Adagene(US:ADAG) Globenewswire·2025-10-31 11:00Core Insights - Adagene Inc. has initiated a Phase 2 clinical trial for muzastotug in combination with KEYTRUDA for patients with microsatellite stable colorectal cancer, with the first patient dosed in October 2025 [1][2] - The trial aims to confirm the optimal dosing for a subsequent Phase 3 trial, with completion anticipated in early 2027 and potential updates expected in 2026 [1][2] Phase 2 Clinical Trial Details - The trial will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug, with up to 30 patients per arm [1][4] - The primary endpoint is overall response rate (ORR), while secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS) [4] Phase 1b/2 Trial Findings - In the Phase 1b/2 trial, 67 patients were treated with muzastotug, showing an ORR of 17% for the 10 mg/kg cohort and 29% for the 20 mg/kg cohort [3][4] - The median duration of response for the 10 mg/kg cohort was 6.2 months, while the median overall survival for the 10 mg/kg cohort was 19.4 months [5] Safety Profile - Muzastotug has been safely dosed at 20 mg/kg with less than 20% Grade 3 adverse events and no discontinuations, indicating a favorable safety profile compared to first-generation anti-CTLA-4 therapies [2][5] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [7][8] - The company's lead program, ADG126 (muzastotug), targets regulatory T cells in the tumor microenvironment and is part of a broader pipeline leveraging its SAFEbody technology [9]