Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, ...

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. has received FDA feedback on its clinical development plan for ADG126 in combination with Merck's KEYTRUDA for treating microsatellite stable colorectal cancer [2][4] - The company plans to begin patient enrollment for Phase 2 trials in the second half of 2025 [1] Company Overview - Adagene is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using its SAFEbody technology [7][10] - The company's lead program, ADG126, is designed to target regulatory T cells in the tumor microenvironment [10] Clinical Development - ADG126 is currently in Phase 1b/2 clinical studies, with over 150 patients enrolled to date [3][10] - The Phase 2 trial will randomize patients to receive either 10 mg/kg or 20 mg/kg of ADG126 in combination with pembrolizumab, without cycle limitations [7] - The primary endpoint for the Phase 2 trial is overall response rate (ORR), with secondary endpoints including duration of response (DOR), progression-free survival (PFS), and overall survival (OS) [7] FDA Interaction - The FDA has endorsed the exploration of ADG126 at doses significantly higher than other anti-CTLA-4 antibodies, showing a nearly two-fold increase in ORR from 17% at 10 mg/kg to 29% at 20 mg/kg [5][6] - The FDA has agreed with the proposed standard-of-care control arm for the Phase 3 trial, confirming that an ADG126 monotherapy arm is not required [7] Future Directions - The company aims to identify a single optimized dose for the Phase 3 trial, which is a critical step towards obtaining FDA approval [6][7] - Future trials will focus on late-line patients with MSS CRC without liver metastases [7]

Core Insights - Sanofi has made a strategic investment of up to US$25 million in Adagene to support the development of novel antibody-based therapies, particularly focusing on the clinical development of muzastotug (ADG126) for colorectal cancer [3][6] - Adagene will provide Sanofi with muzastotug for a phase 1/2 clinical trial involving over 100 patients to evaluate its safety and efficacy in combination with other anticancer therapies [4][6] - The partnership includes the exercise of an option for a third SAFEbody discovery program, which will utilize Adagene's proprietary technology [5][6] Financial Overview - The proceeds from Sanofi's investment, along with Adagene's existing cash and cash equivalents of US$85.2 million as of December 31, 2024, are expected to fund operations into 2027 [6] Clinical Development - Adagene's lead clinical program, ADG126, is currently in phase 1b/2 studies, targeting metastatic microsatellite-stable colorectal cancer [10] - The SAFEbody technology aims to enhance safety and tolerability in antibody therapeutics by using precision masking to minimize off-target toxicity [9][10] Strategic Collaboration - A representative from Sanofi will join Adagene's Scientific Advisory Board to provide strategic advice on scientific and clinical aspects [7] - The collaboration reinforces the shared vision of advancing ADG126's potential in treating advanced solid tumors [6]