Research & Development
Immunome Inc on track to report IMM-BCP-01's activity against the Omicron variant in live virus testing
11 January 2022 -

Biopharmaceutical company Immunome Inc (Nasdaq:IMNM) reported on Monday that it had earlier filed an Investigational New Drug (IND) submission for the three-antibody cocktail IMM-BCP-01 for the treatment of SARS-CoV-2 (COVID-19).

The company received a clinical hold letter from the US Food and Drug Administration (FDA) in response to its recent IND requesting further information related to the preparation and administration of IMM-BCP-01 at clinical sites. The US FDA provided in the same letter valuable guidance on the clinical protocol for IMM-BCP-01, including patient selection criteria.

In addition, the company has submitted an Investigational New Drug Application with the US FDA and now plans to initiate a placebo-controlled dose escalation study of IMM-BCP-01 in patients with SARS-CoV-2, pending the US FDA's acceptance of IND submission.

Concurrently, the company remains on track to report IMM-BCP-01's activity against the Omicron variant in live virus testing by a third-party lab in January and look forward to providing further updates in the coming weeks, added Purnanand Sarma, PhD, president & CEO.

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 and induces natural viral clearance mechanisms that reduce viral load in lungs of the hamsters infected with SARS-CoV-2 and neutralize the Delta variant in vitro, with testing against the Omicron variant ongoing, concluded the company.

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