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Real Time Conference Coverage: Advancing Precision Medicine Conference, Afternoon Session Track 1 October 3 2025

Reporter: Stephen J. Williams, PhD

Leaders in Pharmaceutical Business Intellegence will be covering this conference LIVE over X.com at

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using the following meeting hashtags

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WIN SYMPOSIUM

1:50-4:05

SESSION 4

From Targets to Trials:
Translating Discovery into Impact

1:50-2:10

Beyond Checkpoint Inhibitors: Targeted Immunotherapeutic Approaches for the Management of Solid Tumors

Andrea Ferreira-Gonzalez
  • we need to turn these immuno-cold tumors into immuno ‘hot’ tumors so immunotherapy will be effective and recognize them
  • however each immunotherapies have their own toxicities
  • immunocheck points inhibitors: 50% of patients get very rough adverse events and have to stop therapy and give immunosuppressives
  • 60 yo female with urothelial carcinoma with chemo induced rash given pembrolizumab but got worse rash… had Steven Johnson Syndrome… fatal outcome from one cycle of PD-L1 inhibitor
  • so now we are giving these immune checkpoints earlier before even surgery… the overall survival better but there are certain personalized toxicities
  • up to 35% patients with cancer have chronic immuno related adverse events and dose limiting toxicities
  • 50% have low grade multiple toxicities (and they treat these AEs with steroids)
  • we have no biomarkers for these PD/PDL1 inhibitor adverse events

 

2:10-2:30

Implementing Molecular Profiling in Early Phase Clinical Trials: Precision from Bench to Bedside

Andrea Ferreira-Gonzalez
  • power of biomarkers: BRCA2 null women with ovarian cancer success with olaparib even though at time was not approved except the biomarker known
  • every week they discuss with internal tumor board and consult with Foundation Medicine; however a mutational panel is great but need to understand the underlying effect on tumor biology
  • there are a handful of tumor agnostic targeted agents: based on biomarkers
  • she thinks digital twins will be helpful in determining cohort selection for clinical trails
  • she would like multiomics to be performed on every patient but how would this be done, especially in the ecosystem of the USA
  • from attendee question to speaker panel (from Indai): they have been running tmolecular boards but problem is when new targets or fusion proteins become known without a priori knowledge of them and no combination know what to do?

 

:30-2:40

Q&A

Andrea Ferreira-Gonzalez
Andrea Ferreira-Gonzalez

2:40-3:20

Non- CME Session: Venture Philanthropy

Andrea Ferreira-Gonzalez

Eric Heil, MBAManaging PartnerMedical Excellence Capital

  • started a venture fund and then a 501(c) to give small grants
  • in venture philanthropy it is not traditional grant writing but more of a personal relationship; he says find other companies they have backed and ask them
  • all about networking
  • looked at 1400 deals but only invested in 13
  • back years ago his company biotech got ten million after 2009 from TAP but now it seems smaller bridge money
John Lehr, President & CEO, Parkinson's Foundation

John LehrPresident & CEOParkinson’s Foundation

  • runs venture philanthropy which is more like a mix of venture fund and granting agency
  • most run a for profit venture but mix model with 501c to fund small grants
Dr. Blaine Robinson

Dr. Blaine Robinson, PhDVice President of the Therapy Acceleration Program (TAP)Blood Cancer United

  • runs Blood Cancer United that offers grants for blood based research
  • they run three pillars: venture biotech funding, clinical trial funding, and academic research but most they take equity in biotechs
  • so venture philanthropy is more of equity investing and using those funds to fund younger companies like bridge between first round and series C
  • Blood Cancer United looking for million and above investment “first in class’; was early with Kite and UPenn (where are they now… are they still with them?)

3:20-4:10

eNSCLC Testing

Andrea Ferreira-Gonzalez
  • lung cancer has seemed to be ahead with respect to biomarkers and precision therapies
  • at least with NCCN guidelines they are up to 14 therapeutic biomarkers not diagnostic biomarkers so very ahead on the clinical decision making on actionable mutations for lung cancer
  • so most of the testing is genomic mutational spectrum for oncogenic drivers
  • there are three protein based biomarkers: Met, PDL1,
  • FISH is still used for some fusions
  • NGS is more sensitive test but takes 2-4 weeks
  • the number of  detected EGFR variants are increasing so it is affecting the drug specificity
  • recently NRG1 fusions have been approved as a heregulin HER3 biomarker;
  • 15% which were detected as negative for fusions the patients actually responded because fusions were hard to detect; many false positives
  • 76% did not meet MET eligbility but only 13% were high enough for MET marker but was enough for FDA approval
  • some drugs beneficial for mutated version and some good for over expressed like MET or HER2 but where the mutation or exon skipping is important for therapy choice
  • we need better biobanking because we need more tissue; we loose more tissue during sectioning and not splitting blocks into two (one for diagnostic one for therapeutic)
  • liquid biopsy will find some mutations but other ones not very sensitivity in liquid biopsy like MET mutations (mutations may be assay specific)
  • some muts in bone marrow may just be in aging progenitor cells and sometimes in oncogene like BRAF but not cancer but dlonal homatopoesis (increased risk for myeloproliferative diseases but not solid tumors like melanoma)
  • clonal homatopoesis actually common so watch out when just relying on liquid biopsy

 

 

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Head and Neck Cancer Studies Suggest Alternative Markers More Prognostically Useful than HPV DNA Testing

Reporter: Aviva Lev-Ari, PhD, RN

September 18, 2012
 

NEW YORK (GenomeWeb News) – The presence or absence of human papillomavirus DNA on its own in an individual’s head or neck cancer does not provide enough information to help predict a patient’s survival, according to a pair of new papers in the journal Cancer Research.

Two research teams — headed by investigators at Brown University and Heidelberg University, respectively — looked at the reliability of using PCR-based HPV testing to determine which head and neck squamous cell carcinomas were HPV-related and, thus, more apt to respond to treatment.

Previous studies have shown that individuals with HPV-associated head and neck cancers tend to have more favorable outcomes than individuals whose head and neck cancers that are not related to HPV infection.

“Everybody who has studied it has shown that people with virally associated disease do better,” Brown University pathology researcher Karl Kelsey, a senior author on one of the new studies, explained in a statement.

“There are now clinical trials underway to determine if they should be treated differently,” he added. “The problem is that you need to appropriately diagnose virally related disease, and our data suggests that people need to take a close look at that.”

For their part, Kelsey and his co-authors from the US and Germany assessed the utility of testing for the presence of HPV by various means in individuals with head and neck cancer. This included PCR-based tests for HPV DNA in the tumor itself, tests aimed at detecting infection-associated antibodies in an individual’s blood, and tests for elevated levels of an HPV-related tumor suppressor protein.

For 488 individuals with HNSCC, researchers did blood-based testing for antibodies targeting HPV16 in general, as well as testing for antibodies that target the viral proteins E6 and E7.

For a subset of patients, the team assessed the tumors themselves for the presence of HPV DNA and/or for elevated levels of the host tumor suppressor protein p16.

Based on patterns in the samples, the group determined that the presence of viral E6 and E7 proteins in the blood was linked to increased survival for individuals with an oropharyngeal form of HNSCC, which affects part of the throat known as the oropharynx.

A positive test for HPV DNA alone was not significantly linked to head and neck cancer outcomes. On the other hand, when found in combination with E6 and E7 expression, a positive HPV16 test did coincide with improved oropharyngeal cancer outcomes.

Likewise, elevated levels of p16 in a tumor were not especially informative on their own, though they did correspond to better oropharyngeal cancer survival when found together with positive blood tests for E6 and E7.

Based on these findings, Kelsey and his team concluded that “[a] stronger association of HPV presence with prognosis (assessed by all-cause survival) is observed when ‘HPV-associated’ HNSCC is defined using tumor status (HPV DNA or P16) and HPV E6/E7 serology in combination rather [than] using tumor HPV status alone.”

In a second study, meanwhile, a German group that focused on the oropharyngeal form of the disease found its own evidence arguing against the use of HPV DNA as a solo marker for HPV-associated head and neck cancer.

For that analysis, researchers assessed 199 fresh-frozen oropharyngeal squamous cell carcinoma samples, testing the tumors for HPV DNA and p16. They also considered the viral load in the tumors and looked for gene expression profiles resembling those described in cervical carcinoma — another cancer associated with HPV infection.

Again, the presence of HPV DNA appeared to be a poor indicator of HPV-associated cancers or predictor of cancer outcomes. Whereas nearly half of the tumors tested positive for HPV16 DNA, just 16 percent and 20 percent had high viral loads and cervical cancer-like expression profiles, respectively.

The researchers found that a subset of HPV DNA-positive tumors with high viral load or HPV-associated expression patterns belonged to individuals with better outcomes. In particular, they found that cervical cancer-like expression profiles in oropharyngeal tumors coincided with the most favorable outcomes, while high viral load in the tumors came a close second.

“We showed that high viral load and a cancer-specific pattern of viral gene expression are most suited to identify patients with HPV-driven tumors among patients with oropharyngeal cancer,” Dana Holzinger, that study’s corresponding author, said in a statement.

“Once standardized assays for these markers, applicable in routine clinical laboratories, are established, they will allow precise identification of patients with oropharyngeal cancer with or without HPV-driven cancers and, thus, will influence prognosis and potentially treatment decisions,” added Holzinger, who is affiliated with the German Cancer Research Center and Heidelberg University.

In a commentary article online today in Cancer Research, Eduardo Méndez, a head and neck surgery specialist with the University of Washington and Fred Hutchinson Cancer Research Centerdiscussed the significance of the two studies and their potential impact on oropharyngeal squamous cell carcinoma prognoses and treatment.

But he also cautioned that more research is needed to understand whether the patterns described in the new studies hold in other populations and to tease apart the prognostic importance of HPV infection in relation to additional prognostic markers.

 

 

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