Core 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]

Core Insights - Adagene Inc. announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with promising efficacy and safety results [1][2][3] Efficacy - ADG126 in combination with pembrolizumab achieved a 29% confirmed overall response rate (ORR) in the 20 mg/kg cohorts, while the 10 mg/kg cohorts had an ORR of 17% [1][3] - The median overall survival (OS) for the 10 mg/kg cohorts was reported at 19.4 months, with the median OS for the 20 mg/kg cohorts not yet reached [3][4] - All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks [1] Safety - The 20 mg/kg Q6W dosing regimen demonstrated fewer than 20% Grade 3 adverse events, with no treatment discontinuations [2][4] - The study indicated a significant reduction in treatment-related toxicities while maintaining a near 30% ORR [2] Study Design - A total of 67 MSS CRC patients with no liver metastases were treated with ADG126 at either 10 mg/kg or 20 mg/kg, in combination with pembrolizumab [2] - The dosing regimens included a loading dose of 20 mg/kg followed by either 10 mg/kg every three weeks or 20 mg/kg every six weeks [2] Future Plans - As data continue to mature, the company plans to discuss the dosing regimen with regulatory bodies for the next phase of clinical development [4]

Core Insights - Adagene Inc. is set to present a poster at ASCO 2025, showcasing its advancements in antibody-based therapies [1][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 [3] - The company has established strategic collaborations with global partners to enhance its SAFEbody precision masking technology [3] Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, aimed at addressing safety and tolerability issues in antibody therapeutics [4] - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing toxicity to healthy tissues [4] Clinical Programs - The lead clinical program, ADG126 (muzastotug), is an anti-CTLA-4 SAFEbody currently in phase 1b/2 studies, focusing on Metastatic Microsatellite-stable Colorectal Cancer [5] - ADG126 targets a unique epitope of CTLA-4 in regulatory T cells within the tumor microenvironment and is being studied in combination with anti-PD-1 therapy [5] Upcoming Presentation Details - The poster presentation titled "Safety and Efficacy of ADG126 (an Anti-CTLA-4 Masking Antibody) in Combination with Pembrolizumab" will take place on May 31, 2025, at ASCO 2025 [7]