By Vicky Su
On July 7th, 2020, Regeneron Pharmaceuticals, Inc. announced that the Trump administration has awarded them a $4.5 billion contract to manufacture and supply REGN-COV2, an investigational antibody cocktail for COVID-19.
REGN-COV2 is a novel double-antibody drug cocktail developed by Regeneron. The two virus-neutralizing antibodies in the cocktail can recognize and bind to the receptor of the critical spike protein that SARS-COV-2 uses to enter cells. Similar to the cocktail therapy concept used for HIV prevention, the double-antibody could protect against viral escape and achieve antiviral effects.
In mid-June 2020, Regeneron launched the first REGN-COV2 clinical trial, aiming to test the ability to treat and prevent coronavirus. Four cohorts were recruited; hospitalized and non hospitalized symptomatic COVID-19 patients, as well as uninfected people such as healthcare workers with high exposure risk, and uninfected people exposed to COVID-19 (such as the patient’s roommates).
On July 6th, the company announced the initiation of its late-stage trials. A Phase 3 trial will evaluate REGN-COV2’s ability to prevent COVID-19, which is expected to recruit 2,000 uninfected subjects in close contact with COVID-19 patients. The trial will be conducted in 100 different locations.
REGN-COV2 has also moved to the Phase 2/3 section that evaluates the cocktail’s ability to treat hospitalized and non-hospitalized (or “ambulatory”) patients with COVID-19. The trial will recruit about 1,850 inpatients and 1,050 non-inpatients (e.g., outpatients), and conducted in approximately 150 regions in the United States, Brazil, Mexico, and Chile.
Besides, these ongoing clinical trials are also aiming to identify the most suitable dose. Regeneron is expected to release the drug by the end of the summer. The US government has promised that if the drug notches an emergency FDA authorization for both the prevention and treatment o COVID-19, it will be distributed to the people free of charge.
“This agreement with Regeneron is the first of several Operation Warp Speed awards to support potential therapeutics through large scale manufacturing, allowing faster distribution if trials are successful,” said HHS Secretary Alex Azar.
Editor: Sherry Hsiao
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