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Juno Therapeutics to Resume JCAR015 Phase II ROCKET Trial AND Acquires privately held Boston, MA-based RedoxTherapies

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 2/5/2018

Anatomy of a $9B buyout: Celgene’s quick turn from Juno’s close collaborator to new owner

 john carroll — on February 5, 2018 05:50 AM EST

https://endpts.com/anatomy-of-a-9b-buyout-celgenes-quick-turn-from-junos-close-collaborator-to-new-owner/?utm_medium=email&utm_campaign=Monday%20February%205%202018&utm_content=Monday%20February%205%202018+CID_aecea465e79bcafc58b92d3615dfacda&utm_source=ENDPOINTS%20emails&utm_term=Anatomy%20of%20a%209B%20buyout%20Celgenes%20quick%20turn%20from%20Junos%20close%20collaborator%20to%20new%20owner

 

PDATED on 11/13/2017

Juno analysis of shuttered study offers clues for CAR-T

https://www.biopharmadive.com/news/juno-analysis-of-shuttered-study-offers-clues-for-car-t/510634/

 

UPDATED on 11/28/2016

Latest deaths in Juno trial underscore the need for greater transparency in clinical trials

 

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In recent years, numerous states have passed so-called “right-to-try” laws that encourage patients to seek access to experimental drugs outside of the clinical trial framework. In addition, libertarian activists and even some individuals associated with the incoming Trump administration continue to propose moving new medicines out into widespread use after only scant safety testing. That would increase the number of patients at risk for adverse outcomes, like the ones observed in the Juno trials, before we even know whether the drugs work.

READ MORE

Right-to-try laws could curtail the development of innovative new therapies

 

The best way to identify transformative new medicines, protect patients from unexpectedly dangerous drugs, and avoid wasting health care resources is by subjecting experimental products to well-designed clinical trials that enroll sufficient numbers of patients and test relevant clinical outcomes that can then be independently reviewed by the experts at the FDA. When severe, unanticipated problems arise, the FDA needs a transparent and systematic evaluation process that can provide public insight into what happened and why. That would contribute to the progress of science and the development of the next generation of safer, better therapies.

https://www.statnews.com/2016/11/24/deaths-juno-trial-transparency-fda/

 

 

Juno Therapeutics to Resume JCAR015 Phase II ROCKET Trial

SEATTLE–(BUSINESS WIRE)–Jul. 12, 2016– Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today announced that the U.S. Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 (known as the “ROCKET” trial) in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).

Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.

 

SOURCE

http://ir.junotherapeutics.com/phoenix.zhtml?c=253828&p=irol-newsArticle&ID=2184987

 

 

Juno buys early-stage biotech for access to immuno-oncology candidate

Jul 14 2016, 16:32 ET | About: Juno Therapeutics (JUNO) | By: Douglas W. House, SA News Editor

 

Juno Therapeutics (NASDAQ:JUNO) acquires privately held Boston, MA-based RedoxTherapies. Juno’s primary aim of the deal was to secure an exclusive license to vipadenant, a small molecule adenosine A2a receptor antagonist that may disrupt key immunosuppressive pathways in the tumor microenvironment in certain cancers.

Redox licensed vipadenant from London-based Vernalis in October 2014. It was under development for the treatment of Parkinson’s disease by Biogen (NASDAQ:BIIB) but safety concerns scuppered the effort in 2010 despite encouraging efficacy in mid-stage studies. Biogen returned the rights to Vernalis in 2011.

Under the terms of the transaction, Juno will pay $10M in upfront cash plus undisclosed milestones.

SOURCE

http://seekingalpha.com/news/3193337-juno-buys-early-stage-biotech-access-immuno-oncology-candidate?source=email_rt_mc_readmore&app=1&uprof=46#email_link

 

Other related articles published in this open Access Online Scientific Journal include the following:

What does this mean for Immunotherapy? FDA put a temporary hold on Juno’s JCAR015, Three Death of Celebral Edema in CAR-T Clinical Trial and Kite Pharma announced Phase II portion of its CAR-T ZUMA-1 trial

Reporters and Curators: Stephen J Williams, PhD and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/07/09/what-does-this-mean-for-immunotherapy-fda-put-a-temporary-hold-on-jcar015-three-death-of-celebral-edema-in-car-t-clinical-trial-and-kite-pharma-announced-phase-ii-portion-of-its-car-t-zuma-1-trial/