ADAG News & Events

2026 Objectives: Q1 2026: Data update from the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in 3L+ MSS CRC, including 41 patients in the 10 mg/kg cohorts and 26 patients in the 20 mg/kg cohorts. Complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, which is being conducted in alignment with FDA Project Optimus, and designed to allow dose regimen selection for Phase 3. Provide preliminary clinical data, including pathological responses, to inform future development from investigator-initiated Phase 2 trial for neoadjuvant muzastotug + pembrolizumab in colorectal cancer. Provide initial clinical data from a new cohort of patients in the ongoing Phase 1b/2 study of muzastotug + pembrolizumab in combination with standard of care in MSS CRC patients. Share results of the clinical trial collaboration with Roche, which evaluates muzastotug in triplet combination with atezolizumab and bevacizumab in first-line treatment of locally advanced or metastatic hepatocellular carcinoma.

Adagene (ADAG) announced that the U.S. Food and Drug Administration, FDA, has designated muzastotug, in combination with Merck's (MRK) anti-PD-1 therapy, KEYTRUDA, as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer, MSS mCRC, without current or active liver metastases. Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody engineered to overcome CTLA-4-mediated Treg resistance in tumors with enhanced safety and efficacy, delivering a therapeutic index beyond the reach of existing CTLA-4 therapies.