Regeneron Pharmaceuticals Inc. posted positive initial results from its ongoing phase III study of its monoclonal antibody cocktail, REGEN-COV (casirivimab and imdevimab), used as a passive vaccine, designed to provide immediate short-term passive immunity to prevent COVID-19 in people at high risk of infection due to household exposure to a COVID-19 patient. Eli Lilly and Co. reported upbeat news the same day, as the phase III Blaze-1 trial testing its antibody cocktail met its primary and key secondary endpoints.
Merck & Co. Inc. dropped a bombshell Jan. 25, announcing that it was terminating its two COVID-19 vaccine programs, V-590 and V-591, because neither demonstrated convincing levels of efficacy in phase I trials. As a relatively late entrant to the COVID-19 vaccine race, Merck, of Kenilworth, N.J., was never a leading contender in the effort to bring safe and efficacious vaccines to market. Even so, the failure of these programs is a significant setback, given the company’s scale and experience as a global vaccine manufacturer.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Antios, Astrazeneca, Durect, Dynavax, Exelixis, Genentech, Macrogenics, Medigen, Synairgen, Zydus.
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.
At the recent 39th J.P. Morgan Healthcare Conference, Biomarin Pharmaceutical Inc. popped the lid off top-line results from its ongoing phase III GENEr8-1 study with valoctocogene roxaparvovec – also known as valrox, now commonly called Roctavian. Data, though encouraging, may not have quelled controversy around the prospect.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Birchbiomed, Immutep, Nanoform, Regeneron, Sanofi, Senhwa, Windtree.
Antibody development for treating COVID-19 continues producing positive results, the latest being from Eli Lilly and Co.’s bamlanivimab (LY-CoV-555), which reduced nursing home residents’ risk of contracting symptomatic COVID-19 by 80%, according to new data from its phase III Blaze-2 study.
With worrisome COVID-19 variants cropping up, developers including the likes of Gritstone Oncology Inc. and Vir Biotechnology Inc. continue their efforts to invent new vaccines that may get around the drawbacks of existing shots if they turn up.
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