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BR116 is a bispecific antibody-drug conjugate (ADC) developed by BioRay Pharmaceutical (also known as Bioray Laboratories) that targets Cadherin-17 (CDH17) for the treatment of gastrointestinal cancers. The drug consists of a humanized bispecific monoclonal antibody conjugated to a cytotoxic topoisomerase I inhibitor payload. It is engineered using BioRay's proprietary CysX™ conjugation platform, which utilizes a hydrophilic linker to achieve a drug-to-antibody ratio (DAR) of 4. The CysX™ platform is designed for site-specific, stable, and irreversible conjugation, intended to prevent premature payload detachment in systemic circulation and minimize off-target toxicity. Preclinical data presented at the 2025 AACR Annual Meeting demonstrated significant antitumor activity in both in vitro and in vivo models, along with a favorable safety profile in non-human primates.
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