ADAG · Adagene Inc.

Adagene's filing contains two significant investor updates. First, the company announced a strategic clinical collaboration with Incyte to evaluate its lead asset, muzastotug (ADG126), in combination with Incyte's TGFβR2 × PD-1 bispecific antibody, INCA33890, for patients with microsatellite stable colorectal cancer (MSS CRC). This collaboration, where Incyte will sponsor and conduct the study while Adagene provides clinical supply of muzastotug, represents additional validation of Adagene's SAFEbody technology platform and positions muzastotug as a potential backbone therapy for next-generation immuno-oncology combinations. The study targets a patient population (MSS CRC with or without liver metastases) that has historically been resistant to current immunotherapies, addressing a significant unmet medical need. Second, the filing presents compelling updated clinical data from the Phase 1b/2 study of muzastotug in combination with pembrolizumab in late-line MSS CRC patients without liver metastases. The data demonstrates clear dose-dependent efficacy improvements at the 20 mg/kg dose level, with confirmed overall response rate doubling from 13% to 31%, median progression-free survival increasing from 4.8 to 6.7 months, and favorable overall survival trends. Importantly, the safety profile remains differentiated with no dose-limiting toxicities, no Grade 4/5 treatment-related adverse events, and low discontinuation rates, supporting the therapeutic window expansion claimed for the SAFEbody platform. The company has incorporated these findings into its ongoing randomized Phase 2 trial design, with results expected in the first half of 2027, potentially paving the way for a registration study. The FDA Fast Track designation for this combination further underscores its potential regulatory pathway. Together, these developments strengthen the clinical validation of Adagene's platform and lead asset while expanding its partnership network in the competitive immuno-oncology space.