Adagene Inc. (NASDAQ: ADAG), a biopharmaceutical company dedicated to the discovery and development of innovative antibody-based therapies, has announced updated results from the Phase Ib/II study of its anti-CTLA-4 SAFEbody, ADG126 (Muzastotug), in combination with pembrolizumab for the treatment of advanced/metastatic microsatellite stable colorectal cancer (MSS CRC) at the 2024 European Society of Medical Oncology (ESMO) Congress. The study, known as TranStar102, demonstrated a favorable overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS), along with early survival benefits for patients with MSS CRC.
The data revealed that among patients with known CLDN18.2 and PD-L1 status, the median PFS was 14.2 months for those with H/M CLDN18.2 expression, with a confirmed ORR of 68%. Notably, the vast majority of these patients had PD-L1 CPS<5. The 12-month overall survival rate for the entire population was 73.8%, indicating the potential of ADG126 in improving outcomes for patients with MSS CRC.
ADG126 is a high-affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced ADCC, which has been granted Orphan Drug Designation in the U.S. for the treatment of patients with G/GEJ and pancreatic cancer. The drug’s unique epitope targeting and lack of Fc end optimization result in stronger ADCC and extremely low immunogenicity, with minimal impact on pharmacokinetic characteristics. -Fineline Info & Tech
