Regeneron Begins Human Trials of First Dual Antibody Cocktail for Prevention and Treatment of COVID-19

Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) has initiated the first clinical trial of REGN-COV2, its investigational dual antibody cocktail for the prevention and treatment of COVID-19.

Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies and have scaled them up for clinical use with the company's in-house VelociMab and manufacturing capabilities. The two antibodies bind non-competitively to the critical receptor binding domain (RBD) of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment.

The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders) and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate).

The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine size for the 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," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. "REGN-COV2 could have a major impact on public health by slowing 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."

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