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Regeneron launches clinical trial of COVID-19 antibody ‘cocktail’

By Sean Whooley | June 11, 2020

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that it initiated the first clinical trial of its dual antibody cocktail for preventing COVID-19.

The REGN-COV2 clinical program will include populations of hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that have a high risk of exposure (healthcare workers or first responders, for example) and uninfected people with close exposure to a COVID-19 patient (such as a housemate). The placebo-controlled trials will be conducted at multiple sites, according to a news release.

Using its proprietary genetically modified VelocImmune mice, which have a human immune system and antibodies isolated from humans who recovered from COVID-19, Regeneron scientists evaluated thousands of fully human antibodies. They then selected the two most potent, non-competing and virus-neutralizing antibodies and scaled them up for clinical use. The antibodies bind non-competitively to the critical receptor-binding domain of the virus’ spike protein, which diminishes the ability of mutant viruses to escape treatment.

Tarrytown, N.Y.-based Regeneron used the same “rapid response” approach to develop its REGN-EB3 antibody treatment for Ebola that is under review by the FDA. Its first two adaptive Phase 1 and 2 studies for the COVID-19 cocktail evaluate virologic and safety endpoints and virologic and clinical endpoints, respectively. Data from both studies will be used to refine endpoints and determine the size for Phase 3 studies.

“We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral ‘escape,’ a critical precaution in the midst of an ongoing global pandemic,” Regeneron co-founder, president & chief scientific officer Dr. George Yancopoulos said in the news release. “REGN-COV2 could have a major impact on public health by slowing the spread of the virus and providing a needed treatment for those already sick – and could be available much sooner than a vaccine. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines.

“Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches.”


Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease
Tagged With: coronavirus, covid-19, Regeneron
 

About The Author

Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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