Adagene Inc. (NASDAQ: ADAG) announced a clinical collaboration with Incyte (NASDAQ: INCY) to evaluate a combination therapy for patients with microsatellite stable colorectal cancer. The partnership will test Adagene's muzastotug (ADG126) with Incyte's INCA33890, a bispecific antibody targeting TGFβR2 and PD-1.

The Phase 1 study is expected to begin in 2026, focusing on third-line microsatellite stable colorectal cancer patients with and without liver metastases. Incyte will sponsor and conduct the trial while Adagene provides clinical supply of muzastotug.

Muzastotug, which has FDA Fast Track designation, is a masked anti-CTLA-4 antibody. Previous Phase 1b/2 trials combining muzastotug with Merck's pembrolizumab showed response rates in third-line microsatellite stable colorectal cancer patients. INCA33890 monotherapy has demonstrated clinical activity in immune checkpoint sensitive and insensitive cancers, including microsatellite stable colorectal cancer.

The planned study will include a dose escalation phase to evaluate safety and tolerability, followed by an efficacy expansion cohort in chemotherapy-refractory patients. Microsatellite stable colorectal cancer typically shows limited response to anti-PD-1/PD-L1 therapies.

Incyte recently initiated a Phase 3 study evaluating INCA33890 with standard chemotherapy in 700 first-line microsatellite stable colorectal cancer patients. Muzastotug is currently being evaluated in multiple ongoing clinical trials, including studies in combination with pembrolizumab and Sanofi's SAR445877.