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Monte Rosa Therapeutics Announces Clinical Supply Agreement to Support Phase 2 Trial Evaluating MRT-2359 in Combination with Apalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
MRT-2359 is an investigational, orally bioavailable, GSPT1-directed molecular glue degrader that has shown compelling clinical activity in combination with
About this update from Monte Rosa Therapeutics, Inc.
[{"type":"text","content":"MRT-2359 is an investigational, orally bioavailable, GSPT1-directed molecular glue degrader that has shown compelling clinical activity in combination with androgen receptor (AR) inhibition in heavily pretreated metastatic castration-resistant prostate cancer (mCRPC) patients with AR mutations in an ongoing Phase 1/2 clinical study Monte Rosa plans to initiate a new, signal-confirming Phase 2 study of MRT-2359 in combination with apalutamide targeting AR mutant patients in Q3 2026 BOSTON, March 16, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the company has entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with androgen receptor (AR) mutations in a planned Phase 2 study expected to initiate in the third quarter of 2026. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa. ERLEADA® is an AR inhibitor developed by Janssen Research and Development, LLC, indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) and patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Under the terms of the agreement, Monte Rosa will conduct and sponsor the trial and Johnson & Johnson will provide ERLEADA® as part of a supply agreement. “We are pleased to enter into this supply agreement with Johnson & Johnson to further explore the potential of MRT-2359 in combination with next-generation AR inhibitors such as apalutamide in patients with advanced prostate cancer,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “Based on the compelling clinical activity observed to date in heavily pretreated patients with AR mutations, we believe this combination approach holds significant promise. Data generated from these studies have the potential to further confirm MRT-2359’s clinical activity and may position the program for advancement into registrational studies, representing an important step forward for prostate cancer patients with limited therapeutic options for this respective patient population.” Th...