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.

The planned Phase 2 study of up to 25 mCRPC patients is designed to efficiently assess the efficacy and safety of MRT-2359 plus ERLEADA® in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets, including patients naïve to next-generation AR inhibitors, should the activity in the AR mutant patient population confirm. The study will evaluate PSA response, RECIST response, duration of response, progression-free survival (PFS), radiographic progression-free survival (rPFS), and safety.

Monte Rosa recently announced additional, positive data from the company's ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC. The data were presented at the 2026 ASCO Genitourinary (GU) Cancers Symposium on February 26, 2026.