EXTON, PA — Immunome, Inc. (Nasdaq: IMNM) announced a recent update regarding its Investigational New Drug (IND) submission for IMM-BCP-01, a three-antibody cocktail, for the treatment of SARS-CoV-2 (COVID-19).
The Company received a clinical hold letter from the U.S. Food and Drug Administration (FDA) 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.
“We are thankful for the rapid and insightful feedback that the FDA has provided throughout our ongoing discussions and have already initiated efforts to provide the requested information,” commented Purnanand Sarma, PhD, President & CEO of Immunome. “In addition, we remain on track to report IMM-BCP-01’s activity against the Omicron variant in live virus testing by a third-party lab in January. We remain confident in our approach to address COVID-19 and look forward to providing further updates in the coming weeks.”
This investigational work was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).
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