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Monte Rosa Therapeutics Announces Interim PK/PD and Clinical Data for MRT-2359 in Phase 1/2 Trial for MYC-Driven Solid Tumors
Optimal levels of degradation of GSPT1 in peripheral blood mononuclear cells and tumors observed at all doses, consistent with preclinical studies Tumor size
About this update from Monte Rosa Therapeutics, Inc.
[{"type":"text","content":"Optimal levels of degradation of GSPT1 in peripheral blood mononuclear cells and tumors observed at all doses, consistent with preclinical studies Tumor size reductions observed in patients with biomarker-positive tumors Safety profile supports further clinical development of MRT-2359 Conference call and webcast at 8:00 a.m. ET today BOSTON, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced interim data from the Phase 1 dose escalation part of its ongoing Phase 1/2 open-label, multicenter study of MRT-2359 in patients with MYC-driven solid tumors, including lung cancers and high-grade neuroendocrine cancer. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered by Monte Rosa Therapeutics. Cancers driven by MYC overexpression have been demonstrated to be dependent on GSPT1, creating a therapeutic opportunity. Interim clinical data from the MRT-2359 study have demonstrated favorable tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles in heavily pre-treated patients with lung cancers and high-grade neuroendocrine cancer. In addition, MRT-2359 has been observed to significantly reduce GSPT1 protein levels in patient tumors and has shown evidence of tumor size reductions, including partial responses, in heavily pretreated patients with biomarker-positive tumors. Monte Rosa is continuing with dose level and schedule optimization in this ongoing study. “We’re highly encouraged by the safety profile, the depth of pharmacodynamic modulation of GSPT1 in tumors, and even more so by the early evidence of anti-tumor activity of MRT-2359 in patients with biomarker-positive cancers,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “We believe these results, the first ever to show clinical activity of a rationally designed molecular glue degrader in solid tumors, represent an important advance for the field and underscore the potential for MRT-2359 to benefit patients living with a variety of difficult-to-treat cancers. We are excited to learn more about the clinical profile of MRT-2359 in our ongoing Phase 1/2 clinical study, and early next year we plan to provide further clarity on the expected timing for the full Phase 1 data disclosure in ...