FDA lifts clinical hold on Immunome's SARS-CoV-2 antibody cocktail

By The Science Advisory Board staff writers

April 4, 2022 -- Biopharmaceutical company Immunome said that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its antibody cocktail for the treatment of SARS-CoV-2.

The cocktail, IMM-BCP-01, contains three monoclonal antibodies that bind to nonoverlapping regions of the spike protein with picomolar affinity. The antibodies exhibit combinatorial effects in vitro against multiple SARS-CoV-2 variants, according to the company. These include the variants that demonstrate both increased transmission in the U.S. and resistance to current antibody therapeutics and vaccines, Immunome said.

The FDA had placed Immunome's investigational new drug (IND) application on hold. In response, the company provided the FDA with a comprehensive report on IMM-BCP-0.

The company said that it plans to initiate a placebo-controlled dose escalation study of IMM-BCP-01 in patients with SARS-CoV-2.

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