Regeneron reported that subsequent to the New York-based company’s discussions with regulatory authorities, they have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for their investigational REGN-COV2 investigational antibody combination for COVID-19. This was one of the experimental therapies administered to POTUS at Walter Reed Medical Center. Under their agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and the company expects to have doses available for 300,000 patients in total within the next few months. The company received $450m from the U.S. federal government for advanced purchases and secured ongoing support from NIAID. Eli Lilly just submitted a request for an EUA for their monotherapy monoclonal antibody called LY-CoV555.
What is REGN-COV2?
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 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 Science. Preclinical studies have shown that REGN-COV2 reduced the amount of virus and associated damage in the lungs of non-human primates.
What’s the Basis for the Action?
Regeneron has been running an entire clinical trial program involving multiple studies investigating REGN-COV2. TrialSite has followed these studies closely and in fact has reported on some of the more unorthodox features of this development effort. The company recently announced that the first data from a descriptive analysis of seamless Phase 1/2/3 trial evidences the reduction of viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also reveals positive trends in reducing medical visits. The ongoing, randomized, double-blind trial measures the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care.
POTUS was recently administered the investigational drug during his hospital stay at Walter Reed Medical Center. As TrialSite reported, POTUS was more than impressed with the therapies’ potential.
REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.
Partnership with Roche
Regeneron has recently partnered with Roche to increase the global supply of REGN-COV2. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. (beyond the initial U.S. Government supply) and Roche will develop, manufacture and distribute it outside the U.S.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases. 2/3 Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune®, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics.