FLC | BARDA partner Regeneron begins trials of COVID-19 antibody cocktail

BARDA partner Regeneron begins trials of COVID-19 antibody cocktail

June 16, 2020

One of the Biomedical Advanced Research and Development Authority's (BARDA) first private sector partners in the COVID-19 response, Regeneron, has begun the first clinical trials of REGN-COV2, its therapeutic two-antibody “cocktail” for COVID-19 patients. This treatment, developed with BARDA support, has the potential to be one of the first therapeutics specifically designed to inhibit SARS-COV-2, the virus that causes COVID-19.

The therapeutic cocktail contains two neutralizing monoclonal antibodies. Neutralizing monoclonal antibodies were initially identified from Regeneron’s proprietary genetically-humanized VelocImmune® mice and from COVID-19 convalescent patient blood, and then expanded and manufactured in large quantities. The investigational antibody cocktail may help COVID-19 patients recover from the disease more quickly, while simultaneously giving patients more time to develop their own antibodies to fight the infection. Tarrytown, New York-based Regeneron is also planning to explore REGN-COV2’s potential for preventing SARS-CoV-2 infection in people who have not yet been infected by the virus.

To address any potential mutation, a cocktail of two monoclonal antibodies that neutralize SARS-CoV-2 and bind to non-overlapping regions of the virus’s spike protein was selected. The cocktail approach reduces the chance that the virus will be able to ‘escape’ treatment and evolve into a treatment-resistant strain. With a multi-antibody approach, the virus would need multiple simultaneous mutations in multiple genetic locations to evade neutralization.

These initial Phase 1/Phase 2 clinical trials will provide the first data on the safety and efficacy of the treatment in hospitalized and non-hospitalized patient volunteers with symptomatic COVID-19. Currently, there are no FDA-approved COVID-19 treatments.