Drug intelligence / Profile preview

BR116

Development stage
Preclinical
Lead developer
BioRay Pharmaceutical
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

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.

02

Targets

CDH17 (Cadherin-17)TOP1 (DNA Topoisomerase I)

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