1. MRT-2359 shows 100% PSA response in AR-mutant mCRPC patients. 2. Company plans a Phase 2 study for MRT-2359 in 2026. 3. MRT-2359 demonstrates strong safety profile with mainly mild events. 4. Significant opportunity seen for MRT-2359 in evolving prostate cancer treatments. 5. Conference call scheduled for updates on MRT-2359 and MRT-8102.
FAQ
Why Bullish?
The strong efficacy results and future study plans enhance GLUE's value perception, similar to prior biotech successes with promising trial data boosting valuations post-announcement.
How important is it?
MRT-2359 results directly enhance GLUE's clinical outlook, indicating substantial future value and investment interest in upcoming studies.
Why Long Term?
Positive clinical trial results generally lead to long-term stock price increases as pipelines advance and potential FDA submissions loom, particularly when based on innovative therapies.
Related Companies
Monte Rosa Therapeutics Highlights Promising MRT-2359 Clinical Results in Prostate Cancer
BOSTON, Dec. 16, 2025 (GLOBE NEWSWIRE) – Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a biotechnology company focused on developing innovative molecular glue degrader (MGD)-based therapies, has announced compelling interim results from its ongoing Phase 1/2 trial evaluating MRT-2359 combined with enzalutamide in heavily pretreated patients suffering from metastatic castration-resistant prostate cancer (mCRPC).
Interim Results Indicate Strong Efficacy
The latest data reveal a remarkable 100% PSA response rate among patients with androgen receptor (AR) mutations, demonstrating the treatment potential of MRT-2359. Specifically, the study reported:
- 100% disease control rate in AR mutation patients, including 4 of 4 patients achieving a PSA response.
- Two patients exhibited RECIST-confirmed responses, while the remaining two maintained stable disease.
- Overall disease control rate (DCR) in the study population reached 64%.
The combination therapy was well-tolerated, with adverse events primarily classified as Grade 1-2, affirming the safety of MRT-2359.
Plans for Future Clinical Studies
With these encouraging results, Monte Rosa plans to initiate a new Phase 2 study targeting AR mutant patients in 2026. This signal-confirming study will focus on evaluating MRT-2359 in combination with a second-generation AR inhibitor.
“We believe these results are especially promising, especially given the heavy pretreatment of patients, which typically includes chemotherapy and experimental therapies,” stated Dr. Markus Warmuth, CEO of Monte Rosa Therapeutics. “Our biomarker studies suggest a mechanism of action for MRT-2359 that may operate independently of traditional AR signaling, positioning it as a novel treatment option in the evolving prostate cancer therapeutic landscape.”
Study Design and Patient Profile
The Phase 1/2 trial evaluated the efficacy of MRT-2359 using doses of 0.5 mg and 0.75 mg administered orally on a 21-days-on, 7-days-off schedule alongside enzalutamide. The study population consisted of 20 pretreated patients, with 75% having previously received second-generation AR inhibitors and 80% having undergone taxane chemotherapy. Additionally, 55% were treated with Pluvicto®.
All patients were required to be evaluable for measurable disease. Analysis revealed a remarkable 100% DCR in patients with AR mutations, with further studies planned to confirm the ongoing project's clinical activity.
Upcoming Presentations and Events
Monte Rosa will present updated data from the Phase 1/2 study of MRT-2359 at the upcoming ASCO Genitourinary Cancers Symposium scheduled for February 2026. They will also host a conference call and a webcast today at 8:00 AM ET, providing further insights into their research and findings.
For investors, registration details for the conference call and access to the presentation will be available on the company’s website, and an archived version will remain accessible for 30 days following the event.
About Monte Rosa Therapeutics and MRT-2359
Monte Rosa Therapeutics is pioneering the development of innovative MGD-based therapies targeting significant unmet medical needs. MRT-2359 is an investigational treatment that offers a unique approach in the landscape of cancer therapy, particularly for those with AR mutations.
“Our findings support continuing to explore the clinical potential of MRT-2359 in mCRPC and related cancers, with the hope of improving outcomes for patients with limited available treatment options,” added Dr. Filip Janku, Chief Medical Officer.