The combined forces of the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense have just approved a $450M deal with Regeneron Pharmaceuticals, Inc. This $450 million contract is for Regeneron to manufacture and supply REGN-COV2. REGN-COV2 is Regeneron’s investigational double-antibody cocktail for COVID-19 treatment and prevention. Regeneron is currently in Phase 2/3 of clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19.
If clinical trials are successful, the FDA may grant Emergency Use Authorization (EUA) so this can immediately be manufactured for the US. The agreement “covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will help establish the exact number of potential treatment doses (estimated range of 70,000 to 300,000) or prevention doses (estimated range of 420,000 to 1,300,000) available from these lots in total.” according to the Regeneron press release July 7, 2020.
VelociSuite®, an antibody discovery, and development technology by Regeneron has been 30 years in the making. Their large-scale manufacturing facilities ensure that REGN-COV2 can be accessed to as many people as possible as quickly as possible and t is why the U.S. government approved this $450M deal with Regeneron.
REGN-COV2 could be available as soon as late summer, and if EUA is granted, the government has committed to making doses from the above lots available to U.S. residents for free.
Regeneron’s proprietary VelocImmune® GMO mice have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. “They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail with the company’s in-house VelociMab® and manufacturing capabilities. REGN-COV2’s two antibodies bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications. More recent research also demonstrates coverage against the now prevalent D614G variant.”
Regeneron is known for this same ‘rapid response’ method and “cocktail” approach for their “REGN-EB3”, a triple antibody treatment for Ebola (currently under FDA regulatory review)
Octavius Health keeps you in the know with industry news. Read more related articles.