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Immunome Announces Submission of an Investigational New Drug (IND) Application for IMM-BCP-01 for the Treatment of COVID-19
- IMM-BCP-01 targets three non-overlapping regions on the Spike protein to provide broad coverage across CDC current and former variants of concern -
About this update from Immunome, Inc.
[{"type":"text","content":"\n- IMM-BCP-01 targets three non-overlapping regions on the Spike protein to provide broad coverage across CDC current and former variants of concern\n\n- IMM-BCP-01 elicits multi-modal activity in pre-clinical testing including ACE2 and non-ACE2 dependent neutralization, as well as natural viral clearance mechanisms\n\n EXTON, Pa.--(BUSINESS WIRE)--\nImmunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for IMM-BCP-01, a three-antibody cocktail, for the treatment of SARS-CoV-2 (COVID-19).\n\n“I am thrilled that Immunome has submitted its first IND, which is another milestone towards advancing IMM-BCP-01 into the clinic. We look forward to a close collaboration with clinical investigators to study this important and novel candidate for the treatment of COVID-19, especially as the pandemic continues to be a major public health issue,” said Purnanand Sarma, PhD, President & CEO of Immunome. “With the continued emergence of new variants, such as Omicron, and resurgence in SARS-CoV-2 cases despite high vaccination rates, we believe therapeutic treatment options for COVID-19 are essential. We further believe that a carefully designed cocktail, based on direct human immune response against SARS-CoV-2, could provide a novel and powerful approach to combat this virus.”\n\nIMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein and elicits multi-modal activity in pre-clinical testing, including both ACE2 and non-ACE2 dependent neutralization, as well as inducing natural viral clearance mechanisms, such as complement activation and phagocytosis. The cocktail significantly reduces viral load in lungs of the hamsters infected with SARS-CoV-2, and broadly neutralizes CDC current and former variants of concern, including the Delta variant, in in vitro testing. Immunome’s preclinical work includes investigational product safety testing. Immunome plans to initiate a placebo-controlled dose escalation study of IMM-BCP-01 in patients infected with SARS-CoV-2, pending FDA’s acceptance of Immunome’s IND submission.\n\nThis investigational work was funded by the U.S. Dep...