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Covid-19 Antibody Cocktail Trial Request Filed

Human B-cell

Human B-cell (NIAID, Flickr)

29 Nov. 2021. A discoverer of synthetic antibodies is asking Food and Drug Administration for clearance to begin a clinical trial of a Covid-19 antibody cocktail therapy. Immunome Inc. in Exton, Pennsylvania filed an investigational new drug application with FDA for its experimental three-antibody combination code-named IMM-BCP-01 to treat patients with SARS-Cov-2 infections.

Immunome discovers and develops synthetic antibody therapies to treat cancer and infectious diseases derived from blood samples donated by patients with those conditions. From the blood samples, the company focuses on B-cells, white blood cells in the immune system that produce antibodies in response to invading pathogens. Immunome pairs its captured B-cells with corresponding antigens in an hybridoma technology first designed for cancer immunotherapies, by screening the antibodies against its library of disease-related antigens. That screening process looks for antibodies from memory B cells, those providing for long-term adaptive immunity, with high affinity for their antigen targets.

The result, says Immunome, is highly targeted monoclonal antibodies designed to produce immune responses to treat cancer or infectious diseases. The company says its IMM-BCP-01 therapy for Covid-19 infections is a cocktail of three antibodies each addressing separate regions of the protein on the surface of the SARS-CoV-2 viral spikes. Immunome says the antibody targets include areas of the spike-surface protein binding to angiotensin-converting enzyme 2 or ACE2 receptors in cells, and other spike protein chemistry components.

Test against a placebo and with increasing doses

Immunome says in preclinical studies, IMM-BCP-01 reduces viral loads in lungs of hamsters, and neutralizes all variants of concern at the time, including the Delta variant. The company says its preclinical work on IMM-BCP-01 is funded by a contract from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in the U.S. Department of Defense.

“With the continued emergence of new variants, such as Omicron,” says Purnanand Sarma, president and CEO of Immunome, in a company statement, “and resurgence in SARS-CoV-2 cases despite high vaccination rates, we believe therapeutic treatment options for Covid-19 are essential. We further believe that a carefully designed cocktail, based on direct human immune response against SARS-CoV-2, could provide a novel and powerful approach to combat this virus.”

Pending acceptance of the company’s investigation new drug application or IND, Immunome plans a clinical trial of IMM-BCP-01 with Covid-19 infected patients, testing the treatment against a placebo and with increasing doses. An investigational new drug application officially seeks permission from FDA to ship new drug candidates across state lines to clinical trial sites, in effect requesting permission for a clinical trial.

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