Monte Rosa Therapeutics, Inc. (GLUE), a clinical-stage biotechnology company, announced that the company has entered into a supply agreement with Johnson & Johnson(JNJ) to evaluate its MRT-2359 in combination with JNJ's ERLEADA or Apalutamide for the treatment of metastatic castration-resistant prostate cancer or mCRPC.
Following the news, GLUE is up 4.74% at $16.78.
As per the terms of the pact, Monte Rosa will conduct and sponsor the trial, and Johnson & Johnson will provide ERLEADA under a supply agreement.
MRT-2359 is Monte Rosa's investigational, orally bioavailable, GSPT1-directed molecular glue degrader.
ERLEADA is an androgen receptor 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).
Monte Rosa plans to initiate a new, signal-confirming Phase 2 study of MRT-2359 in combination with Apalutamide in AR-mutant patients in the third quarter of 2026.
The planned phase 2 study, enrolling up to 25 mCRPC patients, is designed to evaluate the efficacy and safety of MRT-2359 plus ERLEADA in patients with AR mutations.
The study will evaluate PSA response, RECIST response, duration of response, progression-free survival (PFS), radiographic progression-free survival (rPFS), and safety.
If the activity in the AR mutant patient population is confirmed, the study may expand to other additional patient subsets, including patients naïve to next-generation AR inhibitors.
Currently, MRT-2359, in combination with the AR inhibitor Enzalutamide, is being investigated by Monte Rosa in an ongoing Phase 1/2 study in patients with mCRPC.
According to the firm, in the ongoing Phase 1/2 clinical study for heavily pretreated metastatic castration-resistant prostate cancer (mCRPC) patients with AR mutations, MRT-2359 showed compelling clinical activity in combination with androgen receptor (AR) inhibition.
For the third quarter ended September 30, 2025, Monte Rosa reported collaboration revenue of $12.8 million, compared to $9.2 million in the prior year.
Net loss for the third quarter of 2025 expanded to $27.1 million from $23.9 million in the prior year.
Cash, cash equivalents, and restricted cash were $396.2 million as of September 30, 2025.
GLUE has traded between $3.50 and $25.77 in the last year. The stock closed Friday's trade at $16.02.
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