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This investigational combination therapy, developed by BioNTech SE in collaboration with Genmab and Bristol Myers Squibb, is designed for the treatment of microsatellite stable or mismatch repair proficient (MSS/pMMR) metastatic colorectal cancer (mCRC). The regimen consists of two bispecific antibodies and standard chemotherapy. BNT314 (GEN1059) is a DuoBody-based bispecific antibody targeting EpCAM and the co-stimulatory receptor 4-1BB (CD137), intended to activate T cells within the tumor microenvironment. BNT327 (pumitamig) is a bispecific antibody targeting PD-L1 and VEGF-A, combining immune checkpoint blockade with anti-angiogenic activity. These biologics are administered intravenously alongside standard chemotherapy regimens such as FOLFIRI, mFOLFOX6, or CAPEOX. The combination is currently being evaluated in a Phase 1/2 clinical trial (NCT07079631) to overcome the typical immunotherapy resistance observed in MSS/pMMR colorectal tumors.
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