Adagene Collaborates with Incyte to Evaluate New Therapy

Adagene (ADAG) announced a clinical collaboration with Incyte (INCY) to evaluate the combination of muzastotug and INCA33890, a TGFbetaR2 PD-1 bispecific antibody, in patients with microsatellite stable colorectal cancer with or without liver metastases. Muzastotug in combination with Merck's (MRK) anti-PD-1 therapy, Keytruda has demonstrated encouraging overall response rates and durable responses in a Phase 1b/2 trial in 3L MSS CRC patients. As a monotherapy, INCA33890 has demonstrated promising clinical efficacy and safety in immune checkpoint sensitive and insensitive cancers, including MSS CRC with and without liver metastases. Incyte has recently initiated a Phase 3 study evaluating bevacizumab and Folfox with or without INCA33890 in 700 first-line MSS CRC patients. Muzastotug, a masked anti-CTLA-4 SAFEbody with FDA Fast Track designation, is currently being evaluated in multiple ongoing studies, including: a Phase 1b/2 clinical trial in combination with pembrolizumab in MSS CRC patients without liver metastases. A randomized Phase 2 study in MSS CRC patients without liver metastases designed to determine the optimal dose to advance into a Phase 3 registration trial. A Phase 1b/2 dose escalation and expansion study of muzastotug in combination with Sanofi's SAR445877 in adults with advanced solid tumors. Under terms of the agreement, Incyte will sponsor and conduct the study and Adagene will provide clinical trial supply of muzastotug. The planned dose escalation portion of the study will evaluate safety and tolerability, followed by an efficacy expansion cohort in patients with chemotherapy-refractory MSS CRC patients with and without liver metastases. MSS CRC is well-known to be largely non-responsive to anti-PD-1 / PD-L1 therapy. INCA33890 monotherapy has demonstrated promising initial clinical efficacy and safety in immune checkpoint sensitive/insensitive tumors, including MSS CRC with and without liver metastases.