Clinical Hold Lifted on Covid Antibody Cocktail

FDA has lifted a clinical hold on an Immunome IND for its antibody cocktail (IMM-BCP-01) for treating Covid-19. The company says in a 3/30 quarterly financial report that is continuing clinical preparations ahead of a planned Phase 1b trial. The agency’s clinical hold precipitated a request for further information related to the preparation and administration of IMM-BCP-01 at clinical sites. In response, Immunome says it provided a comprehensive report detailing the necessary information.

IMM-BCP-01 is described as a three-antibody cocktail targeting non-overlapping regions of the Covid-19 spike protein, “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,” according to the company.