Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has been awarded a $450-million contract from the US government to manufacture and supply REGN-COV2, Regeneron’s investigational double antibody cocktail that is currently in two Phase II/III clinical trials for the treatment of COVID-19 and in a Phase III trial for the prevention of COVID-19 infection.

The award was part of the company’s participation in Operation Warp Speed, the US government’s initiative to accelerate vaccines and treatments for COVID-19. It was awarded by the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

Regeneron began scaling up manufacturing of REGN-COV2 at business risk in the spring of 2020, and the agreement supports continued manufacturing so that the product could be made available in the US if clinical trials are successful and if the US Food and Drug Administration (FDA) grants emergency use authorization (EUA) or product approval.

The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020 as well as fill–finish and storage activities. The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will help establish the exact number of potential treatment doses (estimated range of 70,000 to 300,000) or prevention doses (estimated range of 420,000 to 1,300,000) available from these lots in total. The company says initial doses may be ready as early as the end of this summer (summer 2020). If EUA or product approval is granted, the government has committed to making doses from these lots available to the US at no cost and would be responsible for their distribution.

Regeneron has initiated late-stage clinical trials evaluating REGN-COV2 in preventing infection among uninfected people who have had close exposure to a COVID-19 patient. The trial is being run jointly with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. REGN-COV2 has also moved into the Phase II/III portion of two adaptive Phase I/II/III trials testing the cocktail’s ability to treat hospitalized and non-hospitalized patients with COVID-19.

The Phase III prevention trial is being conducted at approximately 100 sites, and the company says it expects to enroll 2,000 patients in the US. The trial will assess SARS-CoV-2, the virus that causes COVID-19, infection status.

The two Phase II/III treatment trials in hospitalized and non-hospitalized patients are planned to be conducted at approximately 150 sites in the US, Brazil, Mexico, and Chile and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer (summer 2020). Regeneron says all trials are adaptively-designed, and the ultimate numbers of patients enrolled will depend on trial progress and insights from Phase II studies.

Source: Regeneron (contract) and Regeneron (Phase III trial)