Adagene(US:ADAG) Newsfilter·2025-01-27 12:00Core Insights - Adagene Inc. announced updated clinical data for ADG126, an anti-CTLA-4 SAFEbody, showing a 33% overall response rate in microsatellite stable colorectal cancer when combined with pembrolizumab [1][2][4] Group 1: Clinical Data and Efficacy - The Phase 1b/2 trial demonstrated four confirmed partial responses out of twelve patients with a 20 mg/kg loading dose followed by 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab [1][3] - The previous data at a 10 mg/kg Q3W dose showed an overall response rate of 23%, indicating an improvement in efficacy with the new dosing regimen [3] - All responders remain on treatment at a maintenance dose of either 10 mg/kg Q3W or 10 mg/kg every six weeks (Q6W) in combination with pembrolizumab [3] Group 2: Safety Profile - No Grade 4 or 5 treatment-related adverse events were observed, with pruritus being the most common treatment-related adverse event at 25% [4] - Higher Grade 2/3 treatment-related adverse events were managed through dose modifications, resulting in no treatment discontinuations to date [4] Group 3: Technology and Innovation - ADG126 utilizes a masking technology that enhances intra-tumoral accumulation and maintains optimal plasma concentration, positioning it as a potential best-in-class CTLA-4 inhibitor [3][6] - The SAFEbody technology aims to address safety and tolerability challenges associated with antibody therapeutics by enabling tumor-specific targeting while minimizing off-tumor toxicity [6][7] Group 4: Future Plans - Due to the enhanced therapeutic index of ADG126, the company plans to evaluate a broader patient population, including those with liver metastases, in the dose expansion cohort [3]