Busting a logjam of inadequate data sharing methods and communications between pharmas and health authorities around the world is the impetus behind the creation of Accumulus Synergy Inc. The nonprofit corporation’s cloud-based platform is designed to make the regulatory process easier for everyone involved. The coalition’s initial membership is a Who’s Who of big pharma, including Amgen Inc., Astellas Pharma Inc., Bristol Myers Squibb Co., Glaxosmithkline plc, the Janssen Pharmaceutical Cos. of Johnson & Johnson, Eli Lilly and Co., Pfizer Inc., Roche Holding AG, Sanofi SA and Takeda Pharmaceutical Co. Ltd. Health care authorities it plans to collaborate with include the FDA, the EMA and the U.K. Medicines and Healthcare products Regulatory Agency.
GSK discontinues phase II trial of Immutep’s anti-LAG3 immunotherapy in ulcerative colitis
PERTH, Australia – Sydney-based Immutep Ltd. announced that partner Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 (LAG-3) cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010. GSK stopped the trial based on an assessment of clinical trial data during an interim analysis by the data review committee. GSK is conducting further analysis of the efficacy and safety data, Immutep said, and will determine next steps for the development of GSK-2831781.
Biomarin findings in hemophilia A provide fodder for hope, debate
Top-line, late-stage results with Biomarin Pharmaceutical Inc.’s gene therapy, valoctocogene roxaparvovec – also known as valrox, now commonly called Roctavian – for hemophilia A proved pleasing, though uncertainty about the compound’s fate persists. Enrolling 134 subjects, GENEr8 represents the largest phase III effort ever with a gene therapy targeting severe hemophilia A in adults. Just ahead of Roctavian’s PDUFA date last summer, the FDA surprised Biomarin with a complete response letter asking for more data. The move likely pushed back approval by about two years.
Clinical, regulatory data surged in 2020; approvals on target with pre-pandemic years
Clinical and regulatory data reported in 2020 are up 24% and 47%, respectively, over the prior year, proving to be the busiest 12 months on record for the biopharma industry, in spite of, or perhaps because of, a deadly global pandemic.
Aging immunometabolic dysfunction plays role in brain decline
Aging is not just wear and tear. It is an active process that is driven, at least in part, by chronic inflammation that is the result of immune cell dysfunction. Now, investigators at Stanford University have identified the metabolic switch underlying immune cell switch from function to dysfunction. Furthermore, by reversing metabolic dysfunction in myeloid cells, they were able to restore the learning ability of aged mice to more youthful levels.
Oncohost nabs $8M series B round for AI-powered precision oncology platform
New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S. Ourcrowd, an investment platform that simplifies investment by accredited investors and others in startups, early-stage companies and venture funds, led the round. Other participants included a group of family offices and private investors.
Also in the news
Amarin, Biocryst, Continuus, Eli Lilly, Evgen, GC, Helsinn, Humanigen, Immutep, Incyte, Innocan, Inovio, Microba, Nanoform, Neurobo, Oncosec Medical, Ono, Passage, Pfizer, Phio, Precigen, Predictive Oncology, Prevail, Sartorius Stedim, Seelos, Senhwa, Vaxess Technologies, Viiv