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BCG041 is a first-in-class, fully human IgG1κ bispecific antibody-drug conjugate (ADC) developed by Biocytogen. It is designed to target both B7-H3 (CD276) and the proximal membrane region of MUC1, two antigens frequently overexpressed and co-expressed in various epithelial malignancies. The ADC features a hydrophilic, protease-cleavable linker and a Topoisomerase-I inhibitor payload, designated as BCPT02, with a drug-to-antibody ratio (DAR) of approximately 8. By targeting the proximal region of MUC1, BCG041 aims to overcome common challenges associated with MUC1-targeted therapies, such as shedding and poor internalization. Preclinical data indicate that BCG041 exhibits high affinity, fast internalization, and superior antitumor efficacy in patient-derived xenograft (PDX) models of lung and breast cancer compared to monospecific ADCs. It is currently in development for a range of solid tumors, including lung, breast, gastro-esophageal, head-and-neck, colorectal, prostate, and ovarian cancers.
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