During the COVID-19 pandemic, Regeneron applied our more than 30 years of scientific and technology expertise to combat a novel and quickly mutating virus. We were uniquely positioned to face this public health threat given our proprietary VelociSuite® technologies and our track record against infectious diseases such as Ebola.
Our COVID-19-related discovery efforts started in early 2020, when we utilized VelociSuite to produce and evaluate hundreds of virus-neutralizing antibodies in our genetically engineered mice. We also identified similarly performing antibodies from human COVID-19 survivors in order to maximize the pool of potential candidates. We quickly evaluated and selected two potent, complementary antibodies that bound to different, non-overlapping parts of the spike protein of the SARS-CoV-2 virus, thereby blocking the virus’s ability to infect healthy cells.
Improving on our prior infectious disease timeline, this combination was ready to enter human clinical trials just five months after the world first learned the SARS-CoV-2 viral sequence. As part of our rapid response approach and in recognition of the tremendous global need, we simultaneously initiated clinical trials and our large-scale manufacturing process. Manufacturing biologic medicines like monoclonal antibody therapies is a time-consuming and precise process, and unfortunately biology can’t be hurried along. Despite the risks and uncertainties, we purposefully began this effort as early as possible so that we would have as many doses as possible immediately available for people around the world.
The antibody medicine combination received emergency use authorization (EUA) from the U.S. Food and Drug Administration in November of 2020, the first combination therapy to receive an EUA and in record time – only 10 months after the program's inception.
The U.S. government signed multiple agreements with Regeneron for the purchase of nearly three million doses of the investigational antibody therapy and made the medicine available for free to patients who qualified under the EUA criteria. Regeneron also collaborated with Roche to increase global supply of the medicine, with Regeneron responsible for development of the therapy in the U.S., and Roche primarily responsible for development and distribution outside the U.S. The companies made a shared commitment to making the antibody combination available to COVID-19 patients around the globe and to supporting access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
Viruses, by their nature, mutate over time leading to variant forms. Indeed, Regeneron’s antibody cocktail remained active against numerous strains of the SARS-CoV-2 virus, including Delta; however, it lost potency against the Omicron variant. In January 2022, the FDA amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment. Therefore, the antibody cocktail is not currently authorized for use in any U.S. states, territories or jurisdictions. Please refer to the authorized Fact Sheet and FDA statement for additional details.
Ongoing research in infectious diseases
Regeneron has hundreds of additional investigational, SARS-CoV-2 neutralizing antibodies in our labs, and we are evaluating next steps with these novel early-stage candidates. Regeneron’s infectious disease programs have led to an approved medicine for Ebola, an emergency use authorized medicine for COVID-19, and an investigational medicine for Middle East Respiratory Syndrome (MERS). We continue to explore new potential medicines for emerging infectious diseases and established viruses like influenza, in part through long-standing research collaborations with BARDA.