This deal with BARDA and the DoD supports continuing the manufacturing in order for it to be immediately available in the U.S. if the clinical trials are successful.
Yesterday, Regeneron Pharmaceuticals, with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), announced it was launching Phase III trials of REGN-COV2, the company’s two-antibody cocktail for the treatment and prevention of COVID-19. Today, it announced that it had received a $450 million contract to manufacture and supply the antibody cocktail as part of Operation Warp Speed from the Biomedical Advanced Research and Development Authority (BARDA).
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The contract was also with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
Using its proprietary VelocImmune mice, Regeneron screened thousands of fully-human antibodies. The mice have been genetically modified to have a human immune system. They also evaluated antibodies isolated from people who have recovered from COVID-19. They then chose the two most potent, non-competing antibodies that were most effective at neutralizing SARS-CoV-2, the virus that causes COVID-19. They then scaled up the dual-antibody cocktail for clinical use with the company’s own VelociMab and manufacturing capabilities.
The two antibodies bind non-competitively to the receptor binding domain of the virus’s spike (S) protein. This decreases the ability of mutant viruses to avoid treatment and protects against spike variants that have evolved in the human population.
There are specifically two trials. A Phase III trial will study if REGN-COV2 can prevent infection in uninfected people who have had close exposure to a COVID-19 patient. The drug has also been advanced into the Phase II/III portion of two adaptive Phase I/II/III trials evaluating the cocktail in treating hospitalized and non-hospitalized patients with COVID-19.
A Phase I trial in 30 hospitalized and non-hospitalized patients with COVID-19 received a positive review from the Independent Data Monitoring Committee.
The Phase III prevention study will be run at about 100 locations and enroll about 2,000 people in the U.S. The Phase II/III treatment trials in hospitalized patients will evaluate about 1,850 hospitalized patients and 1,050 non-hospitalized patients and is planned for about 150 sites in the U.S., Brazil, Mexico, and Chile. It will study virologic and clinical endpoints. Preliminary data is expected later this summer.
The company had begun scaling up manufacturing of REGN-COV2 in the spring at its own expense. This deal with BARDA and the DoD supports continuing the manufacturing in order for it to be immediately available in the U.S. if the clinical trials are successful. That availability would be dependent on efficacy and safety and on the U.S. Food and Drug Administration (FDA)’s granting of an Emergency Use Authorization (EUA) or product approval.
The contract covers a fixed number of bulk lots expected to be manufactured by the fall of 2020 in addition to fill/finish and storage. At this time, an exact dosage amount is not able to be announced because dosages will be determined during the clinical trials. The company is estimating treatment doses manufactured between 70,000 and 300,000 and preventative dosages from 420,000 to 1,300,000, from these manufacturing lots. It is possible initial doses could be ready by the end of summer.
If approved or granted EUA, the U.S. government is committed to making the doses from these lots available to the American public at no cost. The government would also oversee distribution.
“Regeneron’s thirty years of investment in our innovative VelociSuite antibody discovery and development technologies and our large-scale manufacturing facilities, coupled with the expertise and passion of our people, has enabled us to move the REGN-COV2 program forward at remarkable speed,” said Leonard S. Schleifer, co-founder, president and chief executive officer of Regeneron. “We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic.”
