Adagene Announces Investigator Initiated Phase 2 Trial for Neoadjuvant Muzastotug (ADG126) in Colorectal Cancer

Core Insights - Adagene Inc. announced a Phase 2 neoadjuvant trial of ADG126 for stage II or III colorectal cancer, with patient enrollment expected to begin in April 2025 and primary completion anticipated by mid-2027 [1][2] Group 1: Trial Details - The trial, led by Dr. Yong Wei Peng, will evaluate the efficacy of ADG126 in combination with KEYTRUDA, focusing on the rate of Major Pathologic Response (MPR) as the primary endpoint [2][3] - Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability, with the study also exploring pharmacodynamic effects on the tumor microenvironment [2][3] Group 2: Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4][5] - The company has established strategic collaborations leveraging its SAFEbody precision masking technology to address unmet patient needs in cancer treatment [4][5] Group 3: Technology and Pipeline - Adagene's lead clinical program, ADG126, is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies for Metastatic Microsatellite-stable Colorectal Cancer [6] - The SAFEbody platform aims to enhance safety and tolerability of antibody therapeutics by enabling tumor-specific targeting while minimizing off-tumor toxicity [5][6]