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Dual Antibodies in Trial to Prevent Covid-19 Infections

Global Covid-19

(Gerd Altmann, Pixabay)

6 July 2020. A cocktail of two synthetic antibodies will soon be tested in a clinical trial to prevent against Covid-19 infections, while also in a trial as a treatment for the disease. The new trial of the dual-antibody cocktail, made by biotechnology company Regeneron Pharmaceuticals Inc. in Tarrytown, New York, is co-sponsored by National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health.

Regeneron Pharmaceuticals develops synthetic antibodies that invoke the immune system to prevent or treat infectious diseases. The company’s 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.

As reported last month in Science & Enterprise, Regeneron is testing REGN-COV2 in 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.

The company reports the trial’s early stage, looking for signs of adverse effects, enrolled 30 Covid-19 patients, both hospitalized and ambulatory or non-hospitalized individuals. Regeneron says results show, and an independent monitoring committee concurs, REGN-COV2 is safe to continue to the trial’s later stages, although detailed findings were not disclosed.

The early-stage safety results, says Regeneron, also enable the new trial to begin, testing REGN-COV2 to protect uninfected people against Covid-19 infections. The new trial is enrolling some 2,000 participants at 100 sites in the U.S. Participants are not infected with Covid-19, but are family members or others in close contact with those infected. The trial is expected to test REGN-COV2 against a placebo looking for clinical outcomes and viral status. Like the therapy trial, the protection trial uses an adaptive design, where initial results determine the scope and process for the rest of the study.

“We are running simultaneous adaptive trials,” says George Yancopoulos, Regeneron’s president and chief scientist in a company statement, “in order to move as quickly as possible to provide a potential solution to prevent and treat Covid-19 infections, even in the midst of an ongoing global pandemic.”

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