Monte Rosa Therapeutics, Inc. announced progress updates for its two lead programs, MRT-2359, an MGD being developed for MYC-driven solid tumors, and MRT-6160, a VAV1-directed MGD in development for systemic and neurological autoimmune diseases. Monte Rosa continues to evaluate MRT-2359 in a Phase 1/2 clinical trial in MYC-driven solid tumors. The Company has completed enrollment of the 0.5 mg, 21 days on, 7 days off dose escalation cohort, and tolerability has been favorable with an AE profile similar to what has been observed using the 5 days on, 9 days off schedule at the same dose level.

Enrollment is ongoing in the 0.75 mg, 21 days on, 7 days off dose escalation cohort. The Company is evaluating possible Phase 2 expansion cohorts, and anticipates utilizing a two-stage design to enroll patients to evaluate responses in each selected expansion cohort before proceeding with further enrollment. MRT-6160 is on track for initiation of a Phase 1 SAD/MAD study this summer with Phase 1 clinical data expected in First Quarter 2025.

Monte Rosa expects to subsequently initiate proof-of-concept (POC) studies in autoimmune/inflammatory diseases including ulcerative colitis and rheumatoid arthritis, with additional potential POC studies in dermatology, rheumatology, and neurology indications. Preclinical efficacy data in multiple models of autoimmune/inflammatory diseases and preclinical GLP toxicology data suggest the potential for a highly differentiated profile in T-cell, T/B-cell, and Th17-mediated systemic and neurologic autoimmune diseases.