The Next Big Thing in COVID-19 Treatment: Here Come the Biologics!
The first "biologic" type drug derived from COVID-19 human convalescent antibodies, Tarrytown-based Regeneron's REGN-COV2 will begin human trials in the New York area soon. In this video Bronx virologist Kartik Chandran, Ph.D. describes the potential of monoclonal antibodies such as those in REGN-COV2.
A Novel Anti-Viral Antibody Cocktail
We are using our end-to-end antibody technologies to develop REGN-COV2, our novel anti-viral antibody cocktail that is being studied for its potential both to prevent infection and treat people already infected with SARS-CoV-2.
Clinical trials of REGN-COV2 began in mid-June. The clinical program consists of four separate study populations: two for treatment and two for prevention of COVID-19. The first studies are evaluating safety and efficacy in hospitalized and non-hospitalized patients with COVID-19.
Clinical investigators, hospitals or clinical sites interested in joining the REGN-COV2 clinical trials should email COVID19SiteInterest@regeneron.com.
Our COVID-19-related discovery efforts started in early 2020, when we produced hundreds of virus-neutralizing antibodies in our genetically-engineered mice and isolated similarly-performing antibodies from human COVID-19 survivors. In mid-April, we moved the most potent antibodies into pre-clinical and clinical-scale cell production lines. We are scaling production to have hundreds of thousands of preventative doses or tens of thousands of treatment doses per month by the end of August. We are actively seeking ways to maximize production capacity within Regeneron and beyond.
Two manuscripts published in Science detail the discovery of REGN-COV2 and highlight its potential to protect against ‘viral escape’ of SARS-CoV-2. Viral escape was seen to occur in the setting of a single therapeutic antibody that blocks the ability of a virus to infect healthy cells, spontaneously arising mutant forms of the virus are able to ‘escape’ or evade the antibody’s blocking action. These mutants are then ‘selected’ (i.e., are able to survive and proliferate despite the single antibody treatment) and may ultimately become the dominant strain of the virus. The findings show our antibody cocktail may be able to diminish risk of viral escape by binding to the virus’s spike protein in separate, non-overlapping locations, requiring the virus to mutate simultaneously in multiple genetic locations.
From discovery to large-scale manufacturing, our VelociSuite® technologies provide unmatched precision and speed in developing targeted antibody medicines.
For an overview of how anti-viral antibody medicines and vaccines are similar and different, download this PDF.