• 10 Jan 2023
• Admin
• News Article

Adagene Announces Interim Data Demonstrating Safety and Confirmed Clinical Responses of Anti-CTLA-4 SAFEbody

No dose-limiting toxicities observed when ADG126 combined up to 10 mg/kg with repeat cycles, highlighting compelling safety profile with SAFEbody precision masking technology - - Partial responses confirmed in multiple tumor types andcontinuous tumor shrinkage in cold tumors (e.g., MSS CRC) and anti-PD-1-resistant patients - - Dose expansion in combination with anti-PD-1 therapy ongoing at different dosing regimens Adagene Inc a biotechnology company committed to transforming the discovery and development of novel antibody-based immunotherapies, today announced data for its masked anti-CTLA-4 SAFEbody, ADG126, in combination with anti-PD-1 therapy in patients with advanced/metastatic solid tumors. The results (as of January 6, 2023) in 14 heavily pre-treated patients demonstrate the safety and initial efficacy profiles of ADG126 in combination with anti-PD-1 treatment. Adagene plans to present the detailed dose escalation data at an upcoming medical conference in the first half of 2023. Compelling Safety Profile in Combination with Anti-PD-1: ADG126 has been administered at escalating doses up to 10 mg/kg every three weeks in combination with a fixed dose of anti-PD-1 therapy (toripalimab = 240 mg), including repeat dosing cycles. The combination was well tolerated, with no dose-limiting toxicities observed, or maximum tolerated dose yet reached. As of January 6, 2023, an additional 10 patients are being evaluated with the combination of ADG126 and pembrolizumab in a separate clinical trial. Dose Optimization following FDA Project Optimus1 Initiative: Following completion of the dose escalation cohorts, two separate doses of ADG126 (6 mg/kg and 10 mg/kg evaluated every three or six weeks) are proceeding in expansion cohorts to address different tumor types and follow the goal of the Food and Drug Administration