Anti-SARS-CoV-2 Antibody Cocktail Heads Towards Clinic

Pennsylvania-based Immunome, Inc. recently announced that the U.S. FDA lifted the clinical hold on its Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) for the treatment of SARS-CoV-2 (COVID-19).

Immunome stated in a press release issued on March 11, 2022, the FDA previously placed the company’s IND application on clinical hold due to a request for further information related to the preparation and administration of IMM-BCP-01.

In response, Immunome provided the FDA with a comprehensive report detailing the necessary information.

And plans to initiate a placebo-controlled dose-escalation study of IMM-BCP-01 in patients infected with the SARS-CoV-2 coronavirus.

“We believe in the potential of IMM-BCP-01 and its ability to aid in the ongoing fight against SARS-CoV-2, especially as the new variants continue,” commented Purnanand Sarma, Ph.D., President & CEO of Immunome.

“We are pleased to report the clinical hold has now been lifted, and we look forward to advancing the program into the clinic.”

IMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein of SARS-CoV-2, including highly conserved, subdominant epitopes, which elicits both ACE2 and non-ACE2 dependent neutralization and induces natural viral clearance mechanisms, such as antibody-dependent cellular cytotoxicity, complement activation, and phagocytosis.

This investigational work was funded by the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense in collaboration with the Defense Health Agency.

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Note: This press release was edited for clarity and curated for mobile readers.