Adagene Announces First Patient Dosed in Randomized Dose Optimization Cohort of the Phase 2 Study of Muzastotug (ADG126) in Combination with KEYTRUDA® (pembrolizumab) in Microsatellite Stable Colorectal Cancer

Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA

Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm

Company anticipates trial completion in early 2027, and potential updates in 2026

Additional updates from the ongoing Phase 1b/2 trial with muzastotug, previously reported at ASCO 2025, are anticipated in the coming months

Excerpt from the Press Release:

SAN DIEGO and SUZHOU, China, Oct. 31, 2025 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the first patient has been dosed in its randomized, open label Phase 2 study of muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) in patients with microsatellite stable colorectal cancer (MSS CRC) with no liver metastases. The Phase 2 primary endpoint is overall response rate (ORR).

“We are pleased that the randomized Phase 2 trial is now underway in order to confirm the preferred dose for Phase 3 in compliance with Project Optimus,” stated Peter Luo, Ph.D., CEO and President of R&D at Adagene. “To date, muzastotug has been safely dosed at 20 mg/kg Q6W, with less than 20% Grade 3 adverse events and no discontinuations, supporting its position as the potential best in class Treg depleting anti-CTLA-4 agent with improved therapeutic window. Our approach was further highlighted by the recent 2025 Nobel Prize in physiology awarded for the seminal discovery of regulatory T cells function, consistent with the MOA of muzastotug, leveraging CTLA-4 mediated intratumoral regulatory T cell depletion strategy to treat cancer. We look forward to sharing additional data from the ongoing Phase 1b/2 to provide further evidence that muzastotug’s improved safety profile allows for higher dosing and potentially better efficacy, which has precluded the use of first-generation anti-CTLA-4 therapies in this setting.”

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