Business
Monte Rosa Therapeutics Provides Development Progress Updates on MRT-2359 and MRT-6160
Ongoing Phase 1/2 Study of MRT-2359 for MYC-driven solid tumors demonstrates favorable safety and pharmacodynamic profile dosing 0.5 mg using a 21/7 schedule;
About this update from Monte Rosa Therapeutics, Inc.
[{"type":"text","content":"Ongoing Phase 1/2 Study of MRT-2359 for MYC-driven solid tumors demonstrates favorable safety and pharmacodynamic profile dosing 0.5 mg using a 21/7 schedule; currently assessing 0.75 mg dose level; final determination of recommended Phase 2 dose and updated clinical results anticipated in H2 2024 IND submission achieved for MRT-6160, a VAV1-directed MGD in development for systemic and neurological autoimmune diseases; initiation of Phase 1 SAD/MAD study expected this summer with Phase 1 clinical data anticipated in Q1 2025 BOSTON, June 27, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today 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. “We are pleased with the progress of our two lead programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “We continue to successfully recruit and advance our ongoing MRT-2359 Phase 1/2 study. We are encouraged by our initial safety and pharmacodynamic assessment of the 0.5 mg dose using the 21 days on, 7 days off regimen and, as such, we consider the 0.5mg dose with the 21 days on, 7 days off regimen a potential recommended Phase 2 dose. Importantly, this regimen allows for dosing of MRT-2359 twice as frequently per cycle compared to the 5 days on, 9 days off regimen previously explored in our study. Based on the favorable safety assessment for the 0.5 mg dose, we initiated a 0.75 mg, 21 days on, 7 days off dose cohort, which is currently ongoing. In the second half of the year, we expect to make a determination of our definitive recommended Phase 2 dose, share updated clinical efficacy and safety results from the dose escalation arm of the trial, and initiate enrollment of our Phase 2 expansion cohorts.” Dr. Warmuth continued, “Moreover, today we are excited to announce the submission of our Investigational New Drug (IND) application to the U.S Food and Drug Administration (FDA) for MRT-6160, a highly selective and orally bioavailable MGD directed against VAV1. This milestone positions us to soon have our second highly promising program in the clinic, pending FDA clear...