Therapy Areas: Infectious Diseases
Immunome Received Clinical Hold Letter from the US FDA Regarding IMM-BCP-01 for the Treatment of COVID-19
11 January 2022 - - US-based biopharmaceutical company Immunome, Inc. (NASDAQ: IMNM) has provided an update regarding its Investigational New Drug submission for IMM-BCP-01, a three-antibody cocktail, for the treatment of SARS-CoV-2 (COVID-19), the company said.

The company received a clinical hold letter from the US Food and Drug Administration in response to its recently submitted IND requesting further information related to the preparation and administration of IMM-BCP-01 at clinical sites.

The company has already initiated the requisite work and expects to provide the requested information quickly.

Unrelated, the FDA also provided in the same letter valuable guidance on the clinical protocol for IMM-BCP-01, including patient selection criteria.

This investigational work was funded by the US Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (Contract number: W911QY-20-9-0019).

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.

When tested in vivo, these mechanisms combine to significantly reduce viral load in lungs of the hamsters infected with SARS-CoV-2, and broadly neutralize the Delta (B.1.617.2) variant in vitro, with testing against the Omicron variant ongoing. Immunome has submitted an Investigational New Drug Application with the FDA and plans to initiate a placebo-controlled dose escalation study of IMM-BCP-01 in patients infected with SARS-CoV-2, pending the FDA's acceptance of Immunome's IND submission.

This investigational work was funded by the US Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency. (Contract number: W911QY-20-9-0019).

Immunome is a biopharmaceutical company that utilizes its proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics that are designed to change the way diseases are treated.

The company's initial focus is developing therapeutics to treat oncology and infectious diseases, including COVID-19. Immunome's proprietary discovery engine identifies novel therapeutic antibodies and their targets by leveraging the highly educated components of the immune system, memory B cells, from patients whose bodies have learned to fight off their disease.
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