemotherapy: activity against the parenchymal and stromal components, pro-apoptotic activity, reduction of the likelihood of emergence of acquired resistance, feasibility of long term administration and acceptable systemic side effects [133]. In a pilot phase II study conducted by Correale et al [134] to investigate the toxicity and activity of the novel metronomic regimen of weekly cisplatin and oral etoposide in high-risk patients with NSCLC, the objective response rate was 45.2%, disease control was 58.1%, meantime to progression and survival were 9 and 13 months, respectively. Pharmacokinetic analysis showed that this regimen allowed a greater median monthly area under the curve of the drugs than conventional schedules. In a Phase I trial of metronomic dosing of docetaxel and thalidomide, of the 26 patients with advanced tumors enrolled, prolonged freedom from disease progression was observed in 44.4% of the evaluable patients [135].

Circulating endothelial progenitor cells (EPCs) also participate in tumor angiogenesis. In a study comparing the effects of metronomic chemotherapy over conventional dose-dense chemotherapy, it was found that the numbers of circulating EPCs and the plasma levels of VEGF increased sharply, doubling pre-therapeutic levels at day 21 after conventional chemotherapy, whereas under low-dose metronomic chemotherapy, the numbers of circulating EPCs decreased significantly and VEGF plasma concentrations remained unchanged. These observations provide evidence that conventional dose-dense chemotherapy leads to rebound EPC mobilization even when given with adjuvant intention, while low-dose metronomic scheduling of cytotoxic substances such as trofosfamide may sharply reduce EPC release into the circulation. [136].

Combined bevacizumab and metronomic oral cyclophosphamide was also discovered to be a safe and effective regimen for heavily pre-treated ovarian cancer patients [137]. Treatment with metronomic capecitabine and cyclophosphamide in combination with bevacizumab was shown to be effective in advanced breast cancer and additionally was minimally toxic [138]. Metronomic treatment with carboplatin and vincristine associated with fluvastatin and thalidomide significantly increased survival of pediatric brain stem tumor patients. Tumor volume showed a significant reduction accompanied by increased quality of life [139]. Thus, given the fact that the most evident effect of selective anti-angiogenic agents (i.e. bevacizumab) is the significant prolonging of the duration of response obtainable by chemotherapy alone, with minimal possible side effects of cytotoxic agents given in association metronomic chemotherapy should be considered both as novel up-front or maintenance treatment in patients with biologically poorly aggressive advanced cancer diseases [140].

Overall, metronomic chemotherapy was able to induce tumor stabilization and prolong the duration of clinical benefit, without much associated toxicity. Emerging evidence suggests that metronomic chemotherapy could also activate the host immune system and potentially induce tumor dormancy [141143].

CONCLUSIONS AND FUTURE PERSPECTIVES

While angiogenesis as a hallmark of tumor development and metastasis is now a validated target for cancer treatment, the overall benefits of anti-angiogenic drugs from the perspective of impacting survival have left much to desire, endorsing a need for developing more effective therapeutic regimens e.g., combining anti-angiogenic drugs with established chemotherapeutic drugs [144145]. There are now several agents that target the tumor vasculature through different pathways, either by inhibiting formation of the tumor neovasculature or by directly targeting the mature tumor vessels. The main body of evolving evidence suggests that their effects are compounded by their synergistic use with conventional chemotherapy rather than individual agents. Anti-angiogenic drugs such as bevacizumab can bring about a transient functional normalization of the tumor vasculature. This can have an additive effect when co-administered with chemo/radiotherapy. But long term inhibition of angiogenesis reduces tumor uptake of co-administered chemotherapeutic agents. This underscores the need for discovering new targets for anti-angiogenic therapy in order to effectively prohibit angiogenesis and circumvent mechanisms that contribute to resistance mechanisms that emerge with long term use of anti-angiogenic therapies. It also warrants a need to define reliable surrogate indicators of effectiveness of the anti-angiogenic therapy as well as dependable markers for identifying the patients who are most likely to benefit from the combination of anti-angiogenic therapy and conventional chemotherapy.

Several new frontiers are emerging. New advances in understanding endothelial cells, which constitute the tumor vasculature, towards developing antiangiogenic strategies are one of the important ones [146147]. Novel cellular targets such as integrins and microRNAs and novel treatment options such as possible use of pharmaconutrients to modulate angiogenic pathways need careful testing and evaluation [148151]. Finally, the administration of these drugs in a metronomic schedule is likely to improve the overall response to anti-angiogenic drugs making it feasible to administer them with conventionally toxic chemotherapeutic drugs, thus increasing the armamentarium of drug combinations that can be employed for treatment.

9.5.4 Angiogenesis inhibitors in cancer therapy: mechanistic perspective on classification and treatment rationales

El-Kenawi AE1, El-Remessy AB.
Br J Pharmacol. 2013 Oct; 170(4):712-29.
http://dx.doi.org:/10.1111/bph.12344

Angiogenesis, a process of new blood vessel formation, is a prerequisite for tumor growth to supply the proliferating tumor with oxygen and nutrients. The angiogenic process may contribute to tumour progression, invasion and metastasis, and is generally accepted as an indicator of tumor prognosis. Therefore, targeting tumor angiogenesis has become of high clinical relevance. The current review aimed to highlight mechanistic details of anti-angiogenic therapies and how they relate to classification and treatment rationales. Angiogenesis inhibitors are classified into either direct inhibitors that target endothelial cells in the growing vasculature or indirect inhibitors that prevent the expression or block the activity of angiogenesis inducers. The latter class extends to include targeted therapy against oncogenes, conventional chemotherapeutic agents and drugs targeting other cells of the tumor micro-environment. Angiogenesis inhibitors may be used as either monotherapy or in combination with other anticancer drugs. In this context, many preclinical and clinical studies revealed higher therapeutic effectiveness of the combined treatments compared with individual treatments. The proper understanding of synergistic treatment modalities of angiogenesis inhibitors as well as their wide range of cellular targets could provide effective tools for future therapies of many types of cancer.

Two major processes of blood vessel formation are implicated in the development of vascular system: vasculogenesis and angiogenesis. Vasculogenesis prevails in the embryo and refers to the formation ofde novo blood vessels by in situ differentiation of the mesoderm-derived angioblasts and endothelial precursors. Angiogenesis is the formation of new capillaries from pre-existing vessels and circulating endothelial precursors (Polverini, 2002; Chung et al., 2010; Ribatti and Djonov, 2012). Angiogenesis is a tightly controlled dynamic process that can occur physiologically in those tissues that undergo active remodeling in response to stress and hypoxia (Carmeliet, 2003; Folkman, 2007). However, it can be aberrantly activated during many pathological conditions such as cancer, diabetic retinopathy as well as numerous ischemic, inflammatory, infectious and immune disorders (Carmeliet, 2003; Ali and El-Remessy, 2009; Willis et al., 2011). Although the concept of proposing angiogenesis inhibitors as anticancer drugs received considerable skepticism when first presented by Dr. Folkman in the early 1970s (Folkman, 1971), active research in the field and subsequent clinical trials eventually resulted in US Food and Drug Administration (FDA) approval of bevacizumab for colorectal cancer in 2004 (Cohen et al., 2007). Since then, several angiogenic inhibitors have been identified. This review will provide an overview of the key mechanisms involved in tumor angiogenesis, classification of angiogenesis inhibitors as well as treatment rationales from the mechanistic point of view.

Sustained angiogenesis as a hallmark of cancer

Proliferating tumours tend to activate an angiogenic phenotype to fulfil their increased demand of oxygen and nutrients (Hanahan and Folkman, 1996; Carmeliet, 2005). Additionally, paracrine release of anti-apoptotic factors from activated endothelial cells in the newly formed vasculature supplies tumour cells with a survival privilege (Folkman, 2003). Consequently, in order to progress, tumors tend to activate an event called ‘angiogenic switch’ by shifting the balance of endogenous angiogenesis inducers and inhibitors towards a pro-angiogenic outcome. As a result, dormant lesion progresses into outgrowing vascularized tumor and eventually into a malignant phenotype (Hanahan and Folkman, 1996; Baeriswyl and Christofori, 2009). Hypoxia drives such imbalance through up-regulation of the transcription factor hypoxia inducible factor-1α (HIF-1α), which in turn increases the expression of many angiogenesis inducers as well as suppresses the expression of endogenous angiogenesis inhibitors (Pugh and Ratcliffe, 2003). In spite of that, accumulating evidence indicates that angiogenic cascade can be also driven by alternative HIF-1-independent pathways (Mizukami et al., 2007; Arany et al., 2008; Lee, 2013).

As summarized in Table 1, the angiogenesis inducers are a wide range of mediators that include many growth factors, a plethora of cytokines, bioactive lipids, matrix-degrading enzymes and a number of small molecules (Folkman, 1995; Folkman, 2003; Lopez-Lopez et al., 2004; Bouis et al., 2006; El-Remessy et al., 2007; Bid et al., 2011; MacLauchlan et al., 2011; Murakami, 2011; Fagiani and Christofori, 2013; Qin et al., 2013). Pro-angiogenic growth factors mostly activate a series of surface receptors in a series of paracrine and autocrine loops with the VEGF-A signaling representing the critical rate-limiting step, physiologically and pathologically. VEGF-A (traditionally known as VEGF) is the most potent VEGF isoform that acts mainly on VEGF receptor 2 (VEGFR2) to mediate vascular permeability, endothelial proliferation, migration and survival (Takahashi and Shibuya, 2005; Bouis et al., 2006). In spite of the well-established master roles of VEGF signaling in literature, those processes are probably accomplished through a highly regulated interplay between VEGF and other pro-angiogenic factors. In this context, basic fibroblast growth factor (bFGF) activation of the endothelium is required for maintenance of VEGFR2 expression and the ability to respond to VEGF stimulation (Murakami et al., 2011). Similarly, sphingosine-1-phosphate (S1P), a pleiotropic bioactive lipid that can directly contribute to tumor angiogenesis (reviewed in Sabbadini, 2011), is needed for VEGF-induced blood vessel formation, indicating the cooperation between S1P and VEGF in tumor angiogenesis (Visentin et al., 2006). As a net result, the pro-angiogenic interplay of those ligands and others dominates over the activities of two dozen endogenous angiogenesis inhibitors that can be either matrix-derived inhibitors or non–matrix-derived inhibitors (Nyberg et al., 2005).

Table 1. Pro-angiogenic mediators implicated in tumor angiogenesis

Category Examples References
Growth factors VEGFs Bouis et al., 2006
FGFs Ibid
TGFs Ibid
PDGFs Ibid
Insulin-like growth factors Lopez-Lopez et al., 2004; Bid et al., 2011
ANGs Fagiani and Christofori, 2013
Cytokines IL-8 Strieter et al., 2004
CSF-1 Lin et al., 2006
Bioactive lipids PGE2 Wang and Dubois, 2010
S1P Murakami, 2011
Matrix-degrading enzymes MMPs Bourboulia and Stetler-Stevenson, 2010
Heparanases Vlodavsky and Friedmann, 2001
Small mediators NO MacLauchlan et al., 2011
Peroxynitrite El-Remessy et al., 2007
Serotonin Qin et al., 2013
Histamine Qin et al., 2013

The multistep angiogenic process starts with vasodilation and increased permeability of existing vessels in response to tumor cell-secreted VEGF. This is accompanied by loosening of pericytes covering mediated by angiopoietin-2 (ANG2), a ligand of tyrosine kinase with immunoglobulin-like and EGF-like domains 2 (TIE2) receptor (Bergers and Benjamin, 2003; Jain, 2003; Fagiani and Christofori, 2013). Meanwhile, many secreted matrix-degrading enzymes, such as MMPs and heparanases, function in concert to dissolve the basement membrane and to remodel the extracellular matrix (ECM) as well as to liberate more pro-angiogenic growth factors (bFGF and VEGF) from matrix heparan sulfate proteoglycans (HSPGs) respectively (Houck et al., 1992; Whitelock et al., 1996; Vlodavsky and Friedmann, 2001; Tang et al., 2005; van Hinsbergh and Koolwijk, 2008). The overall chemotactic angiogenic stimuli guide endothelial cells to migrate, to align into tube-like structures and to eventually form new blood vessels. However, such blood vessels are characterized by being disorganized, chaotic, hemorrhagic and poorly functioning (Bergers and Benjamin, 2003).

The angiogenic phenotype in tumor micro-environment can further be sustained and extravagated by the recruitment of other types of stromal cells. Stromal cells such as fibroblasts, mesenchymal stem cells and various bone marrow-derived myeloid cells including macrophages, TIE2-expressing monocytes, neutrophils and mast cells contribute to tumor angiogenesis through their production of growth factors, cytokines and proteases (Murdoch et al., 2008; Joyce and Pollard, 2009; Cirri and Chiarugi, 2011). For example, in response to cancer cell-derived TGF-β, PDGF or bFGF, fibroblasts are transformed to an activated phenotype with a higher proliferative activity and myofibroblastic characteristics (Kalluri and Zeisberg, 2006; Cirri and Chiarugi, 2011). Such carcinoma-associated fibroblasts (CAFs) were shown to promote angiogenesis and metastasis by secreting large amounts of MMP-2 and MMP-9 as well as by expressing many cytokines and chemokines that resulted in immune cell infiltration (Gerber et al., 2009; Giannoni et al., 2010). Furthermore, it has been shown that PDGF-C produced by CAFs is able to elicit VEGF production from tumor cells, thereby sustaining the angiogenic shift (Crawford et al., 2009). Similarly, tumor-associated macrophages (TAMs), one of the bone marrow myeloid-derived cells, are induced to develop into polarized type II (alternatively activated or M2 macrophages), upon exposure to tumor hypoxia and tumor cell-derived cytokines (Leek et al., 2002; Rogers and Holen, 2011). M2 macrophages tend to produce many pro-angiogenic growth factors, cytokines and matrix-degrading enzymes such as VEGF, PDGF, bFGF, TNF-α, COX-2, MMP-9, MMP-7 and MMP-12 (Lewis and Pollard, 2006).

From another perspective, angiogenesis may be dispensable for progression of some malignancies. For example, some tumours may co-opt pre-existent vessels as an alternative way to obtain blood supply. Vessel co-option was first described in the brain, one of the most densely vascularized organs, in which tumours may develop in earlier stages without the activation of angiogenic response (Holashet al., 1999; Leenders et al., 2002; Bergers and Benjamin, 2003; Hillen and Griffioen, 2007). In another example, hypovascularized tumors such as pancreatic ductal adenocarcinoma may involve certain adaptation to flourish in the absence of prominent angiogenesis (Bergers and Hanahan, 2008). Obviously, in both cases, tumors may be intrinsically indifferent to angiogenesis inhibitors. However, in most other cases, therapy directed towards the vasculature of solid tumors is being considered as an important direction in cancer treatment.

Classification of angiogenesis inhibitors

Growth of newly formed vessels in tumor micro-environment can be inhibited directly by targeting endothelial cells in the growing vasculature or indirectly by targeting either tumor cells or the other tumor-associated stromal cells. Therefore, angiogenesis inhibitors can be classified into direct and indirect inhibitors (Kerbel and Folkman, 2002; Folkman, 2007).

Direct endogenous inhibitors of angiogenesis

Direct endogenous inhibitors of angiogenesis, such as angiostatin, endostatin, arrestin, canstatin, tumstatin and others, are fragments released on proteolysis of distinct ECM molecules. Endogenous inhibitors prevent vascular endothelial cells from proliferating, migrating in response to a spectrum of angiogenesis inducers, including VEGF, bFGF, IL-8 and PDGF (Kerbel and Folkman, 2002; Abdollahi et al., 2004; Mundel and Kalluri, 2007; Ribatti, 2009). This direct anti-angiogenic effect may be mediated by interference with endothelial integrins along with several intracellular signaling pathways (Mundel and Kalluri, 2007). For example, the ability of tumstatin-derived active peptide to inhibit angiogenesis and tumour growth is associated with the expression of the adhesion receptor, αvβ3 integrin, on tumor endothelial cells (Eikesdal et al., 2008). Through binding αvβ3 integrin, full tumstatin was found to inhibit endothelial cell activation of focal adhesion kinase, PI3K, Akt, mammalian target of rapamycin (mTOR) and others (Maeshima et al., 2002). Direct targeting of those signaling pathways by endogenous inhibitors was thought to be the least likely to induce acquired drug resistance because they target endothelial cells with assumed genetic stability rather than unstable mutating tumour cells (Kerbel and Folkman, 2002). However, endostatin has not yet led to any documented benefit to patients in randomized phase III trials, or even modest activity in phase II trials (Ellis and Hicklin, 2008).

Indirect inhibitors of angiogenesis

Indirect inhibitors of angiogenesis classically prevent the expression or block the activity of pro-angiogenic proteins (Folkman, 2007). For example, Iressa, an EGF receptor (EGFR) TK inhibitor (TKI), blocks tumour expression of many pro-angiogenic factors; bevacizumab, a monoclonal antibody, neutralizes VEGF after its secretion from tumour cells whereas sunitinib, a multiple receptor TKI, blocks the endothelial cell receptors (VEGFR1, VEGFR2 and VEGFR3), preventing their response to the secreted VEGF (Folkman, 2007; Roskoski, 2007). In addition, this class extends to include conventional chemotherapeutic agents, targeted therapy against oncogenes and drugs targeting other cells of the tumor micro-environment (Kerbel et al., 2000; Ferrara and Kerbel, 2005).

Conventional chemotherapeutic agents

Conventional chemotherapeutic agents have been shown to have anti-angiogenic properties in addition to the ability to induce direct cancer cell death. Such chemotherapeutic agents can affect the endothelial cell population in the tumour bed during treatment cycles because they have significantly higher proliferation rates than resting endothelium outside a tumor, making them more susceptible to cytotoxic effect (Kerbel et al., 2000; Folkman, 2003). However, the cyclic treatment rationale of cytotoxic drugs allows the potential damage to the tumour vasculature to be repaired during the long breaks. Thus, continuous low doses of chemotherapeutic agents were suggested as a way to reduce side effects and drug resistance (Drevs et al., 2004). This modality is termed metronomic therapy, and clinically, it refers to the daily administration of 5–10% of the phase II-recommended dose of the chemotherapeutic agent (Penel et al., 2012). The extended use of such low doses of cytotoxic agents elicits an anti-angiogenic activity through induction of endothelial cell apoptosis and decreasing the level of circulating endothelial precursors (Hamano et al., 2004; Shahrzad et al., 2008). In clinical investigations, metronomic dosing of cyclophosphamide and others showed promising efficacy in patients with advanced, multiple metastasized and/or multiple pretreated solid tumours (Lord et al., 2007; Fontana et al., 2010; Nelius et al., 2011; Gebbia et al., 2012; Briasoulis et al., 2013; Navid et al., 2013).

VEGF-targeted therapy

VEGF-targeted therapy includes neutralizing antibodies to VEGF (e.g. bevacizumab) or VEGFRs (e.g. ramucirumab), soluble VEGFR/VEGFR hybrids (e.g. VEGF-Trap) and TKIs with selectivity for VEGFRs (e.g. sunitinib and sorafenib; Baka et al., 2006; Ellis and Hicklin, 2008; Hsu and Wakelee, 2009). Bevacizumab, a humanized monoclonal antibody against all isoforms of VEGF-A, has been approved for the treatment of colorectal, lung, glioblastoma and renal cell carcinoma (Hsu and Wakelee, 2009). Many other clinical trials with promising efficacy were also conducted in other cancers such as head and neck cancer, hepatocellular carcinoma, ovarian cancer, metastatic melanoma and gastric cancer (Argiris et al., 2011; 2013; Burger et al., 2011; Ohtsu et al., 2011; Fang et al., 2012; Minor, 2012; Schuster et al., 2012; Van Cutsem et al., 2012). However, for metastatic breast cancer, bevacizumab had been initially granted an accelerated FDA approval, which was later withdrawn due to lack of improvement evidence in disease-related symptoms or overall survival (Burstein, 2011; Montero et al., 2012). Similarly, clinical trials showed that the addition of bevacizumab to the treatment regimens of advanced pancreatic cancer did not extend overall survival (Chiu and Yau, 2012). The neutralization of VEGF-A can also be achieved by soluble receptor construct (VEGF-Trap) that monomerically ‘traps’ the different isoforms of VEGF-A, in addition to VEGF-B and placental growth factor (Rudge et al., 2007). VEGF-Trap showed clinical benefit in a phase III trial of oxaliplatin pretreated metastatic patients with colorectal cancer, and is currently being investigated in a prostate cancer phase III trial (Gaya and Tse, 2012). TKIs are small molecules with different chemical structures that have the ability to interact physically with the highly conserved kinase domain shared by different VEGFRs as well as PDGF receptors (PDGFRs), FGF receptors (FGFRs), EGFR, Raf kinases and c-Kit (a receptor of the pluripotent cell growth factor, stem cell factor). Such interaction directly inhibits tyrosine phosphorylation and the subsequent many downstream pro-angiogenic signaling networks (Baka et al., 2006; Ivy et al., 2009). Those multi-targeted TKIs demonstrated efficacy against various solid malignancies in different clinical trials, some of which have lead eventually to FDA approval of sunitinib and sorafenib. Sunitinib, known to inhibit several receptor TKs (RTKs) including VEGFR1–3, PDGFR-α, PDGFR-β, c-Kit, colony-stimulating factor-1 receptor (CSF-1R) and Flt-3, was approved for the treatment of renal cell carcinoma and gastrointestinal stromal cell tumours. Sorafenib that acts also by inhibiting VEGFR1–3 and PDGFR-β in addition to the serine–threonine kinases Raf-1, B-Raf, was approved for hepatocellular carcinoma in addition to renal cell carcinoma (Llovet et al., 2008; Ivy et al., 2009; Huang et al., 2010).

FGF-targeted therapies

FGF-targeted therapies were recently reconsidered as promising anti-angiogenic and anti-tumor agents after a long period of little attention for drug development, partly due to redundancy (Bono et al., 2013). The FGFR superfamily with its 18 ligands and four receptors has been involved in endothelial cell migration, proliferation and differentiation (Presta et al., 2005). Therapeutic targeting of FGF/FGFR signalling was accomplished by either monoclonal antibodies that inhibit FGFs binding, small molecules that inhibit FGFR TK activity or allosteric modulators that bind the extracellular FGFR domain. Monoclonal antibodies against bFGF displayed potent anti-tumor and anti-angiogenic effects in different preclinical cancer models, which warrant further clinical evaluation (Zhao et al., 2010; Wang et al., 2012). Pan inhibitors of the FGFR TKs such as AZD4547 (blocks the activity of FGFR1–3) and ponatinib (blocks all the FGFR isoforms) elicited potent anti-tumor activities in preclinical investigations so they are currently being evaluated in clinical trials. Those inhibitors displayed the greatest potency in FGFR-driven cancer models, which may be attributed to the interference with the oncogenic functions of either amplified or constitutively active FGFR (Dutt et al., 2011; Zhao et al., 2011; Gavine et al., 2012; Gozgit et al., 2012). Accordingly, further studies are needed to evaluate the relative contribution of angiogenic versus oncogenic inhibitory mechanisms towards the overall anti-tumor activity. The allosteric antagonist of the FGFR, SSR128129E, showed a strong anti-angiogenic activity in addition to tumour growth and metastasis inhibitory effects in animal models of arthritis and cancer respectively. Because allosteric modulators leave a residual level of baseline signalling, they have the ability to fine-tune target biological responses. As a result, allosteric multi-FGFR inhibitors may have an improved benefit/risk ratio that is not attainable with the other TKIs (Bonoet al., 2013; Herbert et al., 2013). However, preclinical findings suggest that long-term clinical outcomes may improve with blockade of additional pro-angiogenic RTKs that may also reduce the risk of drug resistance (Hilberg et al., 2008). For example, dual inhibition of VEGFRs and FGFRs using brivanib produced enduring tumour stasis and angiogenic blockade following the failure of VEGF-targeted therapies (Allen et al., 2011). Furthermore, triple inhibition of FGFRs, VEGFRs and PDGFR(s) using dovitinib (TKI258) or nintedanib (BIBF 1120) displayed broad-spectrum anti-tumour activities in several tumour xenograft models as well as promising data in clinical trials. Combined inhibition of FGFR/VEGFR/PDGFR targets not only tumour cells, but also endothelial cells, pericytes and smooth muscle cells, resulting in an effective inhibition of tumour growth, angiogenesis and metastasis even in advanced tumour stages (Hilberg et al., 2008; Ledermann et al., 2011; Taeger et al., 2011; Chenet al., 2012; Angevin et al., 2013).

Oncogene-targeted therapy

Oncogenes, genes that cause the transformation of normal cells into cancerous cells, are thought to up-regulate many pro-angiogenic proteins. Therefore, anticancer drugs that were developed for their capacity to block an oncogene also have an indirect anti-angiogenic activity (Kerbel et al., 2000; Bergers and Benjamin, 2003; Folkman, 2003). For example, dasatinib and other inhibitors of sarcoma (Src), an aberrantly activated non-RTK associated with many human malignancies, showed potent anti-angiogenic effects through the down-regulation of VEGF and IL-8 (Summy et al., 2005; Han et al., 2006; Haura et al., 2010). Another example is to target the oncogenic Ras using farnesyl transferase (FT) inhibitors, which inhibit post-translational farnesylation of Ras that governs the latter’s activity (Awada et al., 2002). FT inhibitors were found to inhibit tumor VEGF expression and block FTase-dependent Ras activation, which is critically involved in VEGF-elicited angiogenic signal transduction and angiogenesis (Han et al., 2005; Izbicka et al., 2005; Kim et al., 2010). In addition to classical oncogenes inhibition, interference with other tumor-deregulated signaling pathways would offer another approach in targeting angiogenesis. For example, inhibitors of heat shock protein 90 (HSP90), a chaperone molecule known to protect oncoproteins from misfolding and degradation in the protein-rich intracellular environment, were found to prevent VEGF production and to disrupt multiple pro-angiogenic signalling pathways in numerous cancer cells. They were also shown to inhibit tumour growth and vascularity of different human tumor xenografts (Sanderson et al., 2006; Langet al., 2007; Eccles et al., 2008; Trepel et al., 2010; Moser et al., 2012). Proteasome inhibitors, such as bortezomib (PS-341) or MG-132, were also shown to reduce tumour growth and vascularity of squamous cell carcinoma and pancreatic cancer xenograft probably through inhibition of NF–κB-dependent release of pro-angiogenic gene products, VEGF and IL-8 (Sunwoo et al., 2001; Nawrocki et al., 2002; Matsuo et al., 2009). Similarly, inhibition of B-cell lymphoma 2 (Bcl-2), a prosurvival protein that regulates apoptosis by preventing the mitochondrial release of pro-apoptogenic factors, was shown to prevent NF-κB-mediated release of the pro-angiogenic factors IL-8 and CXC chemokine ligand 1 (CXCL1) as well as VEGF in tumor-associated endothelial cells and pancreatic cell lines respectively (Karl et al., 2005; Wang et al., 2008). Moreover, (−)-gossypol, a natural BH3 mimetic that inhibits BH3 domain of Bcl-2 as well as related prosurvival proteins (Bcl-xL and Mcl-1), was shown to remarkably decrease microvessel density in human prostate tumour PC-3 xenografts through decrease of VEGF and IL-8 release as well as blocking multiple steps in VEGF-activated biological events (Karaca et al., 2008; Pang et al., 2011).

Matrix degrading and remodelling-targeted therapy

Matrix degrading and remodelling are activated by tumors to modify local micro-environment, which in turn promote their angiogenic potential (Bergers et al., 2000; Vlodavsky and Friedmann, 2001). Up-regulation of expression and activity of several endogenous MMPs including MMP-2, MMP-9 as well as MMP-3 and MMP-7 have been identified in invasive tumors (for a review, see Bourboulia and Stetler-Stevenson, 2010). Consequently, inhibitors of MMPs were extensively pursued as a therapeutic strategy for treating cancer. Unfortunately, MMPs intervention strategies had met with limited clinical success because of severe toxicities and associated metastasis-promoting effect (Coussens et al., 2002; Devy et al., 2009). Furthermore, the paradoxical roles of tissue inhibitors of metalloproteinases (TIMPs) may contribute to such failure depending on the net balance of TIMPs and MMPs in tumour stroma (Jiang et al., 2002). As a result, efforts were directed at therapies exploiting endogenous MMP inhibitors, TIMPs or monoclonal antibodies against individual MMPs (Martens et al., 2007; Jarvelainen et al., 2009). For example, DX-2400, a highly selective fully human MMP-14 inhibitory antibody, was found to block pro-MMP-2 processing on tumor and endothelial cells, inhibited angiogenesis, and slowed tumor progression and formation of metastatic lesions (Devy et al., 2009). Alternatively, in order to reduce toxicity and enhance drug delivery, polymeric nanoparticulate delivery systems could be used to target individual components of ECM. For example, targeted delivery of antisense inhibitors of laminin-8, a vascular basement membrane component, by conjugation to the natural drug carrier β-poly(L-malic acid) significantly reduced tumour microvessel density and increased animal survival in an experimental model of glioblastoma (Fujita et al., 2006). Similarly, a nano delivery system that incorporate peptides against proteolytically processed type IV collagen significantly accumulated in tumors and blocked angiogenesis in experimental models (Mueller et al., 2009). However, the highly sulfated oligosaccharides, Heparan (HS) mimetics highly sulfated oligosaccharides, were shown to have a heparanase-inhibiting effect sequestering, in turn, many heparan sulfate proteoglycan (HSPG)-binding factors (Johnstone et al., 2010; Dredge et al., 2011). In preclinical studies, HS mimetics have effectively targeted multiple HSPG-dependent functions and have resulted in decreased in vivo tumor growth, tumor invasion, tumor metastasis and angiogenesis (Johnstone et al., 2010; Dredge et al., 2011; Zhou et al., 2011). Clinically, the heparanase inhibitor PI-88 showed preliminary efficacy as an adjunct therapy for post-operative hepatocellular carcinoma (Liu et al., 2009).

Tumour-associated stromal cell-targeted therapy

Tumour-associated stromal cells crosstalk is a perquisite for the formation of a tumour vasculature, an essential step for tumour progression (Lorusso and Ruegg, 2008). Interference with those crosstalk circuits through intervention of cellular adhesion (highlighted in next paragraph) or tumor-induced recruitment of different stromal cells may be considered as an indirect way of anti-angiogenic therapy (Ferrara and Kerbel, 2005). The latter can be supported by studies in which inhibition of macrophage infiltration, for example, by either genetic ablation of the macrophage CSF-1 or liposomal clodronate-induced macrophage depletion, was shown to delay the angiogenic switch and malignant transition (Giraudo et al., 2004; Lin et al., 2006). Furthermore, CSF-1R kinase inhibitors were found to reduce tumor-associated vascularity in two different tumor mouse models (Kubota et al., 2009; Mantheyet al., 2009). In addition, clodronate and other related bisphosphonates, originally used to treat skeletal complications in patients with tumour-induced osteolysis, were shown to exert potent anti-tumour and anti-angiogenic effects in many other studies (Fournier et al., 2002; Santini et al., 2003; Stathopoulos et al., 2008). Zoledronic acid, a third-generation bisphosphonate, was also found to reduce a number of tumour-associated macrophages and shift their phenotype from M2 to M1, resulting in a reduction in TAM-associated production of VEGF in murine models of spontaneous mammary carcinogenesis and mesothelioma (Coscia et al., 2010; Veltman et al., 2010). Clinically, repeated low-dose therapy with zoledronic acid, which maintains active drug plasma concentration, was able to induce an early remarkable and long-lasting decrease of VEGF levels in patients with cancer (Santini et al., 2007). In another example, inhibition of mobilization of neutrophils, from bone marrow and their infiltration into tumour, using neutralizing anti–prokineticin-2, an antibody against a secreted protein known also as BV8, was shown to impair the initial angiogenic switch in a multistage pancreatic beta cell tumorigenesis model (Shojaei et al., 2008). Furthermore, the neutralizing anti-BV8 was found to prevent myeloid cell-dependent tumour angiogenesis in several xenograft models (Shojaei et al., 2007). Cancer-associated fibroblasts (CAF) can also be targeted with thapsigargin analogue coupled with peptides specific for fibroblast activation protein (FAP), a CAF membrane-bound protease whose catalytic site has access to the peritumoural fluid of the tumor micro-environment. This extracellular activation results in the death of CAFs as well as pericytes and endothelial cells within milieu of different human tumor xenografts (Brennen et al., 2012).

Cell adhesion molecules (CAMs)-targeted therapy

CAMs are cell surface proteins known to be involved in binding with other counter-receptors on adjacent cells or surrounding ECM macromolecules (Aplin et al., 1998). Many CAMs, such as αv-integrins, E-selectin, N-cadherin and VE-cadherin, have been implicated in tumour angiogenesis (Bischoff, 1997; Tei et al., 2002; Nakashima et al., 2003; Weis and Cheresh, 2011). For example, αv-integrins are expressed on surface of endothelial cells and can determine whether cells can adhere to and survive in a particular micro-environment. A number of matrix-derived fragments have the ability to act as endogenous angiogenesis inhibitors through binding to integrins on endothelial cells, disrupting physical connections and suppressing signalling events associated with cell survival, migration and proliferation (Nyberg et al., 2005). Consequently, integrins antagonism using peptidomimetics (e.g. cilengitide), monoclonal antibodies (e.g. volociximab) or oral small-molecule compounds have been investigated in a wide range of malignancies (Huveneers et al., 2007). Cilengitide is a cyclized pentapeptide peptidomimetic designed to compete for the arginine-glycine-aspartic acid (RGD) peptide sequence, thereby blocking the ligation of the αvβ3 and αvβ5 integrins to matrix proteins (Hariharan et al., 2007). Cilengitide is mainly under clinical development for glioblastoma; however, clinical trials of other malignancies such as head and neck cancer as well as lung cancer were also initiated (Reardon and Cheresh, 2011; Vermorken et al., 2012; Manegold et al., 2013). Alternatively, cyclic peptides containing RGD motif could guide nanoparticulate delivery system, which incorporates anti-angiogenic cytotoxic agents such as doxorubicin, paclitaxel or combretastatin A4, to accumulate specifically in tumor vasculature with no overt systemic toxicity (Murphy et al., 2008; Ruoslahti et al., 2010; Wang et al., 2011). Volociximab, a chimeric humanized monoclonal antibody that selectively inhibits the αvβ1 integrin interaction with fibronectin, has been evaluated also in clinical trials for solid tumours such as renal cell carcinoma, recurrent ovarian cancer, advanced non–small-cell lung cancer and metastatic pancreatic cancer (Figlin et al., 2006; Evans et al., 2007; Jarvelainen et al., 2009; Vergote et al., 2009; Besse et al., 2013). Cadherins constitute a superfamily of molecules that mediate calcium-dependent cell–cell adhesions. The intracellular domains of cadherins directly bind to β-catenin and link with cytoskeletal components, providing the molecular basis for stable cell–cell adhesion (Zhang et al., 2010). Targeting cadherin signalling may also represent another way for tumor angiogenesis intervention. For example, ADH-1, a cyclic pentapeptide containing the cell adhesion recognition site (His-Ala-Val) required for N-cadherin adhesion, was shown to possess anti-angiogenic and anti-tumour activity (Blaschuk et al., 2005; Blaschuk, 2012). Similarly, monoclonal antibody directed against specific region of VE-cadherin was able to inhibit tumor angiogenesis and growth with no side effects on normal vasculature (Corada et al., 2002; May et al., 2005).

Inflammatory angiogenesis-targeted therapy

Targeting inflammatory angiogenesis, responsible for a substantial part of tumour vascularization initiated by infiltrating leukocytes, may be considered as another indirect anti-angiogenic strategy (Albini et al., 2005). Moreover, as mentioned before, tumour-infiltrating leukocytes contribute into malignant progression through production of many pro-inflammatory cytokines, chemokines and enzymes that can mostly induce angiogenic cascade (Balkwill et al., 2005). Such vital roles have been supported by the early observation that nonsteroidal anti-inflammatory drugs can inhibit tumour angiogenesis and, in turn, tumor progression (Albini et al., 2005). For example, ibuprofen was found to decrease tumor growth and metastatic potential in mice models through modulation of angiogenesis (Yao et al., 2005). Moreover, selective inhibitors of COX-2, an inducible enzyme that catalyses the production of prostanoids from arachidonic acid, were also shown to inhibit angiogenesis (Tsujii et al., 1998; Wei et al., 2004). The anti-angiogenic effect of COX-2 inhibitors may be contributed, in part, by decreasing the COX-2 metabolic product PGE2, the predominant PG in solid tumors known to stimulate cancer cells to produce pro-angiogenic factors such as VEGF and bFGF as well as many other factors belonging to CXC chemokines family (Strieter et al., 2004; Wang et al., 2006; Wang and Dubois, 2010). Members of the CXC chemokine family are heparin-binding proteins that possess disparate regulative roles in angiogenesis. For example, the ELR+ CXC chemokines, characterized by highly conserved three amino acid motifs (Glu-Leu-Arg; ‘ELR’ motif), are potent promoters of angiogenesis, whereas the IFN-inducible (ELR−) CXC chemokines are inhibitors of angiogenesis (Strieter et al., 2004). The use of repertaxin, originally designed to target the ELR+ CXC chemokine receptors CXCR1 and CXCR2 on neutrophils to prevent their migration to sites of inflammation, was found to inhibit tumor angiogenesis, thereby suppressing tumour progression in a genetic model of pancreatic ductal adenocarcinoma (Ijichi et al., 2011). It would be beneficial to explore other small-molecule CXCR2 antagonists that have already been developed for the treatment of inflammatory diseases in different preclinical models of cancer, especially inflammation-associated cancers (refer to Chapman et al., 2009 for a list of newly developed CXCR2 antagonists used in the treatment of inflammatory diseases of the lung).

Mechanisms of enhanced therapeutic efficacy

  • Dual targeting of tumor vasculature
  • Targeting different cell types of tumor micro-environment
  • Normalization of tumor vasculature
  • Chemosensitization of tumor cells
  • Interference with the repair of cytotoxic drug-induced damage and resistance mechanisms

Consequences of anti-angiogenic therapy with other anticancer therapy

  • Contrary to initial expectations, treatment with angiogenesis inhibitors was associated with unexpected toxicities. The toxicity profiles of those inhibitors reflect the systemic disturbance of growth factor signalling pathways that mediate their anti-angiogenic activity (Elice and Rodeghiero, 20102012). In this context, disturbance of the tight endothelial cell-platelet interaction that maintains vascular integrity results in bleeding complications, gastrointestinal perforations, and disturbed wound and ulcer healing (Verheul and Pinedo, 2007). In general, the incidence of those adverse effects increases when anti-angiogenic agent is combined with chemotherapy. For example, bleeding complications have been observed in patients with colorectal cancer treated with chemotherapy in combination with bevacizumab (Kabbinavar et al., 2003; Giantonio et al., 2006). In non–small-cell lung cancer, some patients treated with bevacizumab in combination with carboplatin and paclitaxel experienced severe or fatal pulmonary haemorrhage (Johnson et al., 2004). Furthermore, a higher incidence of gastrointestinal perforation was observed in patients with colorectal cancer given bevacizumab in combination with chemotherapy compared with chemotherapy alone (Hurwitz et al., 2004). Similarly, thrombotic events have been observed in patients treated with angiogenesis inhibitors, especially when these agents are given in combination with chemotherapy (Verheul and Pinedo, 2007). Treatment of patients with cancer with angiogenesis inhibitors is frequently associated with hypertension, which may require the addition of regular anti-hypertensive agent (Izzedine et al., 2009).

Summary and future directions

  • Angiogenesis is a critical process that occurs pathologically in many malignancies due to changing balance of endogenous angiogenesis inducers and inhibitors, leading to the activation of nearby endothelial cells to form new vasculature. Consequently, angiogenesis can be targeted to restrict initiation, growth and progression of most of angiogenesis-dependent malignancies. Numerous angiogenic inhibitors have been identified, some of which are currently being investigated in clinical trials and some others were even approved for cancer therapies. These angiogenesis inhibitors were classified based on their target into two main classes: direct and indirect inhibitors. Indirect angiogenesis inhibitors can be further subclassified based on their interference mechanisms with the angiogenic cascade. A list of major categories and molecular targets for angiogenesis inhibitors is shown in Table 2.
  • Most angiogenesis inhibitors conferred clinical benefits mainly when combined with other chemotherapeutic/targeted therapies rather than being used as monotherapy. Unfortunately, many anti-angiogenic agents were shown to be associated with overt systemic toxicity as well as resistance emergence and disease recurrence. Drug resistance in anti-angiogenic therapy may result from a plethora of pro-angiogenic factors released by inappropriately functioning host cells in the tumor micro-environment as a compensatory mechanism. Therefore, the strategy of targeting endothelial cells alone may not be enough as explained in the previous texts, requiring the proposal of different rationales in which other cellular compartments of tumor micro-environment are targeted to attain proper anti-angiogenic and anti-tumor response. That highlights the importance of considering tumor micro-environment as a dynamic system, as depicted in Figure 1 in which interference with any of its components may be an approach to interfere with cancer hallmarks, including angiogenesis.

9.5.5 LUCITANIB a VEGFR/FGFR dual kinase inhibitor in Phase 2 trials

Dr.  Anthony Melvin Crasto

source: http://medcheminternational.blogspot.com/2015/01/lucitanib-vegfrfgfr-dual-kinase.html

Lucitanib.png
LUCITANIB
6-[7-[(1-aminocyclopropyl)methoxy]-6-methoxyquinolin-4-yl]oxy-N-methylnaphthalene-1-carboxamide
6-(7-((l-aminocyclopropyl)methoxy)-6-methoxyquinolin-4-yloxy)- N-methyl- 1 -naphthamide
1058137-23-7 (E-3810 free base); 1058137-84-0  (E-3810 HCl salt)
E-3810, E-3810 amine, UNII-PP449XA4BH, E3810, Lucitanib [INN], AL3810
Molecular Formula:C26H25N3O4
Molecular Weight:443.4944 g/mol
PATENT SUBMITTED GRANTED
Spiro Substituted Compounds As Angiogenesis Inhibitors [US8163923] 2008-09-18 2012-04-24
A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
For in advanced solid tumors.
Lucitanib (E-3810): Lucitanib, also known as E-3810,  is a novel dual inhibitor targeting human vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptors (FGFRs) with antiangiogenic activity. VEGFR/FGFR dual kinase inhibitor E-3810 inhibits VEGFR-1, -2, -3 and FGFR-1, -2 kinases in the nM range, which may result in the inhibition of tumor angiogenesis and tumor cell proliferation, and the induction of tumor cell death. Both VEGFRs and FGFRs belong to the family of receptor tyrosine kinases that may be upregulated in various tumor cell type
Lucitanib (E-3810) Structure

Overview

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR α-ß). We own exclusive development and commercial rights to lucitanib on a global basis, excluding China. Lucitanib rights to markets outside of the U.S. and Japan have been sublicensed to Les Laboratoires Servier (Servier). We are collaborating with Servier on the global clinical development of lucitanib.

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Protein-binding, Protein-Protein interactions & Therapeutic Implications

Writer and Curator: Larry H. Bernstein, MD, FCAP 

7.3  Protein-binding, Protein-Protein interactions & Therapeutic Implications

7.3.1 Action at a Distance. Allostery_Delabarre_allostery review

7.3.2 Chemical proteomics approaches to examine novel histone modifications

7.3.3 Misfolded Proteins – from Little Villains to Little Helpers… Against Cancer

7.3.4 Endoplasmic reticulum protein 29 (ERp29) in epithelial cancer

7.3.5 Putting together structures of epidermal growth factor receptors

7.3.6 Complex Relationship between Ligand Binding and Dimerization in the Epidermal Growth Factor Receptor

7.3.7 IGFBP-2.PTEN- A critical interaction for tumors and for general physiology

7.3.8 Emerging-roles-for-the-Ph-sensing-G-protein-coupled-receptor

7.3.9 Protein amino-terminal modifications and proteomic approaches for N-terminal profiling

7.3.10 Protein homeostasis networks in physiology and disease

7.3.11 Proteome sequencing goes deep

7.3.1 Action at a Distance. Allostery_Delabarre_allostery review

DeLaBarre B1Hurov J1Cianchetta G1Murray S1Dang L2.
Chem Biol. 2014 Sep 18; 21(9):1143-61
http://dx.doi.org:/10.1016/j.chembiol.2014.08.007

Cancer cells must carefully regulate their metabolism to maintain growth and division under varying nutrient and oxygen levels. Compelling data support the investigation of numerous enzymes as therapeutic targets to exploit metabolic vulnerabilities common to several cancer types. We discuss the rationale for developing such drugs and review three targets with central roles in metabolic pathways crucial for cancer cell growth: pyruvate kinase muscle isozyme splice variant 2 (PKM2) in glycolysis, glutaminase in glutaminolysis, and mutations in isocitrate dehydrogenase 1 and 2 isozymes (IDH1/2) in the tricarboxylic acid cycle. These targets exemplify the drugging approach to cancer metabolism, with allosteric modulation being the common theme. The first glutaminase and mutant IDH1/2 inhibitors have entered clinical testing, and early data are promising. Cancer metabolism provides a wealth of novel targets, and targeting allosteric sites promises to yield selective drugs with the potential to transform clinical outcomes across many cancer types.

Based on knowledge acquired to date, there is no doubt that cancer metabolism provides a wealth of novel therapeutic targets and multiple innovative ways in which to exploit metabolic vulnerabilities for therapeutic benefit. More comprehensive reviews cover the breadth of metabolic targets that are currently under investigation (Stine and Dang, 2013; Vander Heiden, 2011). The following sections of this review focus on PKM2, glutaminase, and mutated IDH1/2 as exemplary metabolism targets under investigation for development of cancer therapies.
Drugging Glycolysis: Targeting Pyruvate Kinase Muscle Isozyme Alternative Splice Variant 2 PK catalyzes the last step of glycolysis, converting phosphoenolpyruvate (PEP) to pyruvate, while producing one molecule of ATP. The reaction encompasses two chemical steps: the first involves a phosphoryl transfer from PEP to ADP, forming an enolate intermediate and ATP, and the second involves protonation of the enolate intermediate, forming pyruvate (Robinson and Rose, 1972). PKM2 is one of four PK isoforms in humans. PKM1 and PKM2 result from the alternative splicing of exons 9 and 10 of the PKM gene, which encode a stretch of amino acids that differ at 23 positions between PKM1 and PKM2. PKM1 is constitutively active in skeletal muscle and brain tissue, but is not allosterically regulated. PKM2 is expressed in fetal and proliferating tissues, has low basal activity compared with PKM1, and is allosterically regulated. R-type pyruvate kinase (PKR) and L-type pyruvate kinase (PKL) are transcribed via different promoters from the PKLR gene. PKR is expressed in erythrocytes and PKL in the liver. PKR, PKL, and PKM1 exist as stable tetramers,whereas PKM2 forms tetramers (high activity form), dimers (low activity form), and monomers (Mazurek, 2011).

Figure 1. Central Metabolic Pathways Utilized by Cancer Cells *denotes mutated isoenzyme.

Pyruvate Kinase Muscle Isozyme Alternative Splice Variant 2 in Cancer Cell Metabolism Cancer cells predominantly express PKM2, which can be downregulated by tyrosine kinase growth factor signaling pathways, allowing metabolic flexibility. Phosphotyrosine peptides have been shown to suppress PKM2 activity by binding tightly to PKM2, thereby catalyzing the release of fructose 1,6-bisphosphate (FBP), resulting in a switch to the low activity dimer state (Christofk et al., 2008b; Hitosugi et al., 2009). This downregulation is thought to support tumor growth and proliferation by allowing for the shunting of glycolytic intermediates toward other biosynthetic pathways (i.e., pentose phosphate and serine pathways). In keeping with this model, the activation of PKM2 in cancer cells using small molecule agonists resulted in serine auxotrophy (Kung et al., 2012). Consistent with the hypothesis that PKM2 is a critical metabolic switch, there is growing evidence that, depending on the cellular stress environment, PKM2activity canberegulated byposttranslational modification such as acetylation (Lv et al., 2011), phosphorylation (Hitosugi et al., 2009), cysteine oxidation (Anastasiou et al., 2011), and proline hydroxylation (Luo et al., 2011). The utility of PKM2 activators in the clinic has yet to be determined, but recent work with tumor xenografts with a PKM2 activator suggests that this may be a viable approach (Parnell et al., 2013). As PKM2 tetramers show greater than 50-fold higher activity than PKM2 monomers (Anastasiou et al., 2012), one consideration when designing drugs to activate PKM2 for therapeutic means would be the need for small-molecule ligands capable of driving the enzyme toward its optimally active tetrameric form, thus forcing cancer cells into a less flexible metabolic state.

Structure of Pyruvate Kinase Muscle Isozyme Alternative Splice Variant 2 The structure of the PKM2 tetramer is summarized in Figure 2A. PKM2 is allosterically activated in a ‘‘feedforward’’ manner by the upstream glycolytic metabolite, FBP, which induces a shift to the active tetrameric conformation (Christofk et al., 2008b; Dombrauckas et al., 2005). PKM2 can be independently allosterically activated by serine (Chaneton et al., 2012), which binds in a distinct pocket that can also accommodate the inhibitor phenylalanine (Protein Data Bank [PDB] ID: 4FXJ). The binding of phenylalanine results in a tetrameric form distinct from the active conformer (Morgan et al., 2013). It is not clear how the change from serine to phenylalanine elicits such a dramatic change in protein behavior, or whether there is any biological interaction between serine activation and phenylalanine inhibition of PKM2 in cancer cells. Of note, PKM1 and PKL/R are not activated by serine, despite the conservation of the serine binding site in all PK isoforms.
Figure 2. Three Different Metabolic Enzymes and Their Allosteric Inhibitors Protomers are depicted as cartoon ribbons in blue, green, yellow, and cyan. Synthetic allostery is depicted in stick format with red highlight. (A) Structure of tetrameric PKM2:AGI-980 (4:2 complex) from PDB 4G1N. AGI-980 is shown in stick rendering near the center of tetramer. Each PK monomer consists of four domains, usually designated A, B, C, and N (Dombrauckas et al., 2005). The tetramer is a dimer-of-dimers with approximate D2 symmetry. The dimer is formed between the A domains of each monomer, while the tetramer is formed via dimerization along the C subunit interfaces of each dimer. The active site of PKM2 lies within a cleft between the A and B domain, illustrated by a PEP analog (red spheres). The FBP binding pocket is located entirely within the C domain (pink spheres). The natural allosteric site of serine is also shown (black spheres). (B)Tetrameric GAC:BPTES (4:2 complex) from PDB 3UO9. Glutamate molecules are shown as spheres. (C) Dimeric IDH2R140Q:AGI-6780 (2:1 complex) from PDB 4JA8 (Wang et al., 2013). NADP molecules are shown as spheres.
Discovery of Allosteric Activators of Pyruvate Kinase Muscle Isozyme Alternative Splice Variant 2 A number of small molecules that potently activate PKM2 have been discovered by various groups (Table 1). Interestingly, all seven X-rayco-complexescurrentlyavailableshowcompoundsbound at a novel binding pocket distinct from the FBP and serine binding sites, which would otherwise allow cells to overcome negative regulation by phosphotyrosines (Kung et al., 2012). The compounds found in structures 3GQY, 3GR4 (Boxer et al., 2010), 3H6O (Jiang et al., 2010), 3ME3, and 3U2Z (Anastasiou et al., 2012) were identified by screening the NIH Small Molecule Repository, and can be classified into two distinct chemical series, both of which establish very similar interactions with PKM2 (Table 1). Analogues in these two classes selectively activated PKM2 allosterically with good selectivity against PKM1, PKL, and PKR (Anastasiou et al., 2012; Boxer et al., 2010; Jiang et al., 2010). The molecule found in the structure 4JPG (Guo et al., 2013) is similar to the two series described above, where the pyrimidone ring is found between the two Phe26 residues (Table 1). Interestingly, the activator found in the 4G1N structure (Kung et al., 2012) sits in the same pocket as the NIH compounds. However, the interactions are quite different, with the side chains of the two Phe26 that line the pocket assuming distinct conformations. This activator wraps around the two aromatic residues, which pushes it closer to the walls of the pocket, allowing for a richer series of interactions with PKM2 (Table 1). There are two additional series of PKM2 activators that have been reported for which no structural information is available (Table 1)(Parnell et al., 2013; Xu et al., 2014; Yacovan et al., 2012). Members of this series were shown to have an activation level comparable to that of FBP, with selectivity for PKM2 over PKL, PKR, and PKM1. PKM2 offers a very interesting example of an allosterically regulated enzyme. Different allosteric sites have so far been identified for three different types of activator (FBP, serine, and small-molecule ligands) and all activate PKM2 by stabilizing the tetrameric form. It is remarkable that molecules as small as serine can dramatically alter this protein’s conformational landscape and aggregation state and lead to an active enzyme. This unusual allosteric site revealed by the small-molecule ligands is of particular curiosity, largely because neither its function nor its native ligands are known. All of the drug-like activators described above bind at the dimer–dimer interface and seem to act by displacing water from the mainly apolar pocket, thus contributing to the stabilization of the tetramer. While these PKM2 activators show promising preclinical data, none have yet entered clinical development.

Table 1. Biochemical Properties of Small Molecule PKM2 Inhibitors Series PDB ID Ligand Reference Binding Characteristics

Substituted N,N’diarylsulfonamide 3GQY (Boxer et al., 2010)

  •  All completely buried within A-A’ interface, 35A ˚ from FBP pocket
  •  Binding pocket lined with residues equivalent to those of PKM2 molecules forming A-A’ interface
  •  All sandwiched between phenyl rings of the two Phe26 from different monomers
  •  All additionally interact with side chain of Phe26 through slightly distorted T-shaped p-p interactions (two such interactions for substituted N,N0diarylsulfonamides and one for thieno[3,2-b]pyrrole[3,2-] pyridazinones)
  1. 3GR4 (Boxer et al., 2010) 3ME3 (Anastasiou et al., 2012)
  2. Thieno[3,2-b]pyrrole [3,2-d]pyridazinone 3H6O (Jiang et al., 2010)
  3. 3U2Z (Anastasiou et al., 2012)
  4. 2-((1H-benzo[d]imidazol1-yl)methyl)-4H-pyrido [1,2-a]pyrimidin-4-ones
  5. 4JPG (Guo et al., 2013)
  • Pyrimidone ring found between the two Phe26 residues forming p-p interactions with the aromatic rings
  • Carbonyl interacts with a bridging water molecule
  • Benzimidazole reaches a region of the activator pocket that is not occupied in any of the published crystal structures
  • One of the imidazole nitrogens forms an H-bond with Lys311, which is normally part of a salt bridge to Asp354

Quinolone sulfonamides 4G1N (Kung et al., 2012)

  •  Quinoline moiety sits on a flat, mainly apolar surface defined by Phe26, Leu27 and Met30 from chain A and Phe26, Tyr390 and Leu394 from chain A’
  •  One of the two oxygen atoms of the sulfonamide accepts an H bond from the backbone oxygen of Tyr390, the other interacts with a water molecule
  •  The oxygen of the amide moiety forms an H-bond with side-chain nitrogen of Lys311
  •  Terminal aromatic ring sits in the other copy of the quinoline pocket d Aromatic rings of the side chains of the two Phe26 lining the pocket almost perpendicular (not parallel); activator wrapped around the two aromatic residues

3-(trifluoromethyl)-1Hpyrazole-5-carboxamide (Parnell et al., 2013; Xu et al., 2014)

  • Cocrystal structure of one compound bound to tetrameric PKM2 obtained but file not available for download from PDB: described as bound to the allosteric site at the dimer–dimer interface

5-((2,3-dihydrobenzo[b] [1,4]dioxin-6-yl)sulfonyl)-2methyl-1-(methylsulfonyl) indoline scaffold (Yacovan et al., 2012)

  • Cocrystal structure of one compound bound to PKM2 obtained but not available for download from the PDB: described as bound to dimer interface
  • Interactions very similar to those established by thieno [3,2-b]pyrrole[3,2-d]pyridazinone series above

Drugging Glutaminolysis: Targeting the Glutaminase C Variant Glutaminase catalyzes the conversion of glutamine to glutamate and ammonia. Glutamate can be oxidized to a-ketoglutarate (aKG), which then anaplerotically feeds into the TCA cycle as a means of providing proliferating cells with biosynthetic intermediates and ATP (Figure 1); glutamate is also used as a substrate for the generation of glutathione, which provides protection from redox stress (Hensley et al., 2013; Shanware et al., 2011). The ammonia produced during the reaction can be used in certain tissues like the kidney to provide pH homeostasis, and nitrogen derived from glutamine is utilized in nucleotide biosynthetic and glycosylation pathways.

Table 2. Characteristics of Small Molecule Glutaminase Inhibitors

BPTES N-(5–[1,3,4]thiadiazol-2yl)-2-phenylacetamide 6 (Shukla et al., 2012)

  • Similar potency but better water solubility vs. BPTES d Attenuated growth of P493 human lymphoma B cells in vitro d Diminished tumor growth in P493 tumor xenograft SCID mice with no apparent toxicity

CB-839 (Calithera) (Gross et al., 2014)

  • Orally bioavailable d Binds at allosteric sites of GLS1 KGA and GAC d Potent, selective, time-dependent reversible inhibition with slow recovery time
  • Anti-proliferative activity (double-digit nM potency) in cellular proliferation assays in wide range of tumors
  • Currently in Phase I trials of locally-advanced/metastatic refractory solid tumors (triple negative breast cancer, NSCLC, RCC, mesothelioma) and hematological cancers [Clinicaltrials.gov: NCT02071927, NCT02071862, NCT02071888]

Dibenzophenanthridines Compound 968 (Katt et al., 2012; Wang et al., 2010)

  • Modest potency in the low mM concentrations d Loses all inhibitory activity against glutaminase activated by preincubation with inorganic phosphate (phosphate does not affect BPTES potency)
  • Anti-proliferative activity in breast cancer cell line at 10 mmol/L concentration

There are three isoforms of IDH. IDH1 is located in both the peroxisome and the cytosol, whereas IDH2 and IDH3 are located in mitochondria. It is unclear what the relative contributions of the IDH2 and IDH3 isoforms are to overall mitochondrial TCA function. IDH1 and IDH2 are both obligatory homodimeric proteins and use NADP+ as a cofactor, whereas IDH3 uses NAD+ as a cofactor and is a heterotrimeric protein comprising alpha, beta, and gamma subunits. All three isozymes require either Mg2+ or Mn2+ asdivalent metal cofactors for catalysis.The dimeric structure of IDH2 is shown in Figure 2C.

Mutant Isocitrate Dehydrogenase in Cancer Cell Metabolism The role of IDH mutations in cancer metabolism was recognized following the observation of frequent and recurrent mutations of IDH1 and IDH2 in patients with glioma and AML, initially identified by genomic deep sequencing and subsequent comparative genetic analyses (Parsons et al., 2008; Yan et al., 2009). These mutations were originally characterized as loss of function (Mardis etal.,2009; Parsonsetal.,2008; Yanet al.,2009), suggesting that mutated IDH acts as a tumor suppressor due to the loss of catalytic conversion of isocitrate to aKG (Zhaoetal., 2009). However, with the exception of cases of haploinsufficiency, the heterozygous mutation pattern of IDH is more consistent with an oncogene role. Subsequently, IDH mutations were shown to possess the neomorphic activity to generate the oncometabolite, 2-hydroxyglutarate (2HG) (Dang et al., 2009; Gross et al., 2010; Ward et al., 2010). With a single codon substitution, the kinetic properties of the mutant IDH isozyme are significantly altered, resulting in an obligatory sequential ordered reaction in the reverse direction (Rendina et al., 2013). Indeed, the critical kinetic observation of mutant IDH was not only the loss of affinity for isocitrate, but also a dramatic increase in NADPH affinity by three orders of magnitude (Dang et al.,2009), suggesting a substantial change in protein dynamics imparted by the mutation. The only known homeostatic 2HG clearance mechanism is the relatively inefficient reconversion of 2HG back to aKG by D-2hydroxyglutarate dehydrogenase. Therefore, 2HG accumulates when over-produced by mutant IDH. 2HG itself has been shown to be sufficient to drive the malignant phenotype (Rakheja et al., 2013). Abnormally high 2HG levels impair aKG-dependent dioxygenases through competitive inhibition, including those that modify DNA and histones (i.e., Jumonji domain-containing histone demethylases and the ten-eleven translocation (TET) family of 50-methylcytosine hydroxylases) (Chowdhury et al., 2011; Figueroa et al., 2010), as well as EglN prolyl hydroxylase in regulating hypoxia-inducible factor (Losman et al., 2013). This results in altered epigenetic status that blocks cell differentiation. These findings, combined with the inhibitory effects of fumarate and succinate on the same families of aKG-dependent enzymes, highlight a critical and fascinatingnetwork that ties together central metabolic pathways and epigenetic control. Remarkably, mutations in TET2 are mutually exclusive with IDH mutations in AML, strongly suggesting that, in this context, the tumorigenic effects of 2HG are at least in part driven by inhibition of TET2. The precise targets of IDH mutations with associated 2HG production (and TET2 mutations) that promote tumorigenesis are currentlyunknown;however,itisclearthatIDH1/2andTET2mutations lead to a block in hematopoietic cell differentiation (Figueroa et al., 2010; Lu et al., 2012; Moran-Crusio et al., 2011; Wang et al., 2013). To date, no IDH3 mutation associated with cancer has been reported (Krell et al., 2011; Reitman and Yan, 2010), suggesting that the role of IDH1/2 has a greater impact on tumorigenesis. Targeting mutated isoforms of IDH1/2 therefore presents a logical approach to cancer therapy. A consideration in designing suchdrugsistheheterozygoussomaticnatureoftheIDH1/2mutation, which likely yields a mixture of homo- and heterodimers; statistically, heterodimers should be the major species in vivo. Mutant homodimers and wild-type-mutant heterodimers both efficiently catalyze the production of 2HG from aKG (Dang et al., 2009; Rendina et al., 2013). However, the heterodimer is potentially more oncogenic, as it is more efficient at producing 2HG than homodimeric mutants (Pietrak et al., 2011) due to an increased local concentration of substrate while conserving NADPH. The heterodimer as a molecular target therefore becomes an important consideration in this scenario.

Structure of Isocitrate Dehydrogenase Structurally, both IDH1 and IDH2 comprise three main domains: the large domain, the small domain, and the clasp region (Yang et al., 2010). A simplified description of protein motion is provided in Figure 3 (Rendina et al., 2013; Xu et al., 2004). The dynamic of motion may differ slightly between IDH1 and IDH2 mutants. IDH1 mutants appear to open wider than IDH2 mutants to the point of unwinding a helix termed ‘‘seg2’’ (Yang et al., 2010). In contrast, the open form of IDH2 does not involve the melting of any secondary structure, and as a consequence has a much narrower range of motion (Taylor et al., 2008; Wang et al., 2013). This differential in protein dynamics could possibly explain the differential responses of IDH1 and IDH2 to inhibitors. X-ray structures of IDH3 have not yet been reported, but it appears to be distinct from IDH1 and IDH2 in terms of primary sequence and predicted quaternary organization (Kim et al., 1995; Ramachandran and Colman, 1980). There are three arginine residues in the enzyme active site that are predicted to play a central role in electrostatic stabilization and proper geometric orientation of isocitrate via its acidic moieties as the substrate binds in the active site. With the exception of the novel G97D or G97N codon mutation (Ward et al., 2012), virtually all confirmed IDH mutations that generate high levels of 2HG occur in one of these arginines (i.e., IDH1-R132 and IDH2-R172/R140) (Losman and Kaelin, 2013) and have in common a substitution of one of the diffuse positive charges of the respective arginine’s guanidinium moiety.
Discovery of Inhibitors against Mutated Isocitrate Dehydrogenase Several inhibitors of mutant IDH isoforms that block 2HG production in vitro and in vivo have been recently described. The first potent and specific IDH1 inhibitors reported were the phenylglycine series, specifically AGI-5198 (Popovici-Muller et al., 2012; Rohle et al., 2013) and subsequently ML309 (Davis et al., 2014)(Table 3), which were shown to be rapid-equilibrium inhibitors specific for IDH1-R132-codon mutations. These compounds inhibited IDH1-R132H competitively with respect to aKG and uncompetitively with respect to NADPH, suggesting that they preferably bind to the enzyme-NADPH ternary complex. Notably, they do not appreciably cross-react against the IDH2-R140Q mutant isozyme, suggesting a unique binding mode in IDH1-R132 that does not favorably exist in IDH2R140. Because no X-ray co-complex has been reported for this series, the exact mode of binding cannot be ascertained at this time. Preclinical data indicated 2HG inhibition and antitumor effects in vitro and in vivo (Table 3). These phenylglycine compounds appear to be excellent chemical tools for tumor biology investigation, but optimization of their properties is likely required for further therapeutic development. Co-complexes of IDH1-R132H with two different 1-hydroxypyridin-2-one inhibitors have been reported (Zheng et al., 2013), but the quality of the crystal structure data supporting the mechanism of inhibition is poor. AG-120, a selective, potent inhibitor of mutated IDH1, is currently in clinical development for the treatment of cancers with IDH1 mutations (Table 3), but there is currently no published information on this inhibitor. Another inhibitor of mutated IDH1 has been reported recently (Table 3) (Deng et al., 2014). Co-complex X-ray studies revealed that Compound1 binds mutated IDH1 allosterically at the dimer interface resulting in an asymmetric open conformation. Distinctively, Compound 1 displaces the conserved catalytic Tyr139 and further disrupts the Mg2+ binding network, consistent with kinetic results of competitive inhibition with respect to Mg2+, but not with aKG substrate. Others have reported modeling of inhibitors into the active site of IDH1, but experimental evidence is lacking (Chaturvedi et al., 2013; Davis et al., 2014). The first reported potent and selective IDH2 inhibitor was the urea-sulfonamide series, AGI-6780 (Wang et al., 2013), a timedependent slow-tight binder to IDH2-R140Q exhibiting noncompetitive inhibition with respect to substrate and uncompetitive inhibition with respect to NADPH, and nanomolar potency for 2HG inhibition (Table 3). This compound showed good inhibitory selectivity for IDH2-R140Q, with no effect on the closely related IDH1 and IDH1-R132H isozymes. At doses that effectively blocked 2HG to basal levels, AGI-6780 induced differentiation of TF-1 erythroleukemia and primary human AML cells in vitro, suggesting potential to reverse leukemic phenotype in AML tumors harboring the IDH2 mutation. Unlike the case of IDH1 above, the published structure of AGI-6780 co-complexed with IDH2-R140Q allows for detailed analysis of its inhibitory mechanism (Wang et al., 2013). In the X-ray structure, a single molecule
of AGI-6780 binds at the interface of two protomers (Figure 2C). The allosteric inhibition appears to arise from the ability of AGI6780 to keep the IDH2-R140Q mutant enzyme in an open orientation, thereby preventing the NADPH cofactor and substrate aKG from coming close to the catalytic Mg2+ binding site (see Figure 3). The highly symmetric AGI-6780 binding pocket extends deep into the protein interface and is closed over by loops composed of residues 152–167, which also fold over the binding pocket, providing anexplanation for the time-dependent inhibition kinetics. AGI-6780 makes several direct H-bond interactions from its urea group and amide nitrogen to Gln316, but a significant amount of binding energy arises from van der Waals contacts between the protein and hydrophobic surfaces of AGI-6780. The in vivo potential for this compound is not known, since its pharmacokinetic properties were not reported. Nevertheless, this effective mode of inhibition serves as an important molecular model for the design of bioisosteric compounds. OtherIDH2inhibitorsareunderdevelopment,notablyAG-221, a first-in-class, orally available inhibitor (Table 3) which demonstrated a survival advantage in a preclinical study of a primary human IDH2 mutant AML xenograft mouse model (Yen et al., 2013). Early phase I clinical trial data for AG-221 show promise, with meaningful clinical responses in evaluable AML patients harboring IDH2 mutations (Stein et al., 2014). To date, there is no published example of a molecule that inhibits both IDH1 and IDH2 mutant isoforms with equipotency.

Table 3.Characteristics of Small Molecule Inhibitors of Mutant IDH

PhenylglycineAGI-5198 (Popovici-Mulleretal., 2012; Rohleetal.,2013)
N-cyclohexyl-2-(N-(3-fluorophenyl)-2(2-methyl-1H-imidazol-1-yl)acetamido)2-(o-tolyl)acetamide IDH1-R132H

  • Good potency against enzyme and in U87cell line overexpressing R132H mutation (IC50= 70nM)
  • Good oral exposure in rodents at high doses (>300mg/kg), which were likely at levels saturating hepatic clearance mechanisms
  • Plasma 2HG inhibition > 90% (BID dosing) in xenograft model of U87-R132H tumors
  • Promoted differentiation of glioma cells via induced demethylation of histone H3K9me3 and expression of genes associated with gliogenic differentiation at near-complete 2HG inhibition
  • inhibited plasma 2HG and delayed growth of IDH1-mutant but not wild-type glioma xenografts in mice

ML309 (Davis et al.,2014)
2-(2-(1H-benzo[d]imidazol-1-yl)-N-(3fluorophenyl)acetamido)-N-cyclopentyl2-o-tolylacetamide IDH1-R132H IDH1-R132C dIC50=68nM(R132H)

  • Inhibited 2HG production in glioblastoma cell line (IC50 = 250 nM) with minimal cytotoxicity
  • 1-hydroxypyridin2-one Compounds2and3 (Zhengetal.,2013)
    6-substituted1-hydroxypyridin-2-oneIDH1-R132H IDH1-R132C
  • K i= 190 and 280 nM (forR132H)
  • Inhibited production of 2HG in IDH1 mutated cells

Undisclosed
AG-120 (Agios)
Undisclosed
IDH1

  • Orally available, selective, potent inhibitor
  • PhaseI studies ongoing in advanced solid tumors (NCT02073994; NCT02074839)

Allostery as an Approach to Drugging Metabolic Enzymes Is Important in Cancer All enzymes discussed in this article are allosterically targeted by small molecule modulators. With the exception of the enzymes of lipid metabolism, it is striking that there are very few examples of the regulation of metabolic enzymes by drug-like molecules at the catalytic site. We believe that this observation will hold true for the wider set of metabolic enzymes. Metabolic pathways are typically regulated by upstream and downstream metabolites through feedforward and feedback mechanisms. This regulation occurs typically through binding at allosteric sites, which have distinctly different properties relative to active sites. Therefore regulation can come from effectors that may have very different properties to the substrate. This review describes the potential therapeutic impact of specific allosteric regulators of PKM2, glutaminase, and IDH. Additionally, preclinical studies of tool compounds demonstrated that allosteric regulators of other enzymes involved in cancer cell metabolism could provide more therapeutic opportunities (Table 4). Substrates and products of metabolic enzymes tend to be small and very polar, and often include crucial metal ions and their ligands, so it is likely that targeting their catalytic pockets will yield molecules with similar properties. From a drug-discovery point of view, targeting allosteric sites is appealing as hydrophilic substrate-binding sites are generally not hospitable to strong interactions with small molecule drugs, which gain potency to a large extent through hydrophobic interactions. In addition, as activity of most metabolic enzymes is regulated by multimerization, the formation of multimers provides opportunity for binding sites to form at protein–protein interfaces.

Table 4. Examples of Allostery in Cancer Cell Metabolism

TH           Tyrosine hydroxylase         Haloperidol                                           Activator             Catecholamine metabolism               (Casu and Gale, 1981)
PDK1      Pyruvate dehydrogenase
kinase isozyme1                  3,5-diphenylpent-2-enoicacids                         Activator             TCAcycle                                                (Stroba et al., 2009)
BCKDK  Branched chain keto acid
dehydrogenase kinase   (S)-a-chloro-phenylpropionicacid[(S)-CPP]     Inhibitor              Branch-chain amino acid                   (Tso et al., 2013)
ACACA   Acetyl-CoA carboxylase
alpha                                 5-tetradecyloxy-2-furoicacid (TOFA)                  Inhibitor              Fatty acid  synthesis                            (Wang et al.,2009)

FBP1     Fructose-1,6
bisphosphatase1               Benzoxazole benzene sulfonamide1                    Inhibitor              Glycolysis                                        (von Geldern et al., 2006)
ALADA minolevulinate
dehydratase                     wALAD in1 benzimidazoles                                     Inhibitor              Haem synthesis                                    (Lentz et al., 2014)
TYR       Tyrosinase         2,3-dithiopropanol                                                   Inhibitor              Melanin metabolism                    (Wood and Schallreuter, 1991)
DBHD  opamine beta
hydroxylase-2H-phthalazinehydrazone (hydralazine;HYD)
2-1H-pyridinonehydrazone (2-hydrazinopyridine;HP)
2-quinoline-carboxylicacid (QCA)
1H-imidazole-4-aceticacid (imidazole-4-aceticacid;IAA)                             Inhibitor         Neurotransmitter synthesis                    (Townes et al.,1990)
DCTD   dCMP
deaminase        5-iodo-2’-deoxyuridine5’-triphosphate                                 Inhibitor          Nucleotide metabolism                      (Prusoff and Chang, 1968)
TYMP  Thymidine
phosphorylase     5’-O-tritylinosine (KIN59)                                                    Inhibitor          Nucleotide metabolism                         (Casanova et al.,2006)
TYMS Thymidylate
synthase         1,3-propanediphosphonicacid (PDPA)                                     Inhibitor          Nucleotide   metabolism                        (Lovelace et al.,2007)

Figure 3. Simplified Description of IDH Protein Motion The large domain (residues 1–103 and 286–414) forms nearly all of the NADPH cofactor binding residues and roughly half of the substrate binding residues.The small domain(residues 104–136 and 186–285) contains the remaining substrate binding residues and the metal binding residues. The interface between the two protomers is formed by both the small domain and the clasp region (residues 137–185). The large domain moves away from the small domain to facilitate NADPH cofactor exchange and substrate binding. The large domain then closes up against the small domain, thereby completing the substrate binding pocket and bringing the cofactor, substrate, and metal into close contact with each other and with the key catalytic residues to facilitate hydride transfer between substrate and cofactor and enzyme-assisted carboxylation/decarboxylation. Subsequent opening of the large domain from the small domain would enable product release and cofactor exchange to complete the catalytic cycle (Rendina et al., 2013; Xu et al., 2004).

7.3.2 Chemical proteomics approaches to examine novel histone modifications

Xin LiXiang David Li
Current Opinion in Chemical Biology Feb 2015; 24:80–90
http://dx.doi.org/10.1016/j.cbpa.2014.10.015

Highlights

  • A variety of novel histone PTMs have been identified by MS-based methods.
  • Regulatory mechanisms and cellular functions of most novel histone PTMs remain unknown, due to lack of knowledge about their readers, erasers and writers.
  • Chemical proteomics approaches provide valuable tools to characterize novel histone PTMs.
  • The application of photoaffinity probes helps the profiling of histone PTMs’ readers, erasers and writers.

Histone posttranslational modifications (PTMs) play key roles in the regulation of many fundamental cellular processes, such as gene transcription, DNA damage repair and chromosome segregation. Significant progress has been made on the detection of a large variety of PTMs on histones. However, the identification of these PTMs’ regulating enzymes (i.e. ‘writers’ and ‘erasers’) and functional binding partners (i.e. ‘readers’) have been a relatively slow-paced process. As a result, cellular functions and regulatory mechanisms of many histone PTMs, particularly the newly identified ones, remain poorly understood. This review focuses on the recent progress in developing chemical proteomics approaches to profile readers, erasers and writers of histone PTMs. One of such efforts involves the development of the Cross-Linking-Assisted and SILAC-based Protein Identification (CLASPI) approach to examine PTM-mediated protein–protein interactions.

Table 1    Novel histone PTMs                      functions
1             Lysine formylation             Arising from oxidative damage of DNA modification sites overlap with lysine acetylation and methylation, potentially interfere with normal regulation of these PTMs

2      Lysine propionylation  p300,c CREB-binding protein,c Sirt1,c Sirt2,c Sirt3c
Structurally similar with lysine acetylation, regulated by same set of enzymes, H3K23pr may be regulatory for cell metabolism
3    Lysine butyrylation       p300,c CREB-binding protein,c Sirt1,c Sirt2,c Sirt3c
Structurally similar with lysine acetylation, regulated by same set of enzymes
4    Lysine malonylation    Sirt5c
Changing the positively charged lysine to negatively charged residue, likely to affect the chromatin structure
5   Lysine succinylation    Sirt5c
A  mutation to mimic crotonyl lysine that changes lysine to glutamic acid of histone H4K31, reduces cell viability
6  Lysine crotonylation   Sirt1,c Sirt2,c Sirt3
Enriched at active gene promoters potential enhancers in mammalian genomes, male germ cell differentiation
7 Lysine 2-hydroxyiso
butyrylation                     HDAC1-3c
Associated with gene transcription
8  Lysine 4-oxononoylation    Modified by 4-oxo-2-nonenal, generated under oxidative stress, prevents nucleosome assembly in vitro
9 Lysine 5-hydroxylation   JMJD6
suppress lysine acetylation and methylation
10 Glutamine methylation   Nop1  (yeast), fibrillarin (huma)
human histone H2AQ105
11 Serine and
threonine GlcNAcylation  O-GlcNAc transferase
H2BS112 GlcNAcylation promotes K120 monoubiquitination, H3S10 GlcNAcylation suppresses phosphorylation of site
12 Serine and threonine acetylation
13 Serine palmitoylation   Lpcat1
catalyzed H4S47 palmitoylation, Ca2+-dependent, regulates global RNA synthesis
14  Cysteine glutathionylation
H3.2 and H3.3
conserved cysteine, but not H3.1, destabilize the nucleosomal structure
15 Cysteine fatty-acylation
H3.2 C110
16 Tyrosine hydroxylation

Fig. 1. Schematic description of a MS-based method for the identification of novel histone PTMs.

http://ars.els-cdn.com/content/image/1-s2.0-S1367593114001562-gr1.sml

Fig. 2. Chemical proteomics approaches to profile readers and erasers of histone PTMs.
(a) Photo-cross-linking strategy to capture proteins recognizing histone PTMs.
(b) Chemical structure of photoaffinity peptide probes.
Modifications of interest were labeled in green; photo-cross-linkers were labeled in red; chemical handles (alkyne) were labeled in blue; the sequence of probe C and probes 1–5 were derived from the
histone H3 1–15 amino acids residues, the sequence of probe 6 was derived from the histone H4 1–19 amino acids residues.
(c) Schematic for the CLASPI strategy to profile proteins that bind certain histone mark in whole-cell proteomes

http://ars.els-cdn.com/content/image/1-s2.0-S1367593114001562-gr2.sml

Consistent with our findings, Tate and coworkers [57] recently reported the development of a photoaffinity probe based on a succinylated glutamate dehydrogenase (GDH) peptide for capturing Sirt5
as the corresponding desuccinylase. In addition to the application of photo-cross-linking strategy for examining the histone PTMs with known erasers, we recently used CLASPI with a photoaffinity
probe (probe 5, Figure 2b) to profile proteins that recognize a novel histone mark, crotonylation at histone H3K4 (H3K4cr, Table 1, Entry 6) [25], whose erasers were unknown. This study revealed,
for the first time, that Sirt3 can recognize the H3K4cr mark and efficiently catalyze the removal of histone crotonylation marks. More importantly, Sirt3 was found to regulate histone Kcr level in
cells and may potentially modulate gene transcription through its decrotonylase activity [58]. By converting bisubstrate inhibitors of HATs (histone peptides with certain lysine residues covalently
attached to Ac-CoA) to clickable photoaffinity probes (for example, probe 6, Figure 2b), they carried out the first systematic profiling of HATs in whole-cell proteomes [59].  We  anticipate  that  similar methods can be used to search for writers of novel histone PTMs such as Kmal, Ksucc, Kcr and Khib (Table 1) since the corresponding acyl-CoAs are presumed to be the acyl donors.

We have shown, in this review, the applications and recent advances of chemical tools, in combination with MS-based proteomics approaches, for the detection and characterization of histone
PTMs and their readers, erasers and writers.

This article belongs to a special issue

Omics Edited By Benjamin F Cravatt and Thomas Kodadek

Editorial overview: Omics: Methods to monitor and manipulate biological systems: recent advances in ‘omics’

Benjamin F Cravatt, Thomas Kodadek
Current Opinion in Chemical Biology Feb 2015; 24:v–vii
http://dx.doi.org/10.1016/j.cbpa.2014.12.023

7.3.3 Misfolded Proteins – from Little Villains to Little Helpers… Against Cancer

Ansgar Brüning1,* and Julia Jückstock
Front Oncol. 2015; 5: 47
http://dx.doi.org/10.3389.2Ffonc.2015.00047

The application of cytostatic drugs targeting the high proliferation rates of cancer cells is currently the most commonly used treatment option in cancer chemotherapy. However, severe side effects and resistance mechanisms may occur as a result of such treatment, possibly limiting the therapeutic efficacy of these agents. In recent years, several therapeutic strategies have been developed that aim at targeting not the genomic integrity and replication machinery of cancer cells but instead their protein homeostasis. During malignant transformation, the cancer cell proteome develops vast aberrations in the expression of mutated proteins, oncoproteins, drug- and apoptosis-resistance proteins, etc. A complex network of protein quality-control mechanisms, including chaperoning by heat shock proteins (HSPs), not only is essential for maintaining the extravagant proteomic lifestyle of cancer cells but also represents an ideal cancer-specific target to be tackled. Furthermore, the high rate of protein synthesis and turnover in certain types of cancer cells can be specifically directed by interfering with the proteasomal and autophagosomal protein recycling and degradation machinery, as evidenced by the clinical application of proteasome inhibitors. Since proteins with loss of their native conformation are prone to unspecific aggregations and have proved to be detrimental to normal cellular function, specific induction of misfolded proteins by HSP inhibitors, proteasome inhibitors, hyperthermia, or inducers of endoplasmic reticulum stress represents a new method of cancer cell killing exploitable for therapeutic purposes. This review describes drugs – approved, repurposed, or under investigation – that can be used to accumulate misfolded proteins in cancer cells, and particularly focuses on the molecular aspects that lead to the cytotoxicity of misfolded proteins in cancer cells.

Introduction:

How Do Proteins Fold and What Makes Misfolded Proteins Dangerous?

For an understanding of misfolded proteins, it is necessary to understand how cellular proteins attain and then further maintain their native conformation and how mature proteins and unfolded proteins are generated and converted into each other.

The principles and mechanisms of protein folding were one of the major research topics and achievements of biochemical research in the last century. For decades, Anfinsen’s model, which explained protein structure by thermodynamic principles applying to the polypeptide’s inherent amino acid sequence (1), was to be found in the introductory sections of all textbooks in protein biochemistry. According to Anfinsen’s thermodynamic hypothesis, the structure with the lowest conformational Gibbs free energy was finally taken by each single polypeptide due to a thermodynamic and stereochemical selection for side chain relations that form most stable and effective enzymes or structural proteins (1). Beyond this individual selection for the energetically most optimized conformation, evolution also selected for amino acid sequences that energetically allowed the smoothest and most “frustration-free” folding processes via a thermodynamic “folding funnel” (1–3).

Whereas Anfinsen’s model preferred the side chain elements as preferential organizing structures, recent hypotheses have inversely proposed the backbone hydrogen bonds as the driving force behind protein folding (4). According to the former theory, the finally folded protein was assumed to attain a single defined structure and shape (1, 4), and the unfolded conditions were described as being represented by a structureless statistical coil with nearly indefinite conformations – a so-called “featureless energy landscape” (4). The latter model assumes that a protein selects during its folding process from a limited repertoire of stable scaffolds of backbone hydrogen bond-satisfied α-helices and β-strands (4). This also implies that unfolded proteins are not structureless, shoelace-like linear amino acid alignments as often depicted in cartoons for graphical reasons, but actually, at least in part, retain discrete and stable scaffolds.

Once the protein has attained its final conformation, the problem of stabilizing this structure arises. Hydrophobic interactions that press non-polar side chains into the center of the protein are assumed to be a major force in protein stabilization (5, 6). At the protein surface, polar interactions, mainly by hydrogen bonds of polar side chains and backbone structure, are assumed to be of similar importance (6). Salt bridges and covalent disulfide bonds were identified as further forces supporting the stability of proteins (6). Accordingly, all conditions that interfere with these stabilizing forces, including extreme temperature, salt concentrations, and redox conditions, may lead to protein misfolding.

Another aspect that must be taken into account when studying protein folding relates to the very different conditions found in viable cells when compared to test tube conditions. Considering the life-cycle of a protein, each protein begins as a growing polypeptide chain protruding from the ribosomal exit tunnel and with several of its future interacting amino acid binding partners not even yet attached to the growing chain of the nascent polymer. In these ribosomal exit tunnels, first molecular interactions and helical structures are formed, and evidence exists to support the notion that the speed of translation is regulated by slow translating codon sequences just to optimize these first folding processes (7). After leaving the ribosomal tunnel, nascent polypeptides are also directly welcomed by chaperoning protein complexes, which facilitate and further guide the folding process of newly synthesized proteins (8). It is believed that a high percentage of nascent proteins are subject to immediate degradation due to early folding errors (9). Since many nascent proteins are synthesized in parallel at polysomes, the temporal and spatial proximity of unfolded peptides brings the additional risk of protein aggregation (10). Moreover, as mentioned above, even incomplete folding intermediates and partially folded states may form energetically but not physiologically active metastable structures (11, 12). An immediate, perinatal guidance and chaperoning of newborn proteins is therefore essential to creating functional, integrative proteins and to avoiding misfolded, function-less polypeptides with potentially cytotoxic features.

Since protein structure and function are coupled, misfolded proteins are, at first, loss-of-function proteins that might reduce cell viability, in particular when generated in larger quantities. A more dangerous feature of misfolded proteins, however, lies in their strong tendency toward abnormal protein–protein interactions or aggregations, which is reflected by the involvement of misfolded proteins and their aggregates in several amyloidotic diseases, including neurodegenerative syndromes such as Alzheimer’s disease and Parkinson’s disease (13, 14). The fact that several of these intracellular and extracellular protein aggregates contain β-sheet-like structures and form filamentous structures also supports the notion that misfolded proteins are not necessarily structureless protein coils or unspecific aggregates, at least when they are formed by homogenous proteins as in the case of several neurodegenerative diseases (13). Paradoxically, these larger aggregates appear to reflect a cell protective mechanism so as to sequester or segregate smaller, but highly reactive, nucleation cores of condensing protein aggregates (13).

Unspecific hydrophobic interactions, in particular, have been held responsible for protein aggregations that form when terminally folded proteins lose their native conformation and expose buried hydrophobic side chains on their surface (15, 16). These hydrophobic interactions are also believed to be the most problematic issues with newly synthesized polypeptides on single ribosomes or polysomes (12). Once exposed to the surface, the hydrophobic structures will quickly find possible interaction partners. The intracellular milieu can be regarded as a “crowded environment” (17), fully packed with proteins in close contact and near to their solubility limit (8, 12). Thus, misfolded proteins not only aggregate among each other but may also attach to normal native proteins and inhibit their function and activity. Since such misfolding effects and interactions can also include nuclear DNA replication and repair enzymes (18), misfolded proteins may not only exert proteotoxic but also genotoxic effects, thereby endangering the entire cellular “interactome” (19) by interfering both with the integrity of the proteome (proteostasis) and the genome. Therefore, a misfolded protein is not simply a loss-of-function protein but also a promiscuous little villain that might act like a free radical, exerting uncontrolled danger to the cell.

The way in which cells deal with misfolded proteins strongly depends on the nature, strength, length, and location of the damage induced by the various insults. Management of misfolded proteins can be achieved by heat shock protein (HSP)-mediated protein renaturation (repair); proteasomal, lysosomal, or autophagosomal degradation (recycling); intracellular disposal (aggregation); or – in its last consequence if overwhelmed – by programed cell death (despair). In the following paragraphs, the cellular management of misfolded proteins is described and therapeutic options to induce misfolded proteins in cancer cells are presented.

Hsp90 and Hsp90 Inhibitors

The best-known and evolutionarily most-conserved mechanism to protect against protein misfolding is the binding and refolding process mediated by so-called heat shock proteins (HSPs). HSPs recognize unfolded or misfolded proteins and facilitate their restructuring in either an ATP-dependent (large HSPs) or energy-independent manner (low weight HSPs). HSP of 90 kDa (hsp90) is a constitutively expressed HSP and is regarded as the most common and abundantly expressed HSP in eukaryotic cells (20, 21). Although commonly referred to as hsp90, it consists of a variety of isoforms that are encoding for cytosolic (hsp90α1, α2, β), mitochondrial (TRAP1), or endoplasmic reticulum (ER)-resident (GRP94) forms. Its primary function is less that of a stress response protein and more to bind to a certain group of client proteins unable to maintain a stable configuration without being assisted by hsp90 (20, 22, 23). Steroid hormone receptors (estrogen receptor, glucocorticoid receptor), cell cycle regulatory proteins (CDK4, cyclin D, polo-like kinase), and growth factor receptors and their downstream targets (epidermal growth factor receptor 1, HER2, AKT) are among the best-studied client proteins of hsp90 (20–22). Also, several cancer-specific mutations generating otherwise instable oncoproteins, such as mutant p53 or bcr-abl, rely on hsp90 chaperoning to keep them in a soluble form, thereby facilitating the extravagant but vulnerable “malignant lifestyle” of hsp90-addicted cancer cells (21, 24). Accordingly, hsp90 has been assumed to be a prominent target, in particular for hormone-responsive and growth factor receptor amplification-dependent cancer types.

The microbial antibiotics geldanamycin and radicicol are the prototypes of hsp90 inhibitors. Based on intolerable toxicity, these molecules had to be chemically modified for application in humans, and most of the ongoing clinical studies with hsp90 inhibitors are aimed at identifying semi-synthetic derivatives of these lead compounds with an acceptable risk profile. Unfortunately, most recent studies using geldanamycin derivatives have provided disappointing results because of toxicities and insufficient efficacy (22, 25–27). Studies with radicicol (resorcinol) derivatives, in particular with ganetespib, appear to be more promising because of fewer adverse effects (22, 25–27). Liver and ocular (retinal) toxicities have been described as main adverse effects of hsp90 inhibition, and appeared to be experienced less with ganetespib than with most of the first generation hsp90 inhibitors (28).

Since both geldanamycin and radicicol target the highly conserved and unique ATP-binding domain of hsp90, new synthetic inhibitors have also been generated by rational drug design (22, 25–27). However, none of the various natural or synthetic hsp90 inhibitors under investigation have yet provided convincing clinical data, and future studies will show whether hsp90 can eventually be added to the list of effective cancer targets.

Hsp70, Hsp40, Hsp27, and HSF1

Hsp90 is assisted by several other HSPs and non-chaperoning co-factors, finally forming a large protein complex that recruits and releases client proteins in an energy-dependent manner (21, 22, 29). Client proteins for hsp90 are first bound to hsp70, which transfers the prospective client to hsp90 through the mediating help of an hsp70–hsp90 organizing protein (HOP). Binding of potential hsp90 client proteins to hsp70 is facilitated by its co-chaperone hsp40 (23, 30). Exposed hydrophobic amino acids, the typical feature of misfolded proteins, have been described as the main recognition signal for hsp70 proteins (15, 16, 31). Hsp70 proteins are not only supporter proteins for hsp90 but also represent a large chaperone family capable of acting independently of hsp90 and that can be found in all cellular compartments, including cytosol and nucleus (hsp70, hsp72, hsc70), mitochondria (GRP75 = mortalin), and the ER (GRP78 = BiP). Hsp70 chaperones may act on misfolded or nascent proteins either as “holders” or “folders” (31), which means that they prevent protein aggregation either by sheltering these aggregation-prone protein intermediates or by allowing these proteins to fold/refold into their native form in an assisted mechanism within a protected environment (31). Hsc70 (HSPA8) is a constitutively expressed major hsp70 isoform that is an essential factor for normal protein homeostasis even in unstressed cells (16). Misfolded proteins can also be destined by hsp70 proteins for their ultimate degradation. Proteins that expose KFERQ amino acid motifs on their surface during their unfolding process are preferentially bound by hsc70 and can be directed to lysosomes in a process called chaperone-mediated autophagy (CMA) (32, 33). In another mechanism of targeted protein degradation, interaction of hsc70 with the E3 ubiquitin ligase CHIP (carboxyl terminus of Hsc70-interacting protein) leads to ubiquitination of misfolded proteins and thus their destination of the ubiquitin-proteasome protein degradation pathway (34, 35). Since hsc70 is essential for normal protein homeostasis and its knock-out is lethal in mice (16, 36), hsc70 inhibition might not be an optimal target for cancer-specific induction of misfolded proteins. This contrasts with the inducible forms of hsp70 such as hsp72 (HSPA1), which are upregulated in a cell stress-specific manner and are often found to be constitutively overexpressed in cancer tissues (16, 36). Transcriptional activation of these inducible HSPs is mediated by the heat shock factor 1 (HSF1), which also regulates expression of hsp40 and the small HSP hsp27 by sharing a common promoter consensus sequence (heat shock response element) for HSF1 binding (37). HSF1 was also found to be constitutively activated in cancer tissues, modulating several cell cycle- and apoptosis-related pathways via its target genes (38–40). HSF1 itself is kept inactive in the cytosol by binding to hsp90, and the recruitment of hsp90 to misfolded proteins is considered a main activation mechanism to release monomeric HSF1 for its subsequent trimerization, post-translational activation, and nuclear translocation (24, 41). Also, since hsp90 inhibition causes hsp70 induction by HSF1 activation as a compensatory feed-back mechanism (24), combined inhibition of hsp90 and hsp70, or of hsp90 and HSF1 might be a more effective therapeutic approach for cancer treatment than single HSP targeting alone.

Indeed, several small-molecule inhibitors and aptamers for hsp70, hsp40, and hsp27 have been designed (16, 42–44), but most of them remain in pre-clinical development, or are either not applicable in humans or associated with intolerable side effects (16, 42–44). Notably, the natural bioflavonoid quercetin was shown to inhibit phosphorylation and transcriptional activity of the heat shock transcription factor HSF1, thus reducing HSP expression at its most basal level (45–48). This HSP and HSF1 inhibition may also contribute to the observed cancer-preventing effects of a flavonoid-rich diet, which includes fruits and vegetables. However, due to their low bioavailability, the concentrations of flavonoids needed to induce direct cytotoxic effects in cancer cells for (chemo-)therapeutic reasons are obviously not achievable in humans, even when applied as nutritional supplements (49). More effective and clinically more easily applicable inhibitors of HSF1 are therefore urgently sought. Promising HSF1 targeting strategies are currently under development, although are apparently not yet suited for clinical applications (24, 50, 51).

SP Williams Comment:

There is a new hsp90- inhibitor, ganetespib, which is active against ovarian cancer in vitro and in vivo. Clinical trials are looking at this in cisplatin refractory cases. This was identified by a network analysis from a previous siRNA screen on ovarian cancer cells for pathways related to growth inhibition in an effort to find possible targets against CP resistance. The reference ishttp://www.researchgate.net/publication/253647952_Network_analysis_identifies_an_HSP90-central_hub_susceptible_in_ovarian_cancer

Protein Ubiquitination and Proteasomal Degradation

Ubiquitin is a 76 amino acid polypeptide that can covalently be attached via its carboxy-terminus to free (lysyl) amino groups of proteins. Ubiquitination of proteins generates a cellular recognition motif that is involved in various functions ranging from transcription factor and protein kinase activation to DNA repair and protein degradation – depending on the extent and exact location of this post-translational modification (52, 53). Monoubiquitination of peptides of more than 20 amino acids was found to be a minimal requirement for protein degradation, but the canonical fourfold (poly-)ubiquitination with three further lysine (K48) side chain-linked ubiquitins appears to be most apt for an effective and rapid substrate recognition by the proteasome (54). This canonical polyubiquitin structure, as well as several other mixed polyubiquitin structures, can be recognized by the external 19S subunits of the 26S proteasome complex (54, 55). Prior to degradation of ubiquitinated proteins by the proteasomal 20S core subunit, the attached ubiquitin chains are released by the external 19S subunits for recycling, although they can also be co-degraded by the proteasome (56). After first passing the 19S subunit, the proteasomal target proteins are then unfolded in an energy-dependent manner and introduced into the narrow enzymatic cavity of proteasome for degradation. The barrel-shaped 20S proteasomal core complex contains three different proteolytic activities in duplicate (β1: caspase-like-, β2: tryptic-, and β5: chymotryptic activity), which initiate an efficient cleavage of the proteasomal target proteins into smaller peptides (57).

It is important to note that specific ubiquitination and ensuing proteasomal degradation is not an exclusive degradation mechanism of misfolded proteins but is also used to regulate the expression level of several native cell cycle regulatory proteins [cyclins, proliferating cell nuclear antigen (PCNA), p53], signaling pathway molecules (β-catenin, IκB), and survival factors (mcl-1) during the course of normal protein homeostasis and cell cycle progression (53, 55, 57, 58). Moreover, proteasomes are involved in protein maturation, including the processing and maturation of the NF-κB transcription factor subunit p50 and the drug-resistant protein MDR1 (57). Therefore, targeting proteasomal activity has not only been of interest for the generation of misfolded, cytotoxic proteins but also for interfering with the expression of proteins involved in several hallmarks of cancer, including cell cycle progression, signal transduction, and apoptosis.

Proteasome Inhibitors

Bortezomib (PS-341, Velcade ™) has long been known as a paragon of a clinically applicable proteasome inhibitor. Bortezomib has been approved for the treatment of multiple myeloma and mantle cell lymphoma (55, 59, 60). The great expectations of transferring the success of bortezomib to non-hematological solid cancer types have unfortunately not yet been fulfilled. It has been suggested that the high antibody-producing capacity of myeloma cells and thus the need for an efficient proteasomal degradation system to cope with the recycling process of misfolded ER-generated antibodies [ER-associated degradation process (ERAD); see below] might contribute to the high sensitivity of myeloma cells to bortezomib (9, 60, 61). Originally, bortezomib was developed to inhibit the proteasomal degradation of the NF-κB inhibitor IκB, thus targeting the pro-inflammatory, but also cancer-promoting, effect of the NF-κB transcription factor (55, 60, 62). Recent insights indicate that the anti-tumoral effect of bortezomib is not only mediated by its NF-κB inhibitory activity but also by its ability to induce accumulation of misfolded proteins in the cytosol and the ER (60, 62–65). However, the use of bortezomib, even for highly sensitive multiple myeloma, is limited by its strong tendency to induce a proteasome inhibition-independent peripheral neuropathy by acting on neuronal mitochondria (61). Since neurodegenerative diseases are associated with protein misfolding and aggregation, the neuropathological effects of bortezomib might also be assumed to be mediated by the possible proteotoxic effects of bortezomib in neuronal cells. However, although proteasome inhibitor-induced neurodegeneration and inclusion body formation have been described in animal models, similarities between proteasome inhibitor-induced neurodegeneration and Parkinson’s disease-like histopathological features could not be established (66).

Table 1 Drugs described in this review and their mechanism of action (MOA), status of approval, and main adverse effects.

Aggresome Formation and Re-Solubilization: Role of HDAC6

As depicted above, proteasome and HSP inhibition will eventually lead to the accumulation of misfolded and polyubiquitinated proteins. Based on their inherent cohesive properties mediated by their exposed hydrophobic surfaces, both ubiquitinated and non-ubiquitinated misfolded proteins tend to adhere as small aggregates (Figure ​(Figure1).1). Individual ubiquitinated proteins and small ubiquitinated aggregates can be recognized by specific ubiquitin-binding proteins such as HDAC6 via its zinc finger ubiquitin-binding domain. HDAC6 is an unusual histone deacetylase located in the cytosol that regulates microtubule acetylation and is also able to bind ubiquitinated proteins. Based on HDAC6’s additional ability to bind to microtubule motor protein dynein, these aggregates are actively transported along the microtubular system into perinuclear aggregates around the microtubule organizing center (MTOC) (108384). Recognition of small, scattered ubiquitinated aggregates by HDAC6 has been described as being mediated by unanchored ubiquitin chains, which are generated by aggregate-attached ubiquitin ligase ataxin-3 (85). Whereas proteasomal target proteins are primarily tagged by K-48 (lysine-48) linked ubiquitins; K-63 linked ubiquitin chains appear to be a preferential modification for aggresomal targeting by HDAC6 and were assumed to mediate a redirection from proteasomal degradation to aggresome formation in the case of proteasomal inhibition or overload (86). Accordingly, aggresome formation is not an unspecific protein aggregation but a specific, ubiquitin-controlled sorting process. Furthermore, these aggresomes consist not only of misfolded and deposited proteins but have also been shown to contain a large amount of associated HSPs and ubiquitin-binding proteins, including HDAC6 [Figure ​[Figure1;1; (108384)]. Aggresomes contain, and are also surrounded by, large numbers of proteasomes (108384), which help to resolubilize these aggregates not only through their intrinsic proteasomal digestion but also by generating unanchored K63-branched polyubiquitin chains, which then stimulate HDAC6-mediated autophagy, another cellular disposal mechanism in involving HDAC6 (87). Notably, HDAC6 has also been shown to control further maturation of autophagic vesicles by stimulating autophagosome–lysosome fusion (Figure ​(Figure1)1) in a manner different from the normal autophagosome–lysosome fusion process (88).

Figure 1

Drugs that inhibit folding or disposal of misfolded proteins. Native mature proteins, nascent proteins, or misfolded proteins can be prevented from folding or refolding by small and large heat shock protein inhibitors, of which the hsp90 inhibitors based 

The HDAC6 multitalent also exerts its deacetylase activity on hsp90 and modifies hsp90 client binding by facilitating its chaperoning of steroid hormone receptors and HSF1 (8991). Recruitment of HDAC6 to ubiquitinated proteins leads to the dissociation of the repressive HDAC6/hsp90/HSF1 complex (91) and allows the release of transcriptionally active HSF1 to the nucleus. The engagement of HDAC6 at the aggresome–autophagy pathway hence also indirectly facilitates HSF1 activity. p97/VCP (valosin-containing protein), another binding partner of HDAC6 and itself a multi-interactive, ATP-dependent chaperone (9294), is assumed to be involved not only in the specific separation of hsp90 and HSF1 by its “segregase” activity but also in the binding and remodeling of polyubiquitinated proteins before their delivery to the proteasome (9395). Additionally, p97/VCP dissociates polyubiquitinated proteins bound to HDAC6 (91). Accumulation of polyubiquitinated proteins thus leads to HDAC6-dependent HSF1 activation and HSP induction, p97/VCP-dependent recruitment and “preparation” of polyubiquitinated proteins to proteasomes, and, in the case of pharmacological proteasome inhibition or physiological overload, to an HDAC6-dependent detoxification of polyubiquitinated proteins by the aggresome/autophagy pathway.

Pharmacological Inhibition of Aggresome Formation: HDAC6 Inhibitors

The central involvement of HDAC6 in aggresome formation and clearance makes HDAC6 one of the most interesting druggable targets for the induction of proteotoxicity in cancer cells. Also, HDAC6 has been found to be overexpressed in various cancer tissues, associated with advanced cancer stages and increased neoplastic transformation (96). Several pan-histone deacetylase inhibitors have been developed and tested in clinical studies for a variety of diseases, including different types of cancer (9798). Although hematological malignancies responded best to most of the already clinically tested pan-histone deacetylase inhibitors, the efficacy on solid cancer types was disappointingly poor and also associated with intolerable side effects (98). The unforeseeable pleiotropic epigenetic mechanism caused by non-specific (nuclear) histone deacetylase inhibitors may also limit their application for use in cancer treatment or HDAC6 inhibition, and has led to the search for selective HDAC6 inhibitors with no inhibitory effects on transcription modifying histone deacetylases. Through screening of small molecules under the rationale of selecting for tubulin deacetylase inhibitors with no cross-reactive histone deacetylase activity, the HDAC6 inhibitor tubacin was identified, and suggested for use in the treatment of neurodegenerative diseases or to reduce cancer cell migration and angiogenesis (99). Hideshima et al. then proved the hypothesis that the combined use of bortezomib with tubacin leads to an accumulation of non-disposed cytotoxic proteins and aggregates in cancer cells (100). Indeed, a synergistic effect of these two drugs against multiple myeloma cells could be observed with no detectable toxic effect on peripheral blood mononuclear cells (100). This and follow-up studies also revealed the efficacy of tubacin as a single agent against leukemia cells (100101) and a chemo-sensitizing effect on cytotoxic drugs in breast- and prostate-cancer cells (102).

Endoplasmic Reticulum Stress

Besides the cytosol, the ER is a major site for protein synthesis, in particular for those proteins destined for extracellular secretion, the cell membrane, or their retention within the endomembrane system. At the rough ER, nascent proteins are co-translationally transported across the ER membrane into the ER lumen (107), where they immediately encounter ER-resident chaperones, most prominently represented by hsp70 family member BiP/GRP78 and hsp90 family member GRP94 to help proper protein folding (15108). Most of these proteins also undergo post-translational modifications, including N- or O-linked glycosylation or protein disulfide bridge-building (109110), thereby adding further mechanisms of protein stabilization but also challenges for proper protein folding.

Similar to the situation in cytosolic protein biosynthesis, a large proportion of nascent proteins in the ER are assumed to misfold and to go “off-pathway” even under normal physiological conditions. Furthermore, the ER lumen, narrowly sandwiched between two phospholipid membranes, has been described as an even more densely crowded environment than the cytosol, additionally facilitating unspecific protein attachments and aggregations (15). Since, with the exception of bulk reticulophagy, the lumen of the ER contains no endogenous protein degradation system, and the anterograde transport of ER proteins to the Golgi, lysosomes, endosomes, or the extracellular environment requires properly folded proteins, a retrograde transport of ER proteins into the cytosol remains the only possible mechanism of preventing misfolded protein accumulation within the ER. In this ERAD, misfolded proteins are re-exported across the ER membrane by a specific multi protein complex, ubiquitinated by ER membrane-integrated ubiquitin ligases, and finally become degraded by cytosolic proteasomes (111112). Notably, association of the cytosolic p97/VCP protein, an important interacting partner with HDAC6, has also been described as being an essential factor for driving the luminal proteins through the ER membrane pore complex into the cytosol (92,112).

Accordingly, all agents and conditions that interfere with these folding, maturation, and retranslocation processes can lead to protein misfolding and aggregation within this sensitive organelle. Chemicals that act as glycosylation inhibitors (tunicamycin), calcium ionophore inhibitors (A23187, thapsigargin), heavy metal ions (cadmium, lead), reducing agents (dithiothreitol), as well as conditions like hypoxia or oxidative stress, all lead to a phenomenon called ER stress (113116). In the ER-stress response, a triad of ER membrane-resident signaling receptors and transducers, IRE1, ATF6, and PERK1, become activated and lead to the transcriptional activation of cytosolic and ER-resident chaperones to cope with the increasing number of misfolded proteins. Induction of autophagy (reticulophagy; ER-phagy) may also occur and supports the removal of damaged regions of the ER (117). Under very intensive or even unmanageable ER-stress conditions, a variety of pro-apoptotic pathways ensue, including CHOP induction, c-JUN-kinase activation, and caspase cleavage (118120), which eventually prevails over the cytoprotective arm of the ER-stress response and may lead to apoptosis. Targeting of protein folding within the ER is therefore a very promising strategy to induce apoptosis in cancer cells, in particular in those cancer cells characterized by an unphysiologically high protein secretion rate, such as, for example, multiple myeloma cells. Whereas the above-mentioned drugs such as tunicamycin or thapsigargin are valuable tools for cell biology studies, they display unacceptable toxicities in humans and are not suited for therapeutic applications. Interestingly, several already established drugs used for non-cancerous diseases have been described as inducing ER stress at pharmacologically relevant concentrations in humans as an off-target effect (113116). The non-steroidal anti-inflammatory COX-2 inhibitor celecoxib is an approved drug to treat various forms of arthritis and pain, but has also been described as exerting ER stress by functioning as a SERCA (sarco/ER Ca2+ ATPase) inhibitor (113116). However, although well tolerated in humans, the ER-stress-inducing ability of celecoxib seems to be weaker than that of direct SERCA inhibitors such as thapsigargin, and the usefulness of celecoxib against advanced cancer has been questioned (116). Various HIV protease inhibitors have been described as inducing ER stress in human tissue cells as a side effect (121123). In particular the HIV drugs lopinavir, saquinavir, and nelfinavir appear to be potent inducers of the ER-stress reaction, leading to a focused interest in these drugs for the induction of ER stress and apoptosis in cancer cells (116124128). In fact, with currently over 27 clinical studies in cancer patients2, nelfinavir, either used as a single agent or in combination therapy, is on the list of the most promising prospective candidates to induce selective proteotoxicity in cancer cells at pharmacologically relevant concentrations. Although the exact mechanism by which nelfinavir induces ER stress is not yet clear, it was shown that nelfinavir causes the upregulation of cytosolic and ER-resident HSPs, and induces apoptosis in cancer cells associated with caspase activation and induction of the pro-apoptotic transcription factor CHOP (125126). Nelfinavir was also shown to be combinable with bortezomib to enhance its activity on cancer cells (129). Since the retrograde transport of misfolded ER proteins is inhibited by the p97/VCP inhibitor eeyarestatin (130131), we recently tested the combination of eeyarestatin with nelfinavir but found no synergistic effect between these two agents in cervical cancer cells (132). In contrast, eeyarestatin markedly sensitized cervical cancer cells to bortezomib treatment (132), which was also observed in preceding studies in which eeyarestatin was used to augment the ER-stress-inducing ability of bortezomib in leukemia cells (131).

Induction of proteotoxicity through the accumulation of misfolded proteins has evolved as a new treatment modality in the fight against cancer. Clinically approved drugs such as bortezomib and carfilzomib provide evidence of the functionality of this approach. Newly developed agents like the HDAC6 inhibitor ACY-1215 or repurposed drugs like nelfinavir or disulfiram are currently being tested in clinical trials with cancer patients and will hopefully further broaden our arsenal of anti-cancer drugs. Notably, most proteotoxic agents that have been approved or are in clinical trials target the ubiquitin-proteasome-system (UPS) and are mainly effective in multiple myeloma cells, which rely on a functional ER/ERAD/UPS for excessive and proper antibody production. Similarly, it can be assumed that other cancer cell types with a marked secretory phenotype may also be affected by ER/ERAD/UPS inhibitors. In accordance with this notion, a recent dose-escalating Phase Ia study with nelfinavir as a single agent, that covered a large variety of solid cancer entities, revealed response rates primarily in patients with neuroendocrine tumors (140). In most other solid cancer types, however, the chemo-sensitizing or combination effects of proteotoxic drugs may prevail, and have become the focus of an increasing number of very promising clinical and pre-clinical studies.

7.3.4 Endoplasmic reticulum protein 29 (ERp29) in epithelial cancer

Friend or Foe: Endoplasmic reticulum protein 29 (ERp29) in epithelial cancer

Chen S1Zhang D2

FEBS Open Bio. 2015 Jan 30; 5:91-8
http://dx.doi.org:/10.1016/j.fob.2015.01.004

The endoplasmic reticulum (ER) protein 29 (ERp29) is a molecular chaperone that plays a critical role in protein secretion from the ER in eukaryotic cells. Recent studies have also shown that ERp29 plays a role in cancer. It has been demonstrated that ERp29 is inversely associated with primary tumor development and functions as a tumor suppressor by inducing cell growth arrest in breast cancer. However, ERp29 has also been reported to promote epithelial cell morphogenesis, cell survival against genotoxic stress and distant metastasis. In this review, we summarize the current understanding on the biological and pathological functions of ERp29 in cancer and discuss the pivotal aspects of ERp29 as “friend or foe” in epithelial cancer.

The endoplasmic reticulum (ER) is found in all eukaryotic cells and is complex membrane system constituting of an extensively interlinked network of membranous tubules, sacs and cisternae. It is the main subcellular organelle that transports different molecules to their subcellular destinations or to the cell surface [10,85].

The ER contains a number of molecular chaperones involved in protein synthesis and maturation. Of the ER chaperones, protein disulfide isomerase (PDI)-like proteins are characterized by the presence of a thioredoxin domain and function as oxido-reductases, isomerases and chaperones [33]. ERp29 lacks the active-site double-cysteine (CxxC) motif and does not belong to the redox-active PDIs [5,47]. ERp29 is recognized as a characterized resident of the cellular ER, and it is expressed ubiquitously and abundantly in mammalian tissues [50]. Protein structural analysis showed that ERp29 consists of N-terminal and C-terminal domains [5]: N-terminal domain involves dimerization whereas the C-terminal domain is essential for substrate binding and secretion [78]. The biological function of ERp29 in protein secretion has been well established in cells [8,63,67].

ERp29 is proposed to be involved in the unfolded protein response (UPR) as a factor facilitating transport of synthesized secretory proteins from the ER to Golgi [83]. The expression of ERp29 was demonstrated to be increased in cells exposed to radiation [108], sperm cells undergoing maturation [42,107], and in certain cell types both under the pharmacologically induced UPR and under the physiological conditions (e.g., lactation, differentiation of thyroid cells) [66,82]. Under ER stress, ERp29 translocates the precursor protein p90ATF6 from the ER to Golgi where it is cleaved to be a mature and active form p50ATF by protease (S1P and S2P) [48]. In most cases, ERp29 interacts with BiP/GRP78 to exert its function under ER stress [65].

ERp29 is considered to be a key player in both viral unfolding and secretion [63,67,77,78] Recent studies have also demonstrated that ERp29 is involved in intercellular communication by stabilizing the monomeric gap junction protein connexin43 [27] and trafficking of cystic fibrosis transmembrane conductance regulator to the plasma membrane in cystic fibrosis and non-cystic fibrosis epithelial cells [90]. It was recently reported that ERp29 directs epithelial Na(+) channel (ENaC) toward the Golgi, where it undergoes cleavage during its biogenesis and trafficking to the apical membrane [40]. ERp29 expression protects axotomized neurons from apoptosis and promotes neuronal regeneration [111]. These studies indicate a broad biological function of ERp29 in cells.

Recent studies demonstrated a tumor suppressive function of ERp29 in cancer. It was found that ERp29 expression inhibited tumor formation in mice [4,87] and the level of ERp29 in primary tumors is inversely associated with tumor development in breast, lung and gallbladder cancer [4,29].

However, its expression is also responsible for cancer cell survival against genotoxic stress induced by doxorubicin and radiation [34,76,109]. The most recent studies demonstrate other important roles of ERp29 in cancer cells such as the induction of mesenchymal–epithelial transition (MET) and epithelial morphogenesis [3,4]. MET is considered as an important process of transdifferentiation and restoration of epithelial phenotype during distant metastasis [23,52]. These findings implicate ERp29 in promoting the survival of cancer cells and also metastasis. Hence, the current review focuses on the novel functions of ERp29 and discusses its pathological importance as a “friend or foe” in epithelial cancer.

2. ERp29 regulates mesenchymal–epithelial transition

2.1. Epithelial–mesenchymal transition (EMT) and MET

The EMT is an essential process during embryogenesis [6] and tumor development [43,96]. The pathological conditions such as inflammation, organ fibrosis and cancer progression facilitate EMT [16]. The epithelial cells after undergoing EMT show typical features characterized as: (1) loss of adherens junctions (AJs) and tight junctions (TJs) and apical–basal polarity; (2) cytoskeletal reorganization and distribution; and (3) gain of aggressive phenotype of migration and invasion [98]. Therefore, EMT has been considered to be an important process in cancer progression and its pathological activation during tumor development induces primary tumor cells to metastasize [95]. However, recent studies showed that the EMT status was not unanimously correlated with poorer survival in cancer patients examined [92].

In addition to EMT in epithelial cells, mesenchymal-like cells have capability to regain a fully differentiated epithelial phenotype via the MET [6,35]. The key feature of MET is defined as a process of transdifferentiation of mesenchymal-like cells to polarized epithelial-like cells [23,52] and mediates the establishment of distant metastatic tumors at secondary sites [22]. Recent studies demonstrated that distant metastases in breast cancer expressed an equal or stronger E-cadherin signal than the respective primary tumors and the re-expression of E-cadherin was independent of the E-cadherin status of the primary tumors [58]. Similarly, it was found that E-cadherin is re-expressed in bone metastasis or distant metastatic tumors arising from E-cadherin-negative poorly differentiated primary breast carcinoma [81], or from E-cadherin-low primary tumors [25]. In prostate and bladder cancer cells, the nonmetastatic mesenchymal-like cells were interacted with metastatic epithelial-like cells to accelerate their metastatic colonization [20]. It is, therefore, suggested that the EMT/MET work co-operatively in driving metastasis.

2.2. Molecular regulation of EMT/MET

E-cadherin is considered to be a key molecule that provides the physical structure for both cell–cell attachment and recruitment of signaling complexes [75]. Loss of E-cadherin is a hallmark of EMT [53]. Therefore, characterizing transcriptional regulators of E-cadherin expression during EMT/MET has provided important insights into the molecular mechanisms underlying the loss of cell–cell adhesion and the acquisition of migratory properties during carcinoma progression [73].

Several known signaling pathways, such as those involving transforming growth factor-β (TGF-β), Notch, fibroblast growth factor and Wnt signaling pathways, have been shown to trigger epithelial dedifferentiation and EMT [28,97,110]. These signals repress transcription of epithelial genes, such as those encoding E-cadherin and cytokeratins, or activate transcription programs that facilitate fibroblast-like motility and invasion [73,97].

The involvement of microRNAs (miRNAs) in controlling EMT has been emphasized [11,12,18]. MiRNAs are small non-coding RNAs (∼23 nt) that silence gene expression by pairing to the 3′UTR of target mRNAs to cause their posttranscriptional repression [7]. MiRNAs can be characterized as “mesenchymal miRNA” and “epithelial miRNA” [68]. The “mesenchymal miRNA” plays an oncogenic role by promoting EMT in cancer cells. For instance, the well-known miR-21, miR-103/107 are EMT inducer by repressing Dicer and PTEN [44].

The miR-200 family has been shown to be major “epithelial miRNA” that regulate MET through silencing the EMT-transcriptional inducers ZEB1 and ZEB2 [13,17]. MiRNAs from this family are considered to be predisposing factors for cancer cell metastasis. For instance, the elevated levels of the epithelial miR-200 family in primary breast tumors associate with poorer outcomes and metastasis [57]. These findings support a potential role of “epithelial miRNAs” in MET to promote metastatic colonization [15].

2.3. ERp29 promotes MET in breast cancer

The role of ERp29 in regulating MET has been established in basal-like MDA-MB-231 breast cancer cells. It is known that myosin light chain (MLC) phosphorylation initiates to myosin-driven contraction, leading to reorganization of the actin cytoskeleton and formation of stress fibers [55,56]. ERp29 expression in this type of cells markedly reduced the level of phosphorylated MLC [3]. These results indicate that ERp29 regulates cortical actin formation through a mechanism involved in MLC phosphorylation (Fig. 1). In addition to the phenotypic change, ERp29 expression leads to: expression and membranous localization of epithelial cell marker E-cadherin; expression of epithelial differentiation marker cytokeratin 19; and loss of the mesenchymal cell marker vimentin and fibronectin [3] (Fig. 1). In contrast, knockdown of ERp29 in epithelial MCF-7 cells promotes acquisition of EMT traits including fibroblast-like phenotype, enhanced cell spreading, decreased expression of E-cadherin and increased expression of vimentin [3,4]. These findings further substantiate a role of ERp29 in modulating MET in breast cancer cells.

Fig. 1  ERp29 triggers mesenchymal–epithelial transition. Exogenous expression of ERp29 in mesenchymal MDA-MB-231 breast cancer cells inhibits stress fiber formation by suppressing MLC phosphorylation. In addition, the overexpressed ERp29 decreases the 

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2.4. ERp29 targets E-cadherin transcription repressors

The transcription repressors such as Snai1, Slug, ZEB1/2 and Twist have been considered to be the main regulators for E-cadherin expression [19,26,32]. Mechanistic studies revealed that ERp29 expression significantly down-regulated transcription of these repressors, leading to their reduced nuclear expression in MDA-MB-231 cells [3,4] (Fig. 2). Consistent with this, the extracellular signal-regulated kinase (ERK) pathway which is an important up-stream regulator of Slug and Ets1 was highly inhibited [4]. Apparently, ERp29 up-regulates the expressions of E-cadherin transcription repressors through repressing ERK pathway. Interestingly, ERp29 over-expression in basal-like BT549 cells resulted in incomplete MET and did not significantly affect the mRNA or protein expression of Snai1, ZEB2 and Twist, but increased the protein expression of Slug [3]. The differential regulation of these transcriptional repressors of E-cadherin by ERp29 in these two cell-types may occur in a cell-context-dependent manner.

Fig. 2  ERp29 decreases the expression of EMT inducers to promote MET. Exogenous expression of ERp29 in mesenchymal MDA-MB-231 breast cancer cells suppresses transcription and protein expression of E-cadherin transcription repressors (e.g., ZEB2, SNAI1 and Twist), ..

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2.5. ERp29 antagonizes Wnt/ β-catenin signaling

Wnt proteins are a family of highly conserved secreted cysteine-rich glycoproteins. The Wnt pathway is activated via a binding of a family member to a frizzled receptor (Fzd) and the LDL-Receptor-related protein co-receptor (LRP5/6). There are three different cascades that are activated by Wnt proteins: namely canonical/β-catenin-dependent pathway and two non-canonical/β-catenin-independent pathways that include Wnt/Ca2+ and planar cell polarity [84]. Of note, the Wnt/β-catenin pathway has been extensively studied, due to its important role in cancer initiation and progression [79]. The presence of Wnt promotes formation of a Wnt–Fzd–LRP complex, recruitment of the cytoplasmic protein Disheveled (Dvl) to Fzd and the LRP phosphorylation-dependent recruitment of Axin to the membrane, thereby leading to release of β-catenin from membrane and accumulation in cytoplasm and nuclei. Nuclear β-catenin replaces TLE/Groucho co-repressors and recruits co-activators to activate expression of Wnt target genes. The most important genes regulated are those related to proliferation, such as Cyclin D1 and c-Myc [46,94], which are over-expressed in most β-catenin-dependent tumors. When β-catenin is absent in nucleus, the transcription factors T-cell factor/lymphoid enhancer factors (TCF/LEF) recruits co-repressors of the TLE/Groucho family and function as transcriptional repressors.

β-catenin is highly expressed in the nucleus of mesenchymal MDA-MB-231 cells. ERp29 over-expression in this type of cells led to translocation of nuclear β-catenin to membrane where it forms complex with E-cadherin [3] (Fig. 3). This causes a disruption of β-catenin/TCF/LEF complex and abolishes its transcription activity. Indeed, ERp29 significantly decreased the expression of cyclin D1/D2 [36], one of the downstream targets of activated Wnt/β-catenin signaling [94], indicating an inhibitory effect of ERp29 on this pathway. Meanwhile, expression of ERp29 in this cell type increased the nuclear expression of TCF3, a transcription factor regulating cancer cell differentiation while inhibiting self-renewal of cancer stem cells [102,106]. Hence, ERp29 may play dual functions in mesenchymal MDA-MB-231 breast cancer cells by: (1) suppressing activated Wnt/β-catenin signaling via β-catenin translocation; and (2) promoting cell differentiation via activating TCF3 (Fig. 3). Because β-catenin serves as a signaling hub for the Wnt pathway, it is particularly important to focus on β-catenin as the target of choice in Wnt-driven cancers. Though the mechanism by which ERp29 expression promotes the disassociation of β-catenin/TCF/LEF complex in MDA-MB-231 cells remains elusive, activating ERp29 expression may exert an inhibitory effect on the poorly differentiated, Wnt-driven tumors.

Fig. 3  ERp29 over-expression “turns-off” activated Wnt/β-catenin signaling. In mesenchymal MDA-MB-231 cells, high expression of nuclear β-catenin activates its downstream signaling involved in cell cycles and cancer stem cell 

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3. ERp29 regulates epithelial cell integrity

3.1. Cell adherens and tight junctions

Adherens junctions (AJs) and tight junctions (TJs) are composed of transmembrane proteins that adhere to similar proteins in the adjacent cell [69]. The transmembrane region of the TJs is composed mainly of claudins, tetraspan proteins with two extracellular loops [1]. AJs are mediated by Ca2+-dependent homophilic interactions of cadherins [71] which interact with cytoplasmic catenins that link the cadherin/catenin complex to the actin cytoskeleton [74].

The cytoplasmic domain of claudins in TJs interacts with occludin and several zona occludens proteins (ZO1-3) to form the plaque that associates with the cytoskeleton [99]. The AJs form and maintain intercellular adhesion, whereas the TJs serve as a diffusion barrier for solutes and define the boundary between apical and basolateral membrane domains [21]. The AJs and TJs are required for integrity of the epithelial phenotype, as well as for epithelial cells to function as a tissue [75].

The TJs are closely linked to the proper polarization of cells for the establishment of epithelial architecture[86]. During cancer development, epithelial cells lose the capability to form TJs and correct apico–basal polarity [59]. This subsequently causes the loss of contact inhibition of cell growth [91]. In addition, reduction of ZO-1 and occludin were found to be correlated with poorly defined differentiation, higher metastatic frequency and lower survival rates [49,64]. Hence, TJs proteins have a tumor suppressive function in cancer formation and progression.

3.2. Apical–basal cell polarity

The apical–basal polarity of epithelial cells in an epithelium is characterized by the presence of two specialized plasma membrane domains: namely, the apical surface and basolateral surface [30]. In general, the epithelial cell polarity is determined by three core complexes. These protein complexes include: (1) the partitioning-defective (PAR) complex; (2) the Crumbs (CRB) complex; and (3) the Scribble complex[2,30,45,51]. PAR complex is composed of two scaffold proteins (PAR6 and PAR3) and an atypical protein kinase C (aPKC) and is localized to the apical junction domain for the assembly of TJs [31,39]. The Crumbs complex is formed by the transmembrane protein Crumbs and the cytoplasmic scaffolding proteins such as the homologue of Drosophila Stardust (Pals1) and Pals-associated tight junction protein (Patj) and localizes to the apical [38]. The Scribble complex is comprised of three proteins, Scribble, Disc large (Dlg) and Lethal giant larvae (Lgl) and is localized in the basolateral domain of epithelial cells [100].

Fig. 4  ERp29 regulates epithelial cell morphogenesis. Over-expression of ERp29 in breast cancer cells induces the transition from a mesenchymal-like to epithelial-like phenotype and the restoration of tight junctions and cell polarity. Up-regulation and membrane 

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The current data from breast cancer cells supports the idea that ERp29 can function as a tumor suppressive protein, in terms of suppression of cell growth and primary tumor formation and inhibition of signaling pathways that facilitate EMT. Nevertheless, the significant role of ERp29 in cell survival against drugs, induction of cell differentiation and potential promotion of MET-related metastasis may lead us to re-assess its function in cancer progression, particularly in distant metastasis. Hence, it is important to explore in detail the ERp29’s role in cancer as a “friend or foe” and to elucidate its clinical significance in breast cancer and other epithelial cancers. Targeting ERp29 and/or its downstream molecules might be an alternative molecular therapeutic approach for chemo/radio-resistant metastatic cancer treatment

7.3.5 Putting together structures of epidermal growth factor receptors

Bessman NJ, Freed DM, Lemmon MA
Curr Opin Struct Biol. 2014 Dec; 29:95-101
http://dx.doi.org:/10.1016/j.sbi.2014.10.002

Highlights

  • Several studies suggest flexible linkage between extracellular and intracellular regions. • Others imply more rigid connections, required for allosteric regulation of dimers. • Interactions with membrane lipids play important roles in EGFR regulation. • Cellular studies suggest half-of-the-sites negative cooperativity for human EGFR.

Numerous crystal structures have been reported for the isolated extracellular region and tyrosine kinase domain of the epidermal growth factor receptor (EGFR) and its relatives, in different states of activation and bound to a variety of inhibitors used in cancer therapy. The next challenge is to put these structures together accurately in functional models of the intact receptor in its membrane environment. The intact EGFR has been studied using electron microscopy, chemical biology methods, biochemically, and computationally. The distinct approaches yield different impressions about the structural modes of communication between extracellular and intracellular regions. They highlight possible differences between ligands, and also underline the need to understand how the receptor interacts with the membrane itself.

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Growth factor receptor tyrosine kinases (RTKs) such as the epidermal growth factor receptor (EGFR) have been the subjects of intense study for many years [1,2]. There are 58 RTKs in the deduced human
proteome, and all play key roles in regulating cellular processes such as proliferation, differentiation, cell survival and metabolism, cell migration, and cell cycle control [3].  Importantly, aberrant activation
of RTK signaling by mutation, gene amplification, gene translocation or other mechanisms has been causally linked to cancers, diabetes, inflammation, and other diseases. These observations have prompted
the development of many targeted therapies that inhibit RTKs such as EGFR [4], Kit, VEGFR, or their ligands — typically employing therapeutic antibodies [5] or small molecule tyrosine kinase inhibitors [6].
Following the initial discoveries for EGFR [7] and the platelet-derived growth factor receptor (PDGFR) [8] that ligand-stabilized dimers are essential for RTK signaling, structural studies over the past decade
or so have guided development of quite sophisticated mechanistic views[1]. Each RTK has a ligand-binding extracellular region (ECR) that is linked by a single transmembrane a-helix to an intracellular
tyrosine kinase domain (TKD). Structures of the isolated ECRs and TKDs from several RTKs point to surprising mechanistic diversity across the larger family [1]. Unliganded RTKs exist as an equilibrium
mixture of inactive monomers, inactive dimers and active dimers (Figure 1), except for the extreme case of the insulin receptor (IR), which is covalently dimerized [9]. Extracellular ligand can bind to monomers,
to inactive dimers, or to active dimers — in each case pushing the equilibria shown in Figure 1 towards the central ligand-bound active dimer. Thus, ligand binding can drive receptor dimerization (Figure 1,
upper), or can promote inactive-to-active conformational transitions in dimers (Figure 1, lower). Regardless of pathway, the intracellular TKD of the ligand-stabilized dimer becomes activated either through
trans-autophosphorylation or through induced allosteric changes [1,10]. Roles for other parts of the receptor in RTK activation, including the juxtamembrane (JM) and transmembrane (TM) segments, have
also become clearer. The key current challenge for the field is to assemble data from many studies of isolated RTK parts into coherent views of how the intact receptors are regulated in their native membranes.
We will focus here on recent efforts to do this for the EGFR (or ErbB receptor) family. The missing links in intact RTKs: flexible or rigid? A central goal in extrapolating to the intact RTKs from studies of
isolated soluble domains is to understand how the individual parts of the receptor communicate with one another. The methods that have been used to produce and study the isolated domains inevitably
yield the impression that inter-domain linkers are flexible and disordered. For example, extracellular juxtamembrane regions have typically only been observed as C-terminal extensions of  the soluble ECR.
Similarly, intracellular juxtamembrane regions have been encountered predominantly as N-terminal extensions of TKD constructs, or as short peptides. In each of these contexts, the JM regions are incomplete,
and may appear disordered and flexible simply because key structural restraints have been removed. Nonetheless, this possible artifact has strongly influenced thinking about linkages between the extracellular
and intracellular regions [11], and in turn about mechanisms of RTK signaling. Highly flexible linkages between extracellular and intracellular regions of RTKs are fully consistent with simpler ligand-induced
dimerization models for transmembrane signaling by RTKs. It is more difficult, however, to understand how subtle allosteric communication across the membrane could be achieved if the linkages are truly
flexible. For example, since flexible linkage implies structural independence of the extracellular and intracellular regions, it is difficult to envision how a transition from inactive to active dimer in Figure 1
could be controlled precisely by ligand without more rigid (or restricted) connections.

Recent experimental studies with intact — or nearly intact — EGFR differ in the impressions they provide about how flexibly or rigidly the extracellular and intracellular regions are linked. Springer’s laboratory used cysteine crosslinking and mutagenesis approaches to investigate this issue for EGFR expressed in Ba/F3 cells [12]. They were unable to identify any specific JM or TM region interfaces
that were required for EGFR signaling, leading them to argue that the linkage across the membrane is too flexible to transmit a specific orientation between the extracellular and intracellular regions.
Consistent with this, negative-stain electron microscopy studies of (nearly) full-length EGFR in dodecylmaltoside micelles showed that a given extracellular dimer can be linked to several different
arrangements of the intracellular kinase domain [13,14]. Similarly, dimers driven by inhibitor binding to the intracellular TKD could couple to multiple different ECR conformations [13]. Biochemical
studies are also consistent with such structural independence of the extracellular and intracellular  regions [15,16]. Contrasting with these observations, however, Schepartz and colleagues have
reported that different precise conformations within the EGFR intracellular region can be induced by distinct activating ligands [17]. They used a method called bipartite tetracysteine display that
reports on formation of a chemically detectable tetracysteine motif when two cysteine pairs come together at  the dimer  interface. EGF activation of the receptor led to formation of a  tetracysteine
motif that requires the intracellular JM helix  [18] shown in Figure 2a to form antiparallel coiled-coil dimers  (Figure 2b/c) as proposed by Kuriyan and colleagues [19,20]. Surprisingly, transforming
growth factor-a (TGFa),which also activates EGFR, did not bring these two cysteine pairs together in the same way — arguing that TGFa does not induce formation of the same intracellular antiparallel
coiled-coil. Instead, activation of EGFR with TGFa (but not EGF) stabilized an alternative tetracysteine motif, consistent with a different intracellular JM structure. Evidence for ‘inside-out’ signaling
in EGFR has also been reported, where alterations in the intracellular JM region directly influence allosteric EGF binding to the ECR of the intact receptor analyzed in CHO cells [21–23]. The contradictory
views of flexibility versus rigidity  in linkages between the domains leave the path to understanding the intact receptor unclear, although it seems  reasonable doubt that  the inactive dimers known to
form in the absence of ligand [24–26] could be regulated by extracellular ligand if all linkages are always highly flexible.
Does the membrane hold the key?
All of the studies that support direct conformational communication between the extracellular and intracellular regions of EGFR were performed in cells [17,21,22]. By contrast, most of those that
explicitly suggest otherwise were performed in detergent micelles [13,14,15] — where the potentially important influences of specific membrane lipids (or membrane geometry) are absent. Studies of intact  EGFR in liposomes with defined lipid compositions [27] have shown that the ganglioside GM3 inhibits ligand-independent activation (and dimerization) of the receptor, apparently through interactions with a  site in its extracellular JM region. McLaughlin and colleagues [28,29] also proposed a model in which interaction of the intracellular JM region (and TKD) with anionic phospholipids in the inner leaflet of  the plasma membrane (notably PtdIns(4,5)P2) exerts an inhibitory effect that must be overcome in order for EGFR to signal. Association of the JM and TM regions with specific membrane lipids is likely to  define specific structures in the linkages between the EGFR extracellular and intracellular regions that are more well-defined (and potentially rigid) than is typically appreciated. Recent studies have begun to  shed some structural light on how membrane interactions with the intracellular JM region of EGFR might influence the signaling mechanism. Endres et al. [20] found that simply tethering the complete  intracellular region of EGFR to the inner leaflet of the plasma membrane maintains the TKD in a largely monomeric state and inhibits its kinase activity. Parallel computational studies [30] suggest that this  results from the previously proposed [29] inhibitory interaction of the JM and TKD regions of EGFR with the negatively charged membrane surface. The data of Endres et al. [20] further indicated that TM-mediated dimerization reverses this inhibitory effect. Moreover, NMR studies of a 60-residue peptide containing the TM and part of  the JM region solubilized in lipid bicelles led them to conclude that specific  TM dimerization through an N terminal GxxxG motif stabilizes formation of an antiparallel coiled-coil between the two JM fragments in the dimer — the same JM coiled-coil shown in Figure 2b/c that was  investigated in the bipartite tetracysteine display studies of  intact EGF-bound EGFR described above [17,19]. Independent solid-state NMR studies of a similar TM-JM peptide from the EGFR relative
ErbB2 in vesicles containing acidic phospholipids [31] further suggested that an activating mutation in the TM domain leads to release of  the JM region from the anionic membrane surface. Collectively,
these data suggest that ligand-induced dimerization of the receptor (or reorientation of receptors within a dimer) may engage the TM domain in a specific dimer that promotes both the formation of activating
interactions in the JM region and the disruption of inhibitory interactions between the JM region (and possibly TKD) and the membrane surface.

Negative cooperativity 
A key characteristic of ligand binding at the cell surface to EGFR [36], IR [37], and other receptors [38] is negative cooperativity — which is lost when soluble forms of the ECR from human EGFR [39]
or IR [40] are studied in isolation. Several studies have shown that intracellular and/or transmembrane regions are required for this negative cooperativity to be manifest [21,22,40,41], implying that
these parts of the receptor contribute to breaking the symmetry of the dimer — as required for the two sites to have distinct binding properties [42]. Such propagation of dimer asymmetry across the
membrane would surely require defined structures in the regions that connect extracellular and intracellular regions, and is difficult to reconcile with highly flexible JM linkers.
In brief, binding of one ligand stabilizes a singly-liganded asymmetric dimer in which the unoccupied ligand-binding site is compromised [43]. The binding affinity of the second ligand is thus reduced,
constituting a half-of-the-sites mode of negative cooperativity [44]. Leahy’s group has provided important evidence consistent with a similar mechanism in the cases of human EGFR and ErbB4 [16].
By comparing human ErbB receptor ECR dimer crystal structures with different bound ligands, Leahy and colleagues went on to identify two types of dimer interface [16], a ‘flush’ interface that resembles
the asymmetric (singly-liganded) dimer seen for the Drosophila EGFR [43] and a ‘staggered’ interface seen in the ECRs from EGFR (with bound EGF [12]) and ErbB4 (with bound neuregulin1b[16]).
These observations suggest that the ‘flush’ interface drives the most  stable dimers, which are singly liganded (Figure 2b). Binding of the second ligand is weaker, and also forces the dimer interface
into the less stable ‘staggered’ conformation (Figure 2c). Taken together, these findings suggest both a structural basis for negative cooperativity and a possible structural distinction between singly-liganded
and doubly-liganded ErbB receptor dimers.

A model for EGFR activation
The model shown in Figure 2 summarizes key proposed steps in the activation of human EGFR. In the absence of ligand, the ECR exists in a tethered conformation with the domain II ‘dimerization
arm’ engaged in an intramolecular interaction with domain IV that occludes the dimer interface [49]. The TKDs and the N-terminal portions of each intracellular JM region are thought to be engaged
in autoinhibitory interactions with the membrane surface [20,28,29,30].

Figure 2. More detailed view of EGF-induced activation of EGFR, as described in the text.
In the absence of ligand (a), the ECR adopts a tethered conformation, with an autoinhibitory tether interaction between domains II and IV. The TKD and JM regions lie against the membrane, making what
are believed to be additional autoinhibitory interactions. Domains I and III of the ECR are colored red, and domains II and IV are green. The JM helix is shown as a short cylinder and labeled in magenta.
The N-lobes and C-lobes of the kinase are also labeled, and both helix aC (blue) and the short helix in the activation loop (green) that interacts with aC to inhibit the TKD [50] are shown. The C-tail is
also depicted as a curve bearing 5 tyrosines. As described in the text, binding of a single ligand (b) induces formation of a singly-liganded dimer with a ‘flush’ (presumed asymmetric) ECR dimer interface.
The JM region forms an anti-parallel helix, as labeled in magenta, and the TKDs form an asymmetric dimer in which the activator (grey) allosterically activates the receiver (shown with an amber N-lobe).
It is not clear how the extracellular and intracellular asymmetry is structurally related, if at all. Finally, a second ligand binds to yield a more symmetric dimer with the ‘staggered’ ECR interface (c) described
in the text.

Conclusions Our mechanistic understanding of EGFR and its relatives has advanced dramatically in recent years, and the past year or two has seen substantial progress in putting the results of studies
with isolated domains together into initial views of how the intact receptor works. New insights into the origin of allosteric regulation of EGFR have been gained through a combination of innovative
structural, biochemical, cellular, and computational studies. A self-consistent picture is beginning to emerge. Two key issues remain unclear, however, and represent the current frontiers in studies of EGFR.
The first — for which we describe progress in this review — centers on the influence of specific interactions of the receptor with membrane lipids, which seem likely to define the structural ‘connections’
between extracellular and intracellular regions of the receptor. The second centers on the role of the carboxy-terminal 230 amino acids, which is believed to play a regulatory role for which little detail has
so far been defined [55].
(10PRE4140108).
DMF
is
supported
by

7.3.6 Complex Relationship between Ligand Binding and Dimerization in the Epidermal Growth Factor Receptor

Bessman NJ1Bagchi A2Ferguson KM2Lemmon MA3.
Cell Rep. 2014 Nov 20; 9(4):1306-17.
http://dx.doi.org/10.1016/j.celrep.2014.10.010

Highlights

  • Preformed extracellular dimers of human EGFR are structurally heterogeneous • EGFR dimerization does not stabilize ligand binding
    • Extracellular mutations found in glioblastoma do not stabilize EGFR dimerization • Glioblastoma mutations in EGFR increase ligand-binding affinity

The epidermal growth factor receptor (EGFR) plays pivotal roles in development and is mutated or overexpressed in several cancers. Despite recent advances, the complex allosteric regulation of EGFR remains incompletely understood. Through efforts to understand why the negative cooperativity observed for intact EGFR is lost in studies of its isolated extracellular region (ECR), we uncovered unexpected relationships between ligand binding and receptor dimerization. The two processes appear to compete. Surprisingly, dimerization does not enhance ligand binding (although ligand binding promotes dimerization). We further show that simply forcing EGFR ECRs into preformed dimers without ligand yields ill-defined, heterogeneous structures. Finally, we demonstrate that extracellular EGFR-activating mutations in glioblastoma enhance ligand-binding affinity without directly promoting EGFR dimerization, suggesting that these oncogenic mutations alter the allosteric linkage between dimerization and ligand binding. Our findings have important implications for understanding how EGFR and its relatives are activated by specific ligands and pathological mutations.

http://www.cell.com/cms/attachment/2020816777/2040986303/fx1.jpg

X-ray crystal structures from 2002 and 2003 (Burgess et al., 2003) yielded the scheme for ligand-induced epidermal growth factor receptor (EGFR) dimerization shown in Figure 1. Binding of a single ligand to domains I and III within the same extracellular region (ECR) stabilizes an “extended” conformation and exposes a dimerization interface in domain II, promoting self-association with a KD in the micromolar range (Burgess et al., 2003, Dawson et al., 2005, Dawson et al., 2007). Although this model satisfyingly explains ligand-induced EGFR dimerization, it fails to capture the complex ligand-binding characteristics seen for cell-surface EGFR, with concave-up Scatchard plots indicating either negative cooperativity (De Meyts, 2008, Macdonald and Pike, 2008) or distinct affinity classes of EGF-binding site with high-affinity sites responsible for EGFR signaling (Defize et al., 1989). This cooperativity or heterogeneity is lost when the ECR from EGFR is studied in isolation, as also described for the insulin receptor (De Meyts, 2008).

Figure 1

Structural View of Ligand-Induced Dimerization of the hEGFR ECR

(A) Surface representation of tethered, unliganded, sEGFR from Protein Data Bank entry 1NQL (Ferguson et al., 2003). Ligand-binding domains I and III are green and cysteine-rich domains II and IV are cyan. The intramolecular domain II/IV tether is circled in red.

(B) Hypothetical model for an extended EGF-bound sEGFR monomer based on SAXS studies of an EGF-bound dimerization-defective sEGFR variant (Dawson et al., 2007) from PDB entry 3NJP (Lu et al., 2012). EGF is blue, and the red boundary represents the primary dimerization interface.

(C) 2:2 (EGF/sEGFR) dimer, from PDB entry 3NJP (Lu et al., 2012), colored as in (B). Dimerization arm contacts are circled in red.

http://www.cell.com/cms/attachment/2020816777/2040986313/gr1.sml

Here, we describe studies of an artificially dimerized ECR from hEGFR that yield useful insight into the heterogeneous nature of preformed ECR dimers and into the origins of negative cooperativity. Our data also argue that extracellular structures induced by ligand binding are not “optimized” for dimerization and conversely that dimerization does not optimize the ligand-binding sites. We also analyzed the effects of oncogenic mutations found in glioblastoma patients (Lee et al., 2006), revealing that they affect allosteric linkage between ligand binding and dimerization rather than simply promoting EGFR dimerization. These studies have important implications for understanding extracellular activating mutations found in EGFR/ErbB family receptors in glioblastoma and other cancers and also for understanding specificity of ligand-induced ErbB receptor heterodimerization

Predimerizing the EGFR ECR Has Modest Effects on EGF Binding

To access preformed dimers of the hEGFR ECR (sEGFR) experimentally, we C-terminally fused (to residue 621 of the mature protein) either a dimerizing Fc domain (creating sEGFR-Fc) or the dimeric leucine zipper from S. cerevisiae GCN4 (creating sEGFR-Zip). Size exclusion chromatography (SEC) and/or sedimentation equilibrium analytical ultracentrifugation (AUC) confirmed that the resulting purified sEGFR fusion proteins are dimeric (Figure S1). To measure KD values for ligand binding to sEGFR-Fc and sEGFR-Zip, we labeled EGF with Alexa-488 and monitored binding in fluorescence anisotropy (FA) assays. As shown in Figure 2A, EGF binds approximately 10-fold more tightly to the dimeric sEGFR-Fc or sEGFR-Zip proteins than to monomeric sEGFR (Table 1). The curves obtained for EGF binding to sEGFR-Fc and sEGFR-Zip showed no signs of negative cooperativity, with sEGFR-Zip actually requiring a Hill coefficient (nH) greater than 1 for a good fit (nH = 1 for both sEGFRWT and sEGFR-Fc). Thus, our initial studies argued that simply dimerizing human sEGFR fails to restore the negatively cooperative ligand binding seen for the intact receptor in cells.

One surprise from these data was that forced sEGFR dimerization has only a modest (≤10-fold) effect on EGF-binding affinity. Under the conditions of the FA experiments, isolated sEGFR (without zipper or Fc fusion) remains monomeric; the FA assay contains just 60 nM EGF, so the maximum concentration of EGF-bound sEGFR is also limited to 60 nM, which is over 20-fold lower than the KD for dimerization of the EGF/sEGFR complex (Dawson et al., 2005, Lemmon et al., 1997). This ≤10-fold difference in affinity for dimeric and monomeric sEGFR seems small in light of the strict dependence of sEGFR dimerization on ligand binding (Dawson et al., 2005,Lax et al., 1991, Lemmon et al., 1997). Unliganded sEGFR does not dimerize detectably even at millimolar concentrations, whereas liganded sEGFR dimerizes with KD ∼1 μM, suggesting that ligand enhances dimerization by at least 104– to 106-fold. Straightforward linkage of dimerization and binding equilibria should stabilize EGF binding to dimeric sEGFR similarly (by 5.5–8.0 kcal/mol). The modest difference in EGF-binding affinity for dimeric and monomeric sEGFR is also significantly smaller than the 40- to 100-fold difference typically reported between high-affinity and low-affinity EGF binding on the cell surface when data are fit to two affinity classes of binding site (Burgess et al., 2003, Magun et al., 1980).

Mutations that Prevent sEGFR Dimerization Do Not Significantly Reduce Ligand-Binding Affinity

The fact that predimerizing sEGFR only modestly increased ligand-binding affinity led us to question the extent to which domain II-mediated sEGFR dimerization is linked to ligand binding. It is typically assumed that the domain II conformation stabilized upon forming the sEGFR dimer in Figure 1C optimizes the domain I and III positions for EGF binding. To test this hypothesis, we introduced a well-characterized pair of domain II mutations into sEGFRs that block dimerization: one at the tip of the dimerization arm (Y251A) and one at its “docking site” on the adjacent molecule in a dimer (R285S). The resulting (Y251A/R285S) mutation abolishes sEGFR dimerization and EGFR signaling (Dawson et al., 2005, Ogiso et al., 2002). Importantly, we chose isothermal titration calorimetry (ITC) for these studies, where all interacting components are free in solution. Previous surface plasmon resonance (SPR) studies have indicated that dimerization-defective sEGFR variants bind immobilized EGF with reduced affinity (Dawson et al., 2005), and we were concerned that this reflects avidity artifacts, where dimeric sEGFR binds more avidly than monomeric sEGFR to sensor chip-immobilized EGF.

Surprisingly, our ITC studies showed that the Y251A/R285S mutation has no significant effect on ligand-binding affinity for sEGFR in solution (Table 1). These experiments employed sEGFR (with no Fc fusion) at 10 μM—ten times higher than KD for dimerization of ligand-saturated WT sEGFR (sEGFRWT) (KD ∼1 μM). Dimerization of sEGFRWT should therefore be complete under these conditions, whereas the Y251A/R285S-mutated variant (sEGFRY251A/R285S) does not dimerize at all (Dawson et al., 2005). The KD value for EGF binding to dimeric sEGFRWT was essentially the same (within 2-fold) as that for sEGFRY251A/R285S (Figures 2B and 2C; Table 1), arguing that the favorable Gibbs free energy (ΔG) of liganded sEGFR dimerization (−5.5 to −8 kcal/mol) does not contribute significantly (<0.4 kcal/mol) to enhanced ligand binding. …

Thermodynamics of EGF Binding to sEGFR-Fc

If there is no discernible positive linkage between sEGFR dimerization and EGF binding, why do sEGFR-Fc and sEGFR-Zip bind EGF ∼10-fold more strongly than wild-type sEGFR? To investigate this, we used ITC to compare EGF binding to sEGFR-Fc and sEGFR-Zip (Figures 3A and 3B ) with binding to isolated (nonfusion) sEGFRWT. As shown in Table 1, the positive (unfavorable) ΔH for EGF binding is further elevated in predimerized sEGFR compared with sEGFRWT, suggesting that enforced dimerization may actually impair ligand/receptor interactions such as hydrogen bonds and salt bridges. The increased ΔH is more than compensated for, however, by a favorable increase in TΔS. This favorable entropic effect may reflect an “ordering” imposed on unliganded sEGFR when it is predimerized, such that it exhibits fewer degrees of freedom compared with monomeric sEGFR. In particular, since EGF binding does induce sEGFR dimerization, it is clear that predimerization will reduce the entropic cost of bringing two sEGFR molecules into a dimer upon ligand binding, possibly underlying this effect.

Possible Heterogeneity of Binding Sites in sEGFR-Fc

Close inspection of EGF/sEGFR-Fc titrations such as that in Figure 3A suggested some heterogeneity of sites, as evidenced by the slope in the early part of the experiment. To investigate this possibility further, we repeated titrations over a range of temperatures. We reasoned that if there are two different types of EGF-binding sites in an sEGFR-Fc dimer, they might have different values for heat capacity change (ΔCp), with differences that might become more evident at higher (or lower) temperatures. Indeed, ΔCp values correlate with the nonpolar surface area buried upon binding (Livingstone et al., 1991), and we know that this differs for the two Spitz-binding sites in the asymmetric Drosophila EGFR dimer (Alvarado et al., 2010). As shown in Figure 3C, the heterogeneity was indeed clearer at higher temperatures for sEGFR-Fc—especially at 25°C and 30°C—suggesting the possible presence of distinct classes of binding sites in the sEGFR-Fc dimer. We were not able to fit the two KD values (or ΔH values) uniquely with any precision because the experiment has insufficient information for unique fitting to a model with four variables. Whereas binding to sEGFRWT could be fit confidently with a single-site binding model throughout the temperature range, enforced sEGFR dimerization (by Fc fusion) creates apparent heterogeneity in binding sites, which may reflect negative cooperativity of the sort seen with dEGFR. …

Ligand Binding Is Required for Well-Defined Dimerization of the EGFR ECR

To investigate the structural nature of the preformed sEGFR-Fc dimer, we used negative stain electron microscopy (EM). We hypothesized that enforced dimerization might cause the unliganded ECR to form the same type of loose domain II-mediated dimer seen in crystals of unliganded Drosophila sEGFR (Alvarado et al., 2009). When bound to ligand (Figure 4A), the Fc-fused ECR clearly formed the characteristic heart-shape dimer seen by crystallography and EM (Lu et al., 2010, Mi et al., 2011). Figure 4B presents a structural model of an Fc-fused liganded sEGFR dimer, and Figure 4C shows a calculated 12 Å resolution projection of this model. The class averages for sEGFR-Fc plus EGF (Figure 4A) closely resemble this model, yielding clear densities for all four receptor domains, arranged as expected for the EGF-induced domain II-mediated back-to-back extracellular dimer shown in Figure 1 (Garrett et al., 2002, Lu et al., 2010). In a subset of classes, the Fc domain also appeared well resolved, indicating that these particular arrangements of the Fc domain relative to the ECR represent highly populated states, with the Fc domains occupying similar positions to those of the kinase domain in detergent-solubilized intact receptors (Mi et al., 2011). …

Our results and those of Lu et al. (2012)) argue that preformed extracellular dimers of hEGFR do not contain a well-defined domain II-mediated interface. Rather, the ECRs in these dimers likely sample a broad range of positions (and possibly conformations). This conclusion argues against recent suggestions that stable unliganded extracellular dimers “disfavor activation in preformed dimers by assuming conformations inconsistent with” productive dimerization of the rest of the receptor (Arkhipov et al., 2013). The ligand-free inactive dimeric ECR species modeled by Arkhipov et al. (2013) in their computational studies of the intact receptor do not appear to be stable. The isolated ECR from EGFR has a very low propensity for self-association without ligand, with KD in the millimolar range (or higher). Moreover, sEGFR does not form a defined structure even when forced to dimerize by Fc fusion. It is therefore difficult to envision how it might assume any particular autoinhibitory dimeric conformation in preformed dimers. …

Extracellular Oncogenic Mutations Observed in Glioblastoma May Alter Linkage between Ligand Binding and sEGFR Dimerization

Missense mutations in the hEGFR ECR were discovered in several human glioblastoma multiforme samples or cell lines and occur in 10%–15% of glioblastoma cases (Brennan et al., 2013, Lee et al., 2006). Several elevate basal receptor phosphorylation and cause EGFR to transform NIH 3T3 cells in the absence of EGF (Lee et al., 2006). Thus, these are constitutively activating oncogenic mutations, although the mutated receptors can be activated further by ligand (Lee et al., 2006, Vivanco et al., 2012). Two of the most commonly mutated sites in glioblastoma, R84 and A265 (R108 and A289 in pro-EGFR), are in domains I and II of the ECR, respectively, and contribute directly in inactive sEGFR to intramolecular interactions between these domains that are thought to be autoinhibitory (Figure 5). Domains I and II become separated from one another in this region upon ligand binding to EGFR (Alvarado et al., 2009), as illustrated in the lower part of Figure 5. Interestingly, analogous mutations in the EGFR relative ErbB3 were also found in colon and gastric cancers (Jaiswal et al., 2013).

We hypothesized that domain I/II interface mutations might activate EGFR by disrupting autoinhibitory interactions between these two domains, possibly promoting a domain II conformation that drives dimerization even in the absence of ligand. In contrast, however, sedimentation equilibrium AUC showed that sEGFR variants harboring R84K, A265D, or A265V mutations all remained completely monomeric in the absence of ligand (Figure 6A) at a concentration of 10 μM, which is similar to that experienced at the cell surface (Lemmon et al., 1997). As with WT sEGFR, however, addition of ligand promoted dimerization of each mutated sEGFR variant, with KD values that were indistinguishable from those of WT. Thus, extracellular EGFR mutations seen in glioblastoma do not simply promote ligand-independent ECR dimerization, consistent with our finding that even dimerized sEGFR-Fc requires ligand binding in order to form the characteristic heart-shaped dimer. …

We suggest that domain I is normally restrained by domain I/II interactions so that its orientation with respect to the ligand is compromised. When the domain I/II interface is weakened with mutations, this effect is mitigated. If this results simply in increased ligand-binding affinity of the monomeric receptor, the biological consequence might be to sensitize cells to lower concentrations of EGF or TGF-α (or other agonists). However, cellular studies of EGFR with glioblastoma-derived mutations (Lee et al., 2006, Vivanco et al., 2012) clearly show ligand-independent activation, arguing that this is not the key mechanism. The domain I/II interface mutations may also reduce restraints on domain II so as to permit dimerization of a small proportion of intact receptor, driven by the documented interactions that promote self-association of the transmembrane, juxtamembrane, and intracellular regions of EGFR (Endres et al., 2013, Lemmon et al., 2014, Red Brewer et al., 2009).

Setting out to test the hypothesis that simply dimerizing the EGFR ECR is sufficient to recover the negative cooperativity lost when it is removed from the intact receptor, we were led to revisit several central assumptions about this receptor. Our findings suggest three main conclusions. First, we find that enforcing dimerization of the hEGFR ECR does not drive formation of a well-defined domain II-mediated dimer that resembles ligand-bound ECRs or the unliganded ECR from Drosophila EGFR. Our EM and SAXS data show that ligand binding is necessary for formation of well-defined heart-shaped domain II-mediated dimers. This result argues that the unliganded extracellular dimers modeled by Arkhipov et al. (2013)) are not stable and that it is improbable that stable conformations of preformed extracellular dimers disfavor receptor activation by assuming conformations that counter activating dimerization of the rest of the receptor. Recent work from the Springer laboratory employing kinase inhibitors to drive dimerization of hEGFR (Lu et al., 2012) also showed that EGF binding is required to form heart-shaped ECR dimers. These findings leave open the question of the nature of the ECR in preformed EGFR dimers but certainly argue that it is unlikely to resemble the crystallographic dimer seen for unligandedDrosophila EGFR (Alvarado et al., 2009) or that suggested by computational studies (Arkhipov et al., 2013).

This result argues that ligand binding is required to permit dimerization but that domain II-mediated dimerization may compromise, rather than enhance, ligand binding. Assuming flexibility in domain II, we suggest that this domain serves to link dimerization and ligand binding allosterically. Optimal ligand binding may stabilize one conformation of domain II in the scheme shown in Figure 1 that is then distorted upon dimerization of the ECR, in turn reducing the strength of interactions with the ligand. Such a mechanism would give the appearance of a lack of positive linkage between ligand binding and ECR dimerization, and a good test of this model would be to determine the high-resolution structure of a liganded sEGFR monomer (which we expect to differ from a half dimer). This model also suggests a mechanism for selective heterodimerization over homodimerization of certain ErbB receptors. If a ligand-bound EGFR monomer has a domain II conformation that heterodimerizes with ErbB2 in preference to forming EGFR homodimers, this could explain several important observations. It could explain reports that ErbB2 is a preferred heterodimerization partner of EGFR (Graus-Porta et al., 1997) and might also explain why EGF binds more tightly to EGFR in cells where it can form heterodimers with ErbB2 than in cells lacking ErbB2, where only EGFR homodimers can form (Li et al., 2012).

7.3.7 IGFBP-2/PTEN: A critical interaction for tumours and for general physiology?

IGFBP-2
The insulin-like growth factor family of proteins, together with insulin, form an evolutionarily conserved system that helps to coordinate the metabolic status and activity of organisms with their nutritional environment. When food is abundant, the IGF/insulin signalling pathway is switched on and cell proliferation and other activities are enhanced; while when food is limited, such activities are suppressed to conserve energy and resources [1,2]. The IGF axis consists of two ligands IGF-I and -II, a series of heterotetrameric tyrosine kinase receptors and six high affinity binding proteins IGFBP-1 to-6. These IGFBPs not only regulate the reservoir, availability and functions of IGFs but also have direct actions upon cell behaviour that are independent of IGF-binding [3]. The six IGFBPs are conserved in all placental mammals having evolved from serial duplication of genes that were present throughout vertebrate evolution [4]. Each of the six IGFBPs has evolved unique functions that presumably have conferred some evolutionary advantage and hence have been conserved across mammalian evolution. After IGFBP-3, IGFBP-2 is the second most abundant binding protein in the circulation throughout adult life in humans. While circulating IGFBP-3 levels peak during puberty and decrease thereafter, IGFBP-2 levels are highest in infancy and old age. Together with the other five IGFBPs, IGFBP-2 regulates IGF availability and actions and has pleiotropic effects on normal and neoplastic tissues [3]. One of the clear distinctive structural features of IGFBP-2 is that it contains an Arg-Gly-Asp (RGD) sequence that enables functional interactions with integrin receptors [4]. This structural element is only present in one of the other IGFBPs, IGFBP-1. Although the RGD sequence was only acquired in IGFBP-1 during mammalian evolution it was present within IGFBP-2 from early vertebrate evolution indicating that it has been a long retained functional characteristic of IGFBP-2 [4]. The integrin receptors are critical for the anchorage of cells to the extracellular matrix (ECM) within tissues and hence for maintaining tissue architecture [5,6]. In solid tissue an important safeguard is imposed by linking normal cell functions and proliferation to appropriate cues from the ECM that are mediated by signals from attachment receptors such as the integrin receptors. Anchoragedependent growth is a common feature of normal cells and loss of attachment results in a form of apoptosis called anoikis. The integrin receptors interact with growth factor receptors in an ancillary and permissive manner to ensure that the signals for growth and survival occur in the appropriate setting and not inappropriately in detached cells. It has also become clear that integrin receptors serve many other roles in regulating cell functions and integrating cues from the surrounding ECM [5,6]. Over the last few decades, as the role of IGFBPs as extracellular modulators of IGF-availability and actions has emerged, there has also been a gradual characterization of the intracellular counter-regulatory components that modulate the signals initiated by IGF-receptor activation. There has been considerable progress in charting the signalling cascades initiated from these receptors but it is evident that the reason needs to be mechanisms for inactivating the pathways in intervening periods in preparation for subsequent activation. Throughout the canonical kinase cascades, activated by receptor ligation, at each node there is a corresponding phosphatase that returns the pathway to the inactive state and modulates the signal. The extracellular regulators of these phosphatases have however received much less attention than the activating kinases. That the extracellular counter-regulators may act in synchrony and be linked to the intracellular counter-regulators has only recently started to be revealed. Transgenic over-expression of IGFBP-2 at supra-physiological levels in mice results in reduced somatic growth [7] and this growth deficit is more pronounced when these mice were crossed with mice with raised growth hormone/IGF-I [8] implying that the growth inhibitory effect was due to sequestration of IGF-I. As with most of the IGFBP-family [3], there are also however multiple lines of evidence that IGFBP-2 has cellular actions that are independent of its ability to bind IGFs. There is evidence that IGFBP-2 initiates intrinsic cellular signalling through specific binding of its RGD-motif to integrin receptors, particularly the α5β1 integrin.In addition IGFBP-2 appears to modulate IGF and epidermal growth factor signalling through interactions with α5β3 integrins [9]. A heparin binding domain also exists in IGFBP-2 and it has been shown to bind to glycosaminoglycans [10], heparin [11], and other proteoglycans such as the receptor protein tyrosine phosphatase-β (RPTPβ) [12,13]. In addition,IGFBP-2has been reported to be localized on the cell surface, in the cytoplasm and on the nuclear membrane[14]. Several groups have now reported nuclear localization of IGFBP-2 [15–17]. A functional nuclear localization sequence in the central domain of IGFBP-2 has been reported that appears to interact with importin-α [18]. In the nucleus IGFBP-2 has been reported to regulate the expression of vascular endothelial growth factor [19].
IGFBP-2 and metabolic regulation
Epidemiological studies of human populations have indicated that IGFBP-2 levels are reduced in obesity, metabolic syndrome and type 2 diabetes and are inversely correlated with insulin sensitivity [20]. That these associations were due to a metabolic role for IGFBP-2, rather thanitjustbeingamarkerofdisturbance,hasbeenconfirmedinanumber of animal models. Using a transgenic IGFBP-2 over-expressing mouse model, Wheatcroft and coworkers found that IGFBP-2 was able to protect mice from high-fat/high-energy induced obesity and insulin resistance, and also protected the mice from the age-related development of glucose intolerance and hypertension [21]. Over-expression of IGFBP-2 induced by Leptin in wild type or obese mice similarly resulted in reduced plasma glucose and insulin levels [22]. All these data indicate a metabolic role for IGFBP-2 in glucose homeostasis.
IGFBP-2 and cancer
As indicated above, the early reports had implied that IGFBP-2 was generally a negative regulator of IGF-activity; the systemic growth restriction observed in transgenic mice over-expressing IGFBP-2 was followed by observations that chemically induced colorectal cancers were inhibited in this model [23]. Despite this there has been an accumulation of evidence indicating that IGFBP-2 is positively associated with the malignant progression of a wide range of cancers, as has been reviewed previously [24]. Raised serum levels of IGFBP-2 have been reported and positive associations between tumor IGFBP-2 expression and malignancy or metastasis have been observed for a variety of cancers, including glioma [25], breast [26], prostate [27], lung [28], colon [29] and lymphoid tumor [30]. Subsequent work has generally been consistent with this association between IGFBP-2 and cancer progression. In view of the majority of evidence, indicating that IGFBP-2 interacting with IGFs generally inhibited cell growth, it was suggested thatIGF-independentactionswereprobablyresponsibleforpositiveassociations between IGFBP-2 and tumourgrowth and progression [24]. The explanation for the increased expression of IGFBP-2 that has beenreportedformanydifferentcancersappearstocomefromthefactorsthat have been shown to regulate IGFBP-2 expression.The tumor suppressor gene p53, which is the most mutated gene in many human cancers, has been reported to transcriptionally regulate IGFBP-2 [31].

There also appears to again be reciprocal feedback as p53 mRNA in the breast cancer cell line Hs578T increased significantly after treatment with human recombinant IGFBP-2, suggesting a close interaction between IGFBP-2 and p53 [14]. A number of hormonal regulators of IGFBP-2 expression have been described including hCG, FSH, TGF-β, IL1, estradiol, glucocorticoids, EGF, IGF-I, IGF-II and insulin [24]. The stimulation of IGFBP-2 expression by EGF, IGF-I, IGF-II and insulin has been shown to be via the PI3K/AKT/mTOR pathway in breast cancer cells [32] and in adipocytes [33]. This is one of the most well characterisedsignallingpathwaysactivatedbyinsulinandIGFs.Inaddition the critical counter-regulatory phosphatase that deactivates this pathway the phosphatase and tensin homologue PTEN has been shown to downregulate the expression of IGFBP-2 [34]. This suggests another autoregulatory loop in which activation of the PI3K/AKT/mTOR pathway by IGFs induces the expression of IGFBP-2 that then sequesters the IGFs and modulates the signal. As activating mutations in the PI3K pathway or loss of PTEN are very common across a variety of human cancers, this plus the effect of p53, probably accounts for the common dysregulation of IGFBP-2 observed across many cancers. Using prostate cancer cell lines it has also been shown that local IGFBP-2 expression is metabolically regulated; IGFBP-2 expression was increased in hyperglycemic conditions through acetylation of histones H3 and H4 associated with the IGFBP-2 promoter, furthermore this up-regulation of IGFBP-2 mediated hyperglycemia-induced chemo-resistance [35].

PI3K
The signaling kinase PI3K plays a fundamental role that has been maintained throughout most of evolution. The ability to control growth and development according to the availability of nutrients provides a survival advantage and therefore has been selectively retained throughout evolution. Evidence has accumulated to indicate that the PI3K pathway provides this control in all species from yeast to mammals.Various forms of the PI3K enzyme exist that are classified into three groups (classes I, II, and III). Only one of these forms is present in yeast and is equivalent to mammalian class III PI3K: this acts as a nutrient sensor and is directly activated by the availability of amino acids and then itself activates mTOR/S6K1 to regulate cell growth and development [36]. In mammals class 1API3K has evolved: this form is not directly activated by nutrients but consists of heterodimers comprising a catalytic p110 subunit and a regulatory p85 subunit that enables the enzyme to be controlled by receptor tyrosine kinases, classically the insulin and insulin-like growth factor receptors (IR and IGF-IR) [37]. This enables the regulation of PI3K by social nutritionally dependent signals rather than by nutrients directly. It is not by chance that the insulin/IGF/PI3K pathway plays a fundamental role in regulating both metabolism and growth as it clearly is an advantage to synchronize the set processes and this synchronized control has been maintained throughout evolution.

Phosphatase and tensin homolog (PTEN)
Of all the intracellular counter-regulators of the IGF-pathway the one that has received the most attention in relation to cancer is PTEN. PTEN is a lipid tyrosine phosphatase that negatively regulates the Akt/ PKB signaling pathway by specifically dephosphorylating phosphatidylinositol (3,4,5)-trisphosphate and thereby reduces AKT activation to reduce signals for cell metabolism, proliferation and survival [37]. PTEN is the second most often mutated tumor suppressor in human cancers, after p53[38]. Aberrant PTEN activity occurs due to mutation, homozygous deletion, loss of heterozygosity, or epigenetic silencing. Lost or reduced activity of PTEN has been observed in a great variety of cancers, including breast [39], prostate [40,41], colorectal [42], lung[43], glioblastoma [44], endometrial [45], etc. It has been demonstrated that deregulation of PTEN is involved in tumorigenesis, tumor progression and also the predisposition of many cancers [46]. AsPI3K/Akt signaling is critical for the metabolic effects of insulin. It is clear that PTEN will also play a role in modulating the metabolic actions of insulin. Consistent with this mice genetically modified to have haploinsufficiency of PTEN were observed to be hypersensitive to insulin [47]. Similarly humans with haplo-insufficiency due to mutations in PTEN were found to have enhanced insulin sensitivity [48]. Recently an increase in insulin sensitivity due to suppression of PTEN has been described in grizzly bears in preparation for hibernation, indicating that this is a mechanism for physiological adaptation [49]. Although the genetic defects resulting in PTEN loss in cancers and the intrinsic mechanisms for regulation of PTEN have been well characterised; there have been relatively few reports of external cell regulators. Of interest one of the few extrinsic regulators that has been described is IGF-II [50]. IGF-II is the most abundant growth factor present in most human tissues and activates the PI3K/AKT/mTOR pathway. Just as the induction of IGFBP-2 by activation of the PI3K pathway suggests an autoregulatory feedback loop extrinsic to the cell;the induction of PTEN by IGF-II via PI3K suggests an additional feedback loop that is intrinsic within the cell (Fig. 1). Activation of the pathway by IGF-II induces expression of PTEN that then attenuates the signal; conversely when the pathway is not activated then PTEN expression is reduced making the cell more responsive for when an activation signal is next received.One of the mechanisms that has emerged,to explain this feedback loop, indicates that the signaling output of the PI3K/PTEN pathway is balanced by asynchronous regulation of the activity of both PI3K and PTEN. The p85α regulatory subunit of PI3K that binds to and represses the activity of the p110 catalytic subunit also binds directly to PTEN at a regulatory site within PTEN where serine/threonine phosphorylation occurs to inactivatePTEN.The p85α subunit binds to unphosphorylated PTEN at this site and enhances its lipid phosphatase activity 3-fold [51]. The nature of this feedback loop has been further extended by reports that PTEN can suppress the expression of IGF-II [52,53]. As IGF-II induces PTEN, the ability of PTEN to subsequently reduce IGF-II expression may enable the cell to protect itself from over-stimulation. In contrast loss of PTEN may increase the expression of IGF-II resulting inactivation of the PI3K/AKT/mTOR pathway that is then unopposed.

PTEN/IGFBP-2 interactions
In view of the recognized importance of loss of PTEN for a variety of cancers there has been considerable interest in identifying biomarkers that could be used clinically to indicate loss of PTEN within tumors. An unbiased screen of human prostate cancer xenografts and human glioblastoma samples using microarray-based expression profiling found that the most significant gene was IGFBP-2 and it was confirmed in experimental models that IGFBP-2 was inversely regulated by PTEN [54]. This was consistent with all of the subsequent studies indicating that the expression of IGFBP-2 was regulated by the PI3K/AKT/mTOR pathway. An increase in tumor IGFBP-2 has also been associated with loss of PTEN in human breast cancer samples[55]. In the same year that a screen revealed IGFBP-2 as the best marker for loss of PTEN; the nature of the interaction between these two proteins was extended by the demonstration that at the cellular level IGFBP-2 can inversely regulate PTEN. With human breast cancer cells it was confirmed that IGF-II stimulated PTEN expression and that this was modulated by the binding of IGF-II to IGFBP-2, but when IGFBP-2 was not bound to IGF-II it was able to suppress PTEN via an interaction with cell surface integrin receptors (Fig. 1) [56]. Subsequent work with human prostate cancer cells indicated that the interaction of IGFBP-2 with integrin receptors could also result in PTEN inactivation via increasing its phosphorylation [57].

Fig.1. A proposed autoregulatory feedback loop of IGFBP-2/PTEN interaction. Binding of IGF-II to the IGF-IR activates the PI3K pathway. Induction of PI3K activates Akt and mTOR signaling and leads to cell proliferation and cell survival. The regulatory subunit of PI3K,p85, also binds and activates PTEN through dephosphorylation. This increased PTEN subsequently blocks IGFII production to avoid overstimulation. On the other hand, activated PI3K pathway induces IGFBP-2 expression, which when unbound to IGF-II, suppresses PTEN via an interaction with integrin receptors and/or the receptor protein tyrosine phosphatase β(RPTPβ). Thus the negative control of PTEN on PI3K signaling is counteracted. These feedback loops enable the extrinsic balance between IGF-II and IGFBP-2 to be tightly integrated to the intrinsic balance between PI3K and PTEN.

The ability of IGFBP-2 to regulate PTEN, originally observed in human cancer cell lines has subsequently been confirmed in a variety of normal cell types from different tissues. In IGFBP-2 knock-out mice a decrease in hematopoietic stem cell survival and cycling has been associated with an increase in PTEN and this appeared to be mediated by the heparin binding domain (HBD) within IGFBP-2 as the administration of a peptide analogue could restore the deficit [58]. Similarly a decrease in bone mass in the IGFBP-2 knock-out mice has been attributed to an increase in PTEN and again the use of a peptide analogue appeared to implicate the IGFBP-2HBD [59]. It was subsequently reported that the IGFBP-2HBD mediated an interaction with the RPTPβ resulting in dimerization and consequent inactivation of RPTPβ and that this reduction in phosphatase activity cooperated with IGF-I activation of the IGF-IR to enhance the phosphorylation and inactivation of PTEN [12]. Recently IGFBP-2 has been reported to also suppress PTEN in human skeletal muscle cells [60] and human visceral adipocytes [61] by interacting with integrin receptors. A similar association between IGFBP-2 and PTEN has been implicated as playing a role in murine skeletal muscle cell differentiation, although the functional regulation was not directly investigated in that study [62].

Summary
Evidence from a variety of different sources have indicated a close regulatory feedback loop between IGFBP-2 and PTEN. Work using a variety of different cell types from different tissues and different species has indicated that IGFBP-2 inversely regulates PTEN. There are reports that this is mediated via the IGFBP-2 RGD domain interacting with integrin receptors and by the IGFBP-2 HBD interacting with proteoglycans; the relative involvement of each of these domains and their functional interactions will require further work to elucidate. These studies however suggest a general mechanism that plays a role in a variety of normal physiological processes in addition to having important implications for the progression of many different cancers. The phosphatase PTEN has an important role in determining insulin sensitivity and the extent that IGFBP-2 exerts a metabolic role in regulating PTEN to determine insulin-sensitivity is yet to be examined. The extracellular balance between IGF-II and IGFBP-2 seems tightly linked with the intracellular balance between PI3K and PTEN (Fig. 1). When driving, in order to move forward there is a synchronous application of the accelerator and a removal of the brake. It appears that the cell also synchronizes activation of an essential regulatory pathway with the removal of the tightly linked inactivation pathway.

References
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[9] G.K.Wang,etal., Aninteraction betweeninsulin-likegrowthfactor-bindingprotein 2 (IGFBP2) and integrin alpha5 is essential for IGFBP2-induced cell mobility, J. Biol. Chem. 281 (20) (2006) 14085–14091. [10] T.Arai,W.BusbyJr.,D.R.Clemmons,Bindingofinsulin-likegrowthfactor(IGF)IorII to IGF-binding protein-2 enables it to bind to heparin and extracellular matrix, Endocrinology 137 (11) (1996) 4571–4575. [11] J. Lund, et al., Heparin-binding mechanism of the IGF2/IGF-binding protein 2 complex, J. Mol. Endocrinol. 52 (3) (2014) 345–355.
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7.3.8 Emerging roles for the pH-sensing G protein-coupled receptors in response to acidotic stress

Edward J Sanderlin, Calvin R Justus, Elizabeth A Krewson, Li V Yang
Cell Health & Cytoskel Mar 2015; 2015(7): 99—109
http://www.dovepress.com/emerging-roles-for-the-ph-sensing-g-protein-coupled-receptors-in-respo-peer-reviewed-article-CHC#

Protons (hydrogen ions) are the simplest form of ions universally produced by cellular metabolism including aerobic respiration and glycolysis. Export of protons out of cells by a number of acid transporters is essential to maintain a stable intracellular pH that is critical for normal cell function. Acid products in the tissue interstitium are removed by blood perfusion and excreted from the body through the respiratory and renal systems. However, the pH homeostasis in tissues is frequently disrupted in many pathophysiologic conditions such as in ischemic tissues and tumors where protons are overproduced and blood perfusion is compromised. Consequently, accumulation of protons causes acidosis in the affected tissue. Although acidosis has profound effects on cell function and disease progression, little is known about the molecular mechanisms by which cells sense and respond to acidotic stress. Recently a family of pH-sensing G protein-coupled receptors (GPCRs), including GPR4, GPR65 (TDAG8), and GPR68 (OGR1), has been identified and characterized. These GPCRs can be activated by extracellular acidic pH through the protonation of histidine residues of the receptors. Upon activation by acidosis the pH-sensing GPCRs can transduce several downstream G protein pathways such as the Gs, Gq/11, and G12/13 pathways to regulate cell behavior. Studies have revealed the biological roles of the pH-sensing GPCRs in the immune, cardiovascular, respiratory, renal, skeletal, endocrine, and nervous systems, as well as the involvement of these receptors in a variety of pathological conditions such as cancer, inflammation, pain, and cardiovascular disease. As GPCRs are important drug targets, small molecule modulators of the pH-sensing GPCRs are being developed and evaluated for potential therapeutic applications in disease treatment.

Cellular metabolism produces acid as a byproduct. Metabolism of each glucose molecule by glycolysis generates two pyruvate molecules. Under anaerobic conditions the metabolism of pyruvate results in the production of the glycolytic end product lactic acid, which has a pKa of 3.9. Lactic acid is deprotonated at the carboxyl group and results in one lactate ion and one proton at the physiological pH. Under aerobic conditions pyruvate is converted into acetyl-CoA and CO2 in the mitochondria. CO2in water forms a chemical equilibrium of carbonic acid and bicarbonate, an important physiological pH buffering system. The body must maintain suitable pH for proper physiological functions. Some regulatory mechanisms to control systemic pH are respiration, renal excretion, bone buffering, and metabolism.14 The respiratory system can buffer the blood by excreting carbonic acid as CO2 while the kidney responds to decreased circulatory pH by excreting protons and electrolytes to stabilize the physiological pH. Bone buffering helps maintain systemic pH by Ca2+ reabsorption and mineral dissolution. Collectively, it is clear that several biological systems require tight regulation to maintain pH for normal physiological functions. Cells utilize vast varieties of acid-base transporters for proper pH homeostasis within each biological context.58 Some such transporters are H+-ATPase, Na+/H+exchanger, Na+-dependent HCO3/C1 exchanger, Na+-independent anion exchanger, and monocarboxylate transporters. Cells can also maintain short-term pH homeostasis of the intracellular pH by rapid H+ consuming mechanisms. Some such mechanisms utilize metabolic conversions that move acids from the cytosol into organelles. Despite these cellular mechanisms that tightly maintain proper pH homeostasis, there are many diseases whereby pH homeostasis is disrupted. These pathological conditions are characterized by either local or systemic acidosis. Systemic acidosis can occur from respiratory, renal, and metabolic diseases and septic shock.14,9 Additionally, local acidosis is characterized in ischemic tissues, tumors, and chronically inflamed conditions such as in asthma and arthritis caused by deregulated metabolism and hypoxia.1015

Acidosis is a stress for the cell. The ability of the cell to sense and modulate activity for adaptation to the stressful environment is critical. There are several mechanisms whereby cells sense acidosis and modulate cellular functions to facilitate adaptation. Cells can detect extracellular pH changes by acid sensing ion channels (ASICs) and transient receptor potential (TRP) channels.16 Apart from ASIC and TRP channels, extracellular acidic pH was shown to stimulate inositol polyphosphate formation and calcium efflux.17,18 This suggested the presence of an unknown cell surface receptor that may be activated by a certain functional group, namely the imidazole of a histidine residue. The identity of the acid-activated receptor was later unmasked by Ludwig et al as a family of proton-sensing G protein-coupled receptors (GPCRs). This group identified human ovarian cancer GPCR 1 (OGR1) which upon activation will produce inositol phosphate and calcium efflux through the Gq pathway.19 These pH-sensing GPCR family members, including GPR4, GPR65 (TDAG8), and GPR68 (OGR1), will be discussed in this review (Figure 1). The proton-sensing GPCRs sense extracellular pH by protonation of several histidine residues on their extracellular domain. The activation of these proton-sensing GPCRs facilitates the downstream signaling through the Gq/11, Gs, and G12/13 pathways. Their expression varies in different cell types and play critical roles in sensing extracellular acidity and modulating cellular functions in several biological systems.

Figure 1 Biological roles and G protein coupling of the pH-sensing GPCRs.
Abbreviation: GPCRs, G protein-coupled receptors.

Role for the pH-sensing GPCRs in the immune system and inflammation

Acidic pH is a main characteristic of the inflammatory loci.14,20,21 The acidic microenvironment in inflamed tissue is predominately due to the increased metabolic demand from infiltrating immune cells, such as the neutrophil. These immune cells increase oxygen consumption and glucose uptake for glycolysis and oxidative phosphorylation. When oxygen availability is limited, cells often undergo anaerobic glycolysis. This process generates increasing amounts of lactic acid, thereby creating a local acidic microenvironment within the inflammatory loci.22 This presents a role for the pH-sensing GPCR GPR65 (TDAG8) in inflammation and immune cell function.23 TDAG8 was originally identified by cloning as an orphan GPCR which was observed to be upregulated during thymocyte apoptosis.24,25GPR65 (TDAG8) is predominately expressed in lymphoid tissues such as the spleen, lymph nodes, thymus, and leukocytes.2426 It was demonstrated that GPR65 inhibited pro-inflammatory cytokine secretion, which includes IL-6 and TNF-α, in mouse peritoneal macrophages upon activation by extracellular acidification. This cytokine inhibition was shown to occur through the Gs-cAMP-protein kinase A (PKA) signaling pathway.23,27 Treatment with dexamethasone, a potent glucocorticoid, increased GPR65 expression in peritoneal macrophages. Following dexamethasone treatment, there was an inhibition of TNF-α secretion in a manner dependent on increased expression of GPR65.28Another report provides an anti-inflammatory role for GPR65 in arthritis.29 Type II collagen-induced arthritis was increased in GPR65-null mice in comparison to wild-type mice. These studies taken together suggest GPR65 serves as a negative regulator in inflammation.30 However, one study provided a function for GPR65 as a positive modulator in inflammation.31 GPR65 was reported to increase eosinophil viability in the acidic microenvironment by reducing apoptosis through the cAMP pathway. As eosinophils are central in asthmatic inflammation and allergic airway disease, GPR65 may play a role in increasing asthmatic inflammation.31 On the other hand, GPR65 has shown little involvement in immune cell development. One report indicates that GPR65 knockout mice had normal immune development and function.26 Modulation of inflammation by GPR65 is complex and must be examined within each specific pathology.23

In addition to GPR65, GPR4 is also involved in the inflammatory response. Endothelial cells compose blood vessels that often penetrate acidic tissue microenvironments such as the inflammatory loci. Among the pH-sensing GPCR family, GPR4 has the highest expression in endothelial cells. Response to inflammation by vascular endothelial cells facilitates the induction of inflammatory cytokines that are involved in the recruitment of leukocytes for adherence and transmigration into inflamed tissues. Activation of GPR4 by acidosis in human umbilical vein endothelial cells, among other endothelial cell types, increased the expression of a broad range of pro-inflammatory genes including chemokines, cytokines, PTGS2, NF-κB pathway genes, and adhesion molecules.32 Moreover, human umbilical vein endothelial cells, when treated with acidic pH, increased GPR4-mediated endothelial adhesion to leukocytes.32,33 Altogether, GPR65 and GPR4 provide differential regulation of the inflammatory response through their acid sensing capabilities. GPR65 predominately demonstrates function in the inhibition of the inflammatory response whereas GPR4 activation exacerbates inflammation.

Role for the pH-sensing GPCRs in the cardiovascular system

Taken together, both GPR4 and GPR68 play roles in regulating the function of the cardiovascular system. GPR4 regulates blood vessel stability and endothelial cell function and GPR68 increases cardiomyogenic and pro-survival gene expression while also mediating aortic smooth muscle cell gene expression.

Role for the pH-sensing GPCRs in the renal system

GPR4 is expressed in the kidney cortex, isolated kidney collecting ducts, inner and outer medulla, and in cultured inner and outer medullary collecting duct cells.59 In mice deficient for GPR4, renal acid excretion and the ability to respond to metabolic acidosis was reduced.59 In response to acidosis, inner and outer medullary collecting duct cells produced cAMP, a second messenger for the Gs G-protein pathway, through the GPR4 receptor.59 In renal HEK293 epithelial cells GPR4 overexpression was found to increase the activity of PKA.60 In addition, the protein expression of H+-K+-ATPase α-subunit (HKα2) was increased following GPR4 overexpression dependent on increased PKA activity.60

GPR68 has also been reported to alter proton export of HEK293 cells by stimulating the Na+/H+exchanger and H+-ATPase.58 The activation of GPR68 by acidosis was found to stimulate this effect through a cluster of extracellular histidine residues and the Gq/PKC signaling pathway.58 In GPR68-null mice the expression of the pH-sensitive kinase Pyk2 in the kidney proximal tubules was upregulated which might compensate for GPR68 deficiency.58 Taken together, GPR4 and GPR68 may both be necessary for successful systemic pH buffering by controlling renal acid excretion.

Role for the pH-sensing GPCRs in the respiratory system

Aoki et al demonstrated that GPR68-deficient mice were resistant to asthma along with inhibiting Th2 cytokine and immunoglobulin E production.68 This study concludes that GPR68 in dendritic cells is crucial for the onset of asthmatic responses.68 Moreover, GPR65 has been implicated as having a role in respiratory disorders as it is highly expressed in eosinophils, hallmark cells for asthmatic inflammation.69 Kottyan et al showed that GPR65 increased the viability of eosinophils within an acidic environment through the cAMP pathway in murine asthma models.31 In summary, GPR68 and GPR65 play important roles in the respiratory system and asthma. GPR68 regulates gene expression in airway epithelial, smooth muscle and immune cells while GPR65 enhances the survival of airway eosinophils in response to acidosis.

Role for the pH-sensing GPCRs in the skeletal system

GPR65 has also been reported as a pH sensor in bone. GPR65 is expressed in osteoclasts and its activity may inhibit Ca2+ resorption.81 Disruption of GPR65 gene exacerbated osteoclastic bone resorption in ovariectomized mice.81 The relative bone density of GPR65-null mice was less than control mice.81 In cultured osteoclast cells from mice deficient for GPR65, the normal inhibition of osteoclast formation in response to acidosis was abrogated.81 Taken together, this data suggest that the activation of GPR65 may enhance bone density, thus the GPR65 signaling may be important for disease processes such as osteoporosis and other bone density disorders.

Role for the pH-sensing GPCRs in the endocrine system

GPR68 has also been found to modify insulin production and secretion. In GPR68 knockout mice insulin secretion in response to glucose administration was reduced when compared to wild-type mice although blood glucose was not significantly altered.84 GPR68 deficiency in this respect may reduce insulin secretion but at the same time increase insulin sensitivity. In addition, stimulation of GPR68 in islet cells by acidosis increased the secretion of insulin through the Gq/11 G-protein signaling.84

Role for the pH-sensing GPCRs in the nervous system and nociception

Acidosis causes pain by exciting nociceptors located in sensory neurons. Several types of ion channels and receptors, such as ASICs, TRPV1, and proton-sensing GPCRs, have been identified as nociceptors in response to acidosis. ASICs and TRPV act as proton-gated membrane-bound channels, which are activated by acidic pH and mediate multimodal sensory perception including nociception.8688  GPR65 activation sensitized the response of TRPV1 to capsaicin. The results suggest high accumulation of protons post inflammation may not only stimulate nociceptive ion channels such as TRPV1 to trigger pain, but also activate proton-sensing GPCRs to regulate heightened sensitivity to pain.89 Furthermore, Hang et al demonstrated GPR65 activation elicited cancer-related bone pain through the PKA and phosphorylated CREB (pCREB) signaling pathway in the rat model.90 Collectively, GPR4, GPR65, and GPR68 are all expressed in the dorsal root ganglia; GPR65 is a functional receptor involved in nociception and the nervous system by sensitizing inflammatory pain and the evocation of cancer-related bone pain.

Role for the pH-sensing GPCRs in tumor biology

The tumor microenvironment is highly heterogeneous. Hypoxia, acidosis, inflammation, defective vasculature, poor blood perfusion, and deregulated cancer cell metabolism are hallmarks of the tumor microenvironment.9193 The acidity in the tumor microenvironment is owing to the altered cancer cell metabolism termed the “Warburg Effect”. This metabolic phenotype allows the cancer cells to preferentially utilize glycolysis over oxidative phosphorylation as a primary means of energy production.94 This process occurs even in normoxic tissue environments where sufficient oxygen is available. Due to this phenomenon, the Warburg Effect is often termed “aerobic glycolysis”. This unique metabolic phenotype produces vast quantities of lactic acid, which serve as a proton source for acidification. Upon disassociation of lactic acid to one lactate molecule and one proton, the monocarboxylate transporter and proton transporters export lactate and protons into the extracellular tumor microenvironment.95 The proton-sensing GPCRs are activated by acidic pH and facilitate tumor cell modulation in response to extracellular acidification. GPR4, GPR65, and GPR68 play roles in tumor cell apoptosis, proliferation, metastasis, angiogenesis, and immune cell function.19,27,32,33,44,45,96,97

GPR4 has had conflicting reports in terms of tumor suppressing or promoting activities. One study demonstrated that GPR4 could act as a tumor metastasis suppressor, when overexpressed and activated by acidic pH in B16F10 melanoma cells, by impeding migration and invasion of tumor cells.45 GPR4 overexpression also significantly inhibited the lung metastasis of B16F10 melanoma cells in mice.45 Another study utilizing the B16F10 melanoma cell line which overexpressed GPR4 showed an increase in mitochondrial surface area and a significant reduction in membrane protrusions by quantification of 3D morphology.98 These data point to a decrease in cancer cell migration when GPR4 is overexpressed and provides another example of GPR4 as exhibiting tumor metastasis suppressor function.98 However, in another report GPR4 malignantly transformed immortalized NIH3T3 fibroblasts.99 This presents GPR4 with tumor-promoting capabilities. The conflicting reports seem to indicate the functional ability of GPR4 to act as a tumor promoter and a tumor suppressor depending on the context of certain cell types and biological systems.

Reports with GPR65 involvement in cancer cells provide evidence in favor for cancer cell survival; however, opposing evidences suggest GPR65 functions as a tumor suppressor. In the same report suggesting GPR4 is oncogenic due to GPR4 transforming immortalized NIH3T3 fibroblasts, GPR65 overexpression was able to transform the mouse NMuMG mammary epithelial cell line.99 Another group demonstrated in NCI-H460 human non-small cell lung cancer cells that GPR65 promotes cancer cell survival in an acidic microenvironment.100 Conversely, a recent study showed that GPR65 inhibited c-Myc oncogene expression in human lymphoma cells.101 Furthermore, GPR65 messenger ribonucleic acid expression was reduced by more than 50% in a variety of human lymphoma samples when compared to normal lymphoid tissues, therefore implying GPR65 has a tumor suppressor function in lymphoma.101 GPR65 has also been shown to increase glucocorticoid-induced apoptosis in murine lymphoma cells.102 These reports highlight cell type dependency and biological context for GPR65 activity as a tumor suppressor or promoter.

GPR68 also has roles in tumor biology as a potential tumor suppressor or a tumor promoter. Reports have shown that GPR68 can inhibit cancer metastasis, reduce cancer cell proliferation, and inhibit migration. One study showed that when GPR68 was overexpressed in prostate cancer cells, metastasis to the lungs, diaphragm, and spleen was inhibited.97 When GPR68 was overexpressed in ovarian cancer (HEY) cells, cellular proliferation and migration were significantly reduced, and cell adhesion to the extracellular matrix was increased.96 Another study reported GPR68 expression was critical for the tumor cell induced immunosuppression in myeloid-derived cells. This study proposed that GPR68 promotes M2 macrophage development and inhibits T-cell infiltration, and thereby facilitates tumor development.103 In summary, the biological roles of GPR4, GPR65, and GPR68 in tumor biology are complex and both tumor-suppressing and tumor-promoting functions have been reported, primarily dependent on cell type and biological milieu.

Development of small molecule modulators of the pH-sensing GPCRs

GPCRs are critical receptors for the regulation of many physiological operations. It is of little surprise that GPCRs have become a central focus of pharmaceutical development. In fact, 30%–50% of therapeutics focuses on modulating GPCR activity.104,105 In view of the diverse roles of the pH-sensing GPCRs in the context of multiple biological systems, targeting these receptors with small molecules and other modulators could serve as potential therapeutics for diseases associated with deregulated pH homeostasis. There have been recent developments in the characterization of GPR4 antagonists along with agonists for GPR65 and GPR68.29,32,50,106 The GPR4 antagonist demonstrated effectiveness in vitro to reduce the GPR4-mediated inflammatory response to acidosis in endothelial cells.32 The GPR65 agonist, BTB09089, showed in vitro effects in GPR65 activation of immune cells to inhibit inflammatory response; however, the activity of BTB09089 was not strong enough for the use in animal models in vivo.29 The GPR68 agonist, lsx, exhibited pro-neurogenic activity and induced hippocampal neurogenesis in young mice.107 It was also demonstrated that lsx suppressed the proliferation of malignant astrocytes.108 To date, however, much advancement needs to be done in development of efficacious agonists and antagonists of the pH-sensing GPCRs coupled with a capacity to target specific tissue dysfunction in the midst of systemic drug administration to optimize therapeutic effects and minimize potential adverse effects.

Concluding remarks

Cells encounter acidotic stress in many pathophysiologic conditions such as inflammation, cancer, and ischemia. Intricate molecular mechanisms, including a large array of acid/base transporters and acid sensors, have evolved for cells to sense and respond to acidotic stress. Emerging evidence has demonstrated that a family of the pH-sensing GPCRs can be activated by extracellular acidotic stress and regulate the function of multiple physiological systems (Table 1). The pH-sensing GPCRs also play important roles in various pathological disorders. Agonists, antagonists and other modulators of the pH-sensing GPCRs are being actively developed and evaluated as potential novel treatment for acidosis-related diseases.

Table 1 The main biological functions of the pH-sensing GPCRs

7.3.9 Protein amino-terminal modifications and proteomic approaches for N-terminal profiling

Lai ZW1, Petrera A2, Schilling O3.
Curr Opin Chem Biol. 2015 Feb; 24:71-9
http://dx.doi.org:/10.1016/j.cbpa.2014.10.026

Amino-/N-terminal processing is a crucial post-translational modification affecting almost all proteins. In addition to altering the chemical properties of the N-terminus, these modifications affect protein activation, conversion, and degradation, which subsequently lead to diversified biological functions. The study of N-terminal modifications is of increasing interest; especially since modifications such as proteolytic truncation or pyroglutamate formation have been linked to disease processes. During the past decade, mass spectrometry has played an important role in facilitating the investigation of N-terminal modifications. Continuous progress is being made in the development and application of robust methods for the dedicated analysis of native and modified protein N-termini in a proteome-wide manner. Here we highlight recent progress in our understanding of protein N-terminal biology as well as outlining present enrichment strategies for mass spectrometry-based studies of protein N-termini.

Highlights

    • N-terminal acetylation, pyroglutamate formation, N-degrons and proteolysis are reviewed.• N-terminomics provide comprehensive profiling of modification at protein N-termini in a proteome-wide manner.• We outline a number of established methodologies for the enrichment of protein N-termini through positive and negative selection strategies.• Peptidomics-based approach is beneficial for the study of post-translational processing of protein N-termini.

 Introduction The life of every protein begins at the amino-terminus, also known as the N-terminus. During the initiation of mRNA translation into proteins or polypeptides, newly synthesized amino
acid chains form the N-termini and are the first to exit the ribosomes into the cytosol or the endoplasmic reticulum. The N-termini of these proteins or protein precursors often contain a signaling peptide
sequence proximal to the N-terminus, which may function as a ‘zip-code’ to direct the delivery of a protein to a cellular compartment as well as orchestrating protein maturation via different post-translational
modifications (PTMs) such as acetylation or proteolysis. These modifications often determine protein activity or stability; thus being crucial for the tight regulation of cellular homeostasis (Figure 1).
Mass spectrometry (MS) based analyses of protein N-termini, termed N-terminomics, is a promising tool to tackle these problems. In the past decade, we have witnessed significant progress in the
area of mass spectrometric investigation of post-translational modifications such as phosphorylation or glycosylation [1].  Similarly, MS-based studies of protein N-termini are gaining momentum.
Recent progress in positional proteomics using advanced MS platforms combined with a number of effective enrichment strategies has reinforced significant interest in N-terminomics.
Here we outline some of the most current highlights on proteomics-based studies on N-terminal modifications, including N-acetylation, pyroglutamate formation, proteolysis, and N-terminal degrons
(Figure 2). We also present a number of recent N-terminomic methodologies for the study of protein N-termini.

Acetylation of protein N-termini represents an abundant post-translational modification in eukaryotes, affecting nearly all cytoplasmic proteins. This  modification is catalyzed by the N-terminal
acetyltransferase (Nat) enzyme complex, which transfers an acetyl group to the N-termini of newly synthesized proteins during translation (Figure 2). Initial findings highlighted that N-terminal
acetylation protects proteins from degradation [2–4]. Recent studies however yield a more diverse picture. N-terminal acetylation may also play a role in protein delivery and localization [5–7],
protein complex formation and generation of specific degradation signals in cellular proteins via the N-degron pathway [9,10]. Loss of N-terminal acetylation through inactive acetyltransferases leads to
smaller aggregates of prion proteins [11]. In addition, N-terminal acetyltransferases have been described to also function as N-terminal proprionyltransferases [12].  Genetic mutation in the Naa10 gene,
encoding the NatA catalytic subunit, is known to cause N-terminal acetyltransferase deficient phenotypes. This genetic mutation has also been linked to X-linked disorder of infancy, causing lethality in
male infants[13]. The multifunctional roles of N-acetyltransferases as well as the importance of  N-terminal acetylation have been previously reviewed in [14]. Few MS-based studies have emerged that
specifically investigate acetylated N-termini in a proteome wide manner. The structural and functional integrity of actomyosin fibers depends on active NatB. A novel methodology determines the
extent of N-terminal acetylation in vivo through chemical, stable-isotope coded acetylation of proteins before their mass spectrometric analysis [16].

Pyroglutamate conversion of N-terminal glutamate and glutamine Many proteins and biologically active peptides exhibit an N-terminal pyroglutamic acid (pGlu) residue. This post
translational modification originates from the conversion of N-terminal glutamate and glutamine into pyroglutamic acid by glutaminyl cyclase or isoglutaminyl cyclase (Figure 2). N-terminal
pGlu influences structural stability as well as biological activity of peptides and proteins [17]. pGlu protects proteins from degradation by aminopeptidases [18] as well as regulating the
biological activity of peptide hormones, neuropeptides or chemokines [19]. Examples include thyrotropin releasing hormone (TRH), gonadotropin-releasing hormone, and the human
chemokines MCP-1 and 2. The presence of N-terminal pGlu in some amyloidogenic peptides, such as amyloid-b peptides, increases their hydrophobicity, resulting in an accelerated
aggregation [20]. Modulating the extent of N-terminal pGlu formation through pharmaceutical inhibition of glutaminyl cyclase is considered a promising strategy, for example, to
increase the degradation of inflammatory and neurotoxic peptides. Inhibition of glutaminyl cyclase has alleviated liver inflammation by destabilizing the chemokine MCP1 (CCL2) [21].
Proteolytic degradation of this promigratory chemokine by inhibiting glutaminyl cyclase was also proposed as an attractive novel strategy in preventing thyroid cancer metastasis [22].
Given the functional relevance of N-terminal pGlu in pathological conditions, an MS-based approach to profile this modification may be particularly useful.

N-terminal degrons N-terminal residues have a strong impact on protein stability and half-life. Firstly described in 1986 by Varshavsky and colleagues [25], the N-end rule pathway
has been identified in a broad range of species, from mammals to bacteria, and from yeast to plants [26]. This control of protein degradation in eukaryotes and bacteria is governed
by the formation and recognition of specific sequences at protein N-termini, called N-degrons. The main determinant of an N-degron is an N-terminal destabilizing residue. In eukaryotes,
two N-end rule pathways are being distinguished: the Ac/N-end rule pathway targets proteins through their N-terminally acetylated residues while the Arg/N-rule pathway targets
unacetylated N-terminal residues and involves N-terminal arginylation [26]. Proteolytic processing leading to new protein N-termini is increasingly recognized to play an important
role in the formation of N-degrons. In eukaryotes, N-degron mediated protein degradation occurs through the  ubiquitin–proteasome system. N degrons are recognized by E3
ubiquitin ligases called N-recognins, which induce protein ubiquitylation. Recent studies showed that the N-end rule pathway can be regulated by various mechanisms [26].
Hemin, the ferric (Fe3+) counterpart of heme, and short peptides can bind to components of the N-end rule pathway and impede their functionality [26]. Although the N-end rule
pathway has been molecularly dissected in great detail, numbers of identified physiological substrates undergoing N-end rule degradation have remained limited. A recent study
has expanded the range of substrates targeted by the Arg/N-end rule. Kim and colleagues have shown that N terminal Met followed by a hydrophobic residue functions as an N-degron
[27]. N-terminal Met followed by a small residue is typically removed by aminopeptidases in a cotranslational manner (Figure 2). However, approximately 15% of the genes in mammals
or yeast encode for an N-terminal Met followed by a larger hydrophobic residue. This specific N-degron is targeted by the Ac/N-end rule pathway when the N-terminal Met is acetylated.
The Arg/N-end rule acts instead on the non-acetylated N-terminal Met. As previously mentioned, novel N-degrons can be generated by preceding proteolysis. Piatkov and colleagues
investigated this concept for proteolytic cleavage products that occur during apoptosis [28]. They find that numerous proapoptotic fragments are short lived substrates of Arg/N-end
rule pathway, attributing to this pathway an anti-apoptotic role. Notably, the corresponding N-degron sequences are evolutionary conserved.

Figure 1 Protein N-termini are susceptible to various post-translational modification.
For a more comprehensive overview of all possible N terminal modification, see [60].

Figure 2 Examples of N-terminal mofications: acetylation, pyroglutamate conversion, proteolysis and N-degron processing via deamidation and amino acid conjugation.

Proteolytic processing of N-termini Proteolysis has long been regarded a degradation process. It is now increasingly recognized as an important posttranslational modification
with an array of proteases mediating cellular signaling via the precise processing of bioactive proteins and peptides. The study of cleavage events using N-terminomics is particularly
useful for the identification of proteolytic substrates. Proteolytic cleavage of proteins and polypeptides results in the generation of cleavage fragments with new N-termini and
C-termini. Numerous recent proteomic studies highlighted differential regulation of proteases in different disease settings. MALDI-TOF in combination with enzymatic assays
established reduced levels of dipeptidyl-peptidase (DPP)4 in the serum of patients suffering from metastatic prostate cancer [31]. Another proteomic based study,  using isotope
coded affinity tag (ICAT) labeling showed bacterial leucine aminopeptidase from Plasmodium chabaudi to be significantly upregulated in periodontal disease [32]. Mass spectrometry
was also used for the functional characterization of proteases.

7.3.10 Protein homeostasis networks in physiology and disease

Although most text books of biochemistry describe the process of protein folding to a three dimensional native state as an intrinsic property of the primary sequence, it is becoming increasingly clear that this process can go wrong in an almost infinite number of ways. In fact, many different diseases are caused by the misfolding and aggregation of certain proteins without genetic mutations in the primary sequence. An integrative view of the mechanisms that maintain protein folding homeostasis is emerging, which could be thought as a balanced and dynamic network of interconnected processes tightly regulated by a series of quality control mechanisms. This protein homeostasis network involves families of folding catalysts, co-factors under specific environmental and metabolic conditions. Maintaining protein homeostasis is particularly challenging in specialized secretory cells where the high demand for protein synthesis generates a constant source of stress that could lead to proteotoxicity.

Protein folding is assisted and monitored by diverse interconnected processes that follow a sequential pattern over time. The calnexin/calreticulin cycle ensures the proper folding of glycosylated proteins through the secretory pathway, which establishes the final pattern of disulfide bond formation through interactions with the disulfide isomerase ERp57. Coupled to this cycle is the ER-associated degradation (ERAD) pathway, which translocates terminally misfolded proteins to the cytosol for degradation by proteasomes. In addition, macroautophagy is becoming a relevant mechanism for the clearance of damaged proteins and abnormal protein aggregates through lysosomal hydrolysis, a process also referred to as ERAD-II. The folding status at the ER is constantly monitored by the Unfolded Protein Response (UPR), a specialized signaling pathway initiated by the activation of three types of stress sensors. The process underlying the surveillance of protein folding stress by the UPR is not fully understood, but it may require coupling to key folding mediators such as BiP or the direct recognition of the misfolded peptides by stress sensors. The UPR regulates genes and processs related to almost every folding step in the secretory pathway to reduce the load of misfolded proteins, including protein translation into the ER, translocation, folding, quality control, ERAD, the redox status, and many other related functions. Protein folding stress is observed in many disease conditions such as cancer, diabetes, and neurodegeneration. For example, abnormal protein aggregation and the accumulation of protein inclusions is associated with Parkinson’s and Alzheimer’s Disease, and amyotrophic lateral sclerosis. In those diseases and many others, neuronal dysfunction and disease progression correlates with the presence of a strong ER stress response; however, the direct in vivo role of the UPR in the disease process has been experimentally defined in only a few cases. Therapeutic strategies are currently being developed to increase protein folding and clearance of misfolded proteins, with the goal of alleviating ER stress.

In this issue of Current Opinion in Cell Biology we present a series of focused reviews from recognized experts in the field, that provide an overview of mechanisms underlying protein folding and quality control, and how balance of protein homeostasis is maintained in physiology and deregulated in diseases. Daniela Roth and William Balch integrate the concept of protein homeostasis networks into an interesting model termed FoldFx, showing how the interconnection between different pathways in the context of the cellular proteome determines the energetic barrier required to generate a functional folded peptide. The authors have previously proposed the term Proteostasis to refer to the set of interacting activities that maintain the health of the proteome and the organism (protein homeostasis). The ER is a central subcellular compartment for protein synthesis and quality control in the secretory pathway. Yukio Kimata and Kenji Kohno give an overview of the signaling pathways that control adaptation to ER stress and maintenance of protein folding homeostasis. The authors summarize the models proposed so far for the activation of UPR stress sensors, and discuss how this directly or indirectly relates to the accumulation of unfolded proteins in the ER lumen. Chronic or irreversible ER stress triggers cell death by apoptosis. Gordon Shore, Feroz Papa, and Scott Oakes summarize the complex signaling pathways initiating apoptosis by ER stress, where cross talk between the ER and the mitochondria play a central role. The authors focus on addressing the role of the BCL-2 protein family on the activation of intrinsic mitochondrial apoptosis pathways, highlighting different cytosolic and transcriptional events that determine the transition between adaptive responses to apoptosis programmed by the UPR to eliminate irreversibly injured cells.

Although diverse families of chaperones, foldases and co-factors are expressed at the ER, only a few protein folding networks have been well defined. However, molecular explanations for specific substrate recognition and quality control mechanisms are poorly defined. Here we present a series of reviews covering different aspects of protein maturation. Amy Lee summarizes what is known about the biology of the key ER folding chaperone BiP/Grp78, and its emerging role in diverse pathological conditions including cancer. In two reviews, David B. Williams and Linda M. Hendershot describe the best characterized mechanism of protein quality control at the ER, the calnexin cycle. In addition, they give an overview of the function of a family of ER foldases, the protein disulfide isomerases (PDIs), in folding, quality control and degradation of abnormally folded proteins. PDIs are also becoming key factors in establishing the redox tone of the ER. Riccardo Bernasconi and Maurizio Molinari overview the ERAD process and how this pathway affects the efficiency of the protein folding process at the ER and its relation to pathological conditions.

Lysosomal-mediated degradation is becoming a fundamental process for the control of the haft-life of proteins and the degradation of misfolded, aggregate prone proteins. Ana Maria Cuervo reviews the relevance of Chaperone-mediated autophagy in the selective degradation of soluble cytosolic proteins in lysosomes, and also points out a key role for Chaperone-mediated autophagy in the cellular defense against proteotoxicity. David Rubinsztein and Guido Kroemer present two reviews highlighting the emerging relevance of macroautophagy in maintaining the homeostasis of the nervous system. They also discuss the actual impact of macroautophagy in the clearance of protein aggregates related to neurodegenerative diseases, including Parkinson’s disease, amyotrophic lateral sclerosis, Huntington’s disease among others. In addition, recent evidence suggesting an actual impairment of macroautophagy as a causative factor in aging-related disorders is also discussed.

Alterations in protein homeostasis underlie the etiology of many diseases affecting the nervous system, in addition to cancer and diabetes. Fumiko Urano summarizes the impact of ER stress in β cell dysfunction and death during the progression of type 1 and type 2 diabetes, as well as in genetic forms of diabetes such as Wolfram syndrome. The occurrence of basal ER stress is observed in specialized secretory cells and organs, including plasma B cells. Roberto Sitia covers several aspects of how proteotoxic stresses physiologically contribute to regulate the biogenesis, function and lifespan of B cells, and speculates about the possible impact of ER stress in the treatment of multiple myeloma. Claudio Soto describes the specific role of calcineurin, a key phosphatase in the brain, in the occurrence of synaptic dysfunction and neuronal death in prion-related disorders. We also present provide a review summarizing the emerging role of ER stress and the UPR in most neurodegenerative diseases related to protein misfolding. We also discuss the particular mechanisms currently proposed to be involved in the generation of protein folding stress at the ER in these pathologies, and speculate about possible therapeutic interventions to treat neurodegenerative diseases.

Strategies to increase the efficiency of quality control mechanisms, to reduce protein aggregation and to enhance folding are suggested to be beneficial in the setting of diseases associated with the disruption of protein homeostasis. Finally, Jeffery Kelly overviews recent chemical and biological therapeutic strategies to restore protein homeostasis, which could be achieved by enhancing the biological capacity of the proteostasis network or through small molecule to stabilize misfolding-prone proteins. In summary, this volume ofCurrent Opinion in Cell Biology compiles the most recent advances in understanding the impact of protein folding stress in physiology and disease, and integrates a variety of complex mechanisms that evolved to maintain protein homeostasis in a dynamic way in the context of a changing environment. The biomedical applications of developing strategies to cope with protein folding stress have profound implications for the treatment of the most prevalent diseases in the human population.

7.3.11 Proteome sequencing goes deep
Advances in mass spectrometry (MS) have transformed the scope and impact of protein characterization efforts. Identifying hundreds of proteins from rather simple biological matrices, such as yeast, was a daunting task just a few decades ago. Now, expression of more than half of the estimated ∼20,000 human protein coding genes can be confirmed in record time and from minute sample quantities. Access to proteomic information at such unprecedented depths has been fueled by strides in every stage of the shotgun proteomics workflow-from sample processing to data analysis-and promises to revolutionize our understanding of the causes and consequences of proteome variation.
Highlights
    • Recent MS advances have transformed the depth of coverage of the human proteome.• Expression of half the estimated human protein coding genes can be verified by MS.• MS sample preparation, instrumentation, and data analysis techniques are highlighted.

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Mammalian proteomes  are complex [3]. The human proteome contains ~20,300 protein-coding genes; however, non-synonymous single nucleotide polymorphisms (nsSNPs), alternative
splicing events, and post-translational modifications (PTMs) all occur and exponentially increase the number of distinct proteoforms [4–6]. Detection of 5000 proteins in a proteomic
experiment was a considerable achievement just a few years ago [7–9]. More recently, two groups identified over 10,000 protein groups in a single experiment. Through extensive protein
and peptide fractionation (72 fractions) and digestion with multiple enzymes, Nagaraj et al. identified 10,255 protein groups from HeLa cells over 288 hours of instrument analysis [10].
A comparison with paired RNA-Seq data revealed nearly complete overlap between the detected proteins and the expressed transcripts. In that same year, a similar strategy enabled
the identification of 10,006 proteins from the U2OS cell line [11]. Kim and co-workers analyzed 30 human tissues and primary cells over 2000 LC–MS/MS experiments, resulting
in the detection of 293,000 peptides with unique amino acid sequences and evidence for 17,294 gene products [16]. Wilhelm et al. amassed a total of 16,857 LC–MS/MS experiments
from human cell lines, tissues, and body fluids. These experiments produced 946,000 unique peptides, which map to 18,097 protein coding genes [17]. Together, these two studies
provide direct evidence for protein translation of over 90% of  human genes (Figure 2). New developments in mass spectrometer technology have increased the rate at which proteomes
can be analyzed. We describe developments in sample preparation, MS instrumentation, and bioinformatics that have been key to obtaining comprehensive proteomic coverage.
Further, we consider how access to such proteomic detail will impact genomic  research.

Aurelian Udristioiu

Aurelian

Aurelian Udristioiu

Lab Director at Emergency County Hospital Targu Jiu

Mg²+ is critical for maintaining the positional integrity of closely clustered phosphate groups. These clusters appear in numerous and distinct parts of the cell nucleus and cytoplasm. The Mg²+ ion maintains the integrity of nucleic acids, ribosomes and proteins. In addition, this ion acts as an oligo-element with role in energy catalysis. Biological cell membranes and cell walls exhibit poly-anionic charges on the surface. This finding has important implications for the transport of ions, particularly because different membranes preferentially bind different ions. Both Mg²+ and Ca²+ regularly stabilize membranes by cross-linking the carboxylated and phosphorylated head groups of lipids.

Notable document –

Theor Biol Med Model. 2010 Jun 9;7:19.
Native aggregation as a cause of origin of temporary cellular structures needed for all forms of cellular activity, signaling and transformations.
Matveev VV1.
Cell physiologist at Institute of Cytology, Russian Academy of Sciences

According to the hypothesis explored in this paper, native aggregation is genetically controlled (programmed) reversible aggregation that occurs when interacting proteins form new temporary structures through highly specific interactions. It is assumed that Anfinsen’s dogma may be extended to protein aggregation: composition and amino acid sequence determine not only the secondary and tertiary structure of single protein, but also the structure of protein aggregates (associates). Cell function is considered as a transition between two states (two states model), the resting state and state of activity (this applies to the cell as a whole and to its individual structures). In the resting state, the key proteins are found in the following inactive forms: natively unfolded and globular. When the cell is activated, secondary structures appear in natively unfolded proteins (including unfolded regions in other proteins), and globular proteins begin to melt and their secondary structures become available for interaction with the secondary structures of other proteins. These temporary secondary structures provide a means for highly specific interactions between proteins. As a result, native aggregation creates temporary structures necessary for cell activity.”One of the principal objects of theoretical research in any department of knowledge is to find the point of view from which the subject appears in its greatest simplicity.”Josiah Willard Gibbs (1839-1903).

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To date, numerous mechanisms, signal pathways, and different factors have been found in the cell. Researchers are naturally eager to find commonalities in the mechanisms of cellular regulation. I would like to propose a substantial approach to problems of cell physiology – the structural ground that produces signals and underlies the diversity of cellular mechanisms.

The methodological basis for the proposed hypothesis results from studies by the scientific schools of Dmitrii Nasonov [1] and Gilbert Ling [26], which have gained new appreciation over the last 20-30 years owing to advances in protein physics [7] in the study of properties of globular proteins, their unfolding and folding, as well as the discovery of novel states of the protein molecule: the natively unfolded and the molten globule. The key statement for the rationale of the present paper is that the specificity of interactions of polypeptide chains with each other (at the intra- and inter-molecular levels) can be provided only by their secondary structures, primarily α-helices and β-sheets.

Nasonov’s school discovered and studied a fundamental phenomenon — the nonspecific reaction of the cell to external actions [1], while works by Ling [5] and his followers allow the mechanisms of this phenomenon to be understood.

The above-mentioned cell reaction has been called nonspecific because diverse physical and chemical factors produce the same complex of structural changes in the cell: an increase in the turbidity and macroscopic viscosity of the cytoplasm and in the adsorption of hydrophobic substances by cytoplasmic proteins. It is of primary importance that the same changes also occur in the cell during its transition into the active state: muscle contraction, action potential, enhancement of secretory activity (for details, see [8]). Hence, from the point of view of structural changes, there is no fundamental difference between the result of action on the cell of hydrostatic pressure and, for instance, muscle contraction. In both cases, proteins are aggregated.

Nasonov called the cause of these changes the stages of cell protein denaturation, as the changes of properties of isolated proteins during denaturation are very similar to the changes in the cytoplasm during the nonspecific reaction. As a result, the denaturational theory of cell excitation and damage was created [1]. The structural changes of protein denaturation were unclear in Nasonov’s time. Nowadays, it is assumed that the denaturation is the destruction of the tertiary and secondary structure of a protein. Below I give two definitions, for the denaturation of natively folded (globular) proteins and for natively unfolded proteins.

A key notion in physiology is the resting state of the cell. This is implicit in the concept of the threshold character of the action of stimuli on the cell, which has played a historical role in the development of physiological science. It is the threshold that is the boundary between two states — rest and activity. But in effect, all our knowledge about cells concerns active cells, not cells in the resting state. It is in the active cell that variable changes occur that can be recorded. Nothing happens in the resting cell, so there is nothing to be recorded in it. Nevertheless, it is obvious that the resting state is the initial cell state, the starting point for all changes occurring in the cell.

What characterizes the structural aspect of the cell in the state of rest? It is only in Ling’s work [5] that I have found a clear answer to this question. The answer can be interpreted as follows: if all resting cell proteins were arranged in one line, it would turn out that most of the peptide bonds in this superpolypeptide would be accessible to solvent (water), while only a few would be included in secondary structures. When the cell is activated, the ratio between the unfolded and folded areas is changed sharply to the opposite: the proportion of peptide bonds accessible to solvent decreases markedly, whereas the proportion included in secondary structures rises significantly. These two extreme states of cell proteins, suggested by Ling, provide a basis for further consideration.

If Ling’s approach is combined with Nasonov’s theory, we obtain several interesting consequences. First of all, it is clear that proteins with maximally unfolded structures form the structural basis of resting cells because they are inactive, i.e., do not interact with other proteins or other macromolecules. The situation changes when an action on the cell exceeds the threshold: completely or partially unfolded key proteins begin to fold when new secondary protein structures are formed. Owing to these new secondary structures, the proteins become capable of reacting, i.e., intramolecular aggregation (folding of individual polypeptides into globules) and intermolecular aggregation (interaction of some proteins with others) begin. A distinguishing feature of these aggregational processes is their absolutely specific character, which is ensured by the amino acid composition, shape, and size of the secondary structures. The structures appearing have physiological meaning, so such aggregation is native and the secondary structures causing it are centers of native aggregation. Another source of secondary structures necessary for native aggregation is the molten globule.

The ability of cells to return to the initial state, the state of rest, means that native aggregation is completely reversible, and the structures appearing in the course of native aggregation are temporary and are disassembled as soon as they cease to be necessary. Native aggregation can involve both the whole cell and individual organelles, compartments, and structures, and activation of proteins is of a threshold rather than a spontaneous character.

The meaning of the proposed hypothesis of native aggregation is that the primary cause of any functional changes in cell is the appearance, as a result of native aggregation, of temporary structures, continually appearing and disintegrating during the life of the cell. Since native aggregation is initiated by external stimuli or regulatory processes and the structures appearing have a temporary character, these structures can be called signal structures.

Signal structures can have different properties: (i) they can be centers of binding of ions, molecules (solutes), and proteins; (ii) they can have enzymatic activity; (iii) they can form channels and intercellular contacts; (iv) they can serve as matrices organizing the interactions of molecules in synthetic and transport processes; (iv) they can serve as receptors for signal molecules; (v) they can serve as the basis for constructing even more complex supramolecular structures. These structures “flash” in the cell space like signal lights, perform their role, and disappear, to appear in another place and at another time. The meaning of the existence of the structural “flashes” is that during transition into the active state the cell needs new resources, functions, mechanisms, regulators, and signals. As soon as the cell changes to the resting state, the need for these structures disappears, and they are disassembled. Extreme examples of native aggregation are muscle contraction, condensation of chromosomes, the appearance of the division spindle, and interactions of ligands with receptors.

Thus, the present paper will consider the meaning and significance of native aggregation as the universal structural basis of the active cell. The basis of pathological states is the inability of the cell to return to the resting state and errors in the formation of signal structures. The presentation of native aggregation is based on three pillars: (i) reversible protein aggregation is a structural basis of cell activity (Nasonov’s School); (ii) the operation of the living cell or its individual structures can be regarded as a repetitive sequence of transitions between two states (active and resting), a key role in which belongs to natively unfolded proteins (Ling’s approach); (iii) the specificity of interactions of separate parts of a single polypeptide chain with each other (folding) or the interaction of separate polypeptide chains among themselves (self-assembly, aggregation) can be provided only by protein secondary structures.

The goal of this paper is the enunciation of principles, rather than a review of facts corresponding to these principles.

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