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Covid-19 Antibody Cocktail to Begin Clinical Trial

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, in orange, emerging from cells (NIAID, Flickr)

11 June 2020. A combination of two synthetic antibodies, with an enhanced infection-blocking design for preventing and treating Covid-19 infections, is set to begin a clinical trial. Regeneron Pharmaceuticals Inc., the cocktail’s developer, also says scientific papers describing technical features and preclinical studies of the antibodies are accepted for publication in Science journals.

Regeneron Pharmaceuticals, in Tarrytown, New York, is a biotechnology company developing synthetic antibodies that invoke the immune system to prevent or treat infectious diseases. The company’s VelocImmune technology produces these human antibodies with genetically engineered mice. The engineered mice become living production lines, says the company, producing antibodies that respond as a human to a specific pathogen, while not affecting the rest of the animal. The antibodies are then retrieved and combined with human genetic characteristics for testing as therapy candidates.

For Covid-19, Regeneron uses a combination of two antibodies for neutralizing the SARS-CoV-2 virus, in a single drug code-named REGN-COV2, to both prevent or treat infections. The company says two antibodies are needed, each targeting a separate region of the characteristic protein found on the surface of the coronavirus spike, which penetrates and binds to receptor proteins in cells, beginning the infection process. Regeneron says the two antibodies in REGN-COV2 work in tandem, one antibody to start neutralizing the spike protein, with the second antibody blocking mutated forms of the virus that can form and escape after the initial attack.

Antibody cocktails have a long history in treating infectious diseases, including for HIV infections. Regeneron says its Ebola cocktail REGN-EB3, consisting of three antibodies, is under review by the Food and Drug Administration. Science & Enterprise reported in August 2019 on a clinical trial testing REGN-EB3.

“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,” says George Yancopoulos, Regeneron’s president and chief scientist in a company statement. Yancopoulos adds, “The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines.”

The clinical trial testing REGN-COV2, says the company, is an adaptive, multi-stage study enrolling patients with Covid-19 infections, both in and out of the hospital. In the trial’s early stage, the study team is looking for signs of adverse effects from REGN-COV2 as well as indicators that it generates an immune response. The second stage will test REGN-COV2 for immune response and clinical benefits among infected Covid-19 patients. Results from the first two stages will determine the size and scope of the study’s third stage.

Regeneron says two separate papers on the antibody cocktail are accepted for publication in Science journals, appearing on 15 June. One paper describes the company’s process for discovering the antibodies going into REGN-COV2, both from VelocImmune mice and former Covid-19 infection patients. The paper highlights the process for narrowing down and selecting the two antibodies that simultaneously, but separately, bind to the coronavirus spike protein.

The second paper discusses preclinical lab tests of REGN-COV2, evaluating the cocktail’s ability to block escaping mutated forms of SARS-CoV-2 viruses. The results, says Regeneron, show mutated SARS-CoV-2 forms are largely eliminated after exposure to REGN-COV2.

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