First Patient Dosed in Randomized Dose Optimization Cohort of Ph 2 Study of Muzastotug + KEYTRUDA in MSS-CRC

“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.”