Developing 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 treat people with COVID-19 and to prevent SARS-CoV-2 infection.

REGN-COV2 is currently being studied in four late-stage clinical trials: two Phase 2/3 trials for the treatment of hospitalized and non-hospitalized (“ambulatory”) COVID-19 patients, the open-label, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient (such as the patient’s housemate). The Phase 3 prevention trial is being jointly conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The safety of REGN-COV2 is also being evaluated in a Phase 1 healthy volunteer study.

Clinical investigators, hospitals or clinical sites interested in joining the REGN-COV2 clinical trials can email us at [email protected]. If you are interested in participating in one of our COVID-19 clinical trials, please complete a brief online screener at ClinLife.com/COVID to see if you qualify.

Our COVID-19-related discovery efforts started in early 2020, when we produced hundreds of virus-neutralizing antibodies in our genetically-engineered mice and identified similarly-performing antibodies from human COVID-19 survivors. In April, we moved the two most potent antibodies into cell production lines, in preparation for clinical study and large-scale availability, and clinical trials began in June.

Read more about the clinical program here

We are actively working to maximize production capacity of REGN-COV2 and ensure it reaches as many people as possible in the United States and around the world, should ongoing clinical trials be successful and regulatory approvals are granted.

We are collaborating with Roche to significantly increase the global supply of REGN-COV2, with both companies dedicating a certain manufacturing capacity to REGN-COV2 each year. This is expected to increase existing capacity by at least three and a half times, with the potential for even further expansion. If approved, Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.

We are also manufacturing and providing REGN-COV2 to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense. Read more about our manufacturing and supply agreements HERE and HERE.