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1. Executive Summary
IMM-BCP-01 is an investigational therapeutic antibody cocktail developed by Immunome, Inc., designed for the potential treatment or prevention of COVID-19. Derived from the memory B cells of convalescent COVID-19 patients, IMM-BCP-01 comprises three distinct human monoclonal antibodies: IMM20184, IMM20190, and IMM20253.[1] These antibodies target three non-overlapping, conserved epitopes on the SARS-CoV-2 Spike (S) protein, employing a multi-modal mechanism of action.[2] Two antibodies directly block the S protein's interaction with the human ACE2 receptor, while the third binds a cryptic epitope, inducing conformational changes and dissociation of the S protein trimer.[1] Furthermore, the cocktail potently engages Fc-mediated effector functions, including antibody-dependent cellular cytotoxicity (ADCC), phagocytosis, and complement activation.[1] Preclinical studies demonstrated broad in vitro neutralization activity against numerous SARS-CoV-2 variants of concern (VoCs), including Alpha, Beta, Delta, and Omicron (BA.1 and BA.2), alongside significant in vivo efficacy in reducing lung viral titers in hamster models.[1] A Phase 1b clinical trial (NCT05429021) was initiated in June 2022 to evaluate safety, pharmacokinetics, and viral clearance in patients with mild-to-moderate COVID-19.[5] The first dosing cohort was completed without significant safety issues.[7] However, in March 2023, Immunome announced its decision to deprioritize the program and seek a partner for further development, citing a strategic shift towards oncology following a major collaboration agreement.[1] As such, the future clinical advancement of IMM-BCP-01 remains uncertain.
2. Introduction
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