Monte Rosa Therapeutics reported interim results from its Phase 1/2 study of the GSPT1‑directed molecular glue degrader MRT‑2359 in combination with enzalutamide. In the biomarker‑selected cohort of four patients whose tumors carried androgen‑receptor mutations, every patient achieved a prostate‑specific antigen (PSA) decline of at least 50 %, yielding a 100 % PSA response rate. The same subgroup also achieved a 100 % disease‑control rate, with two patients meeting RECIST criteria for objective response.
Across the broader study population, the overall disease‑control rate was 64 %. No grade 3 or higher adverse events were reported, underscoring the tolerability of the combination. The data cutoff for these interim results was December 3 2025, and the study enrolled heavily pretreated metastatic castration‑resistant prostate cancer patients who had previously received second‑generation androgen‑receptor inhibitors, chemotherapy, or radioligand therapy.
Monte Rosa plans to launch a signal‑confirming Phase 2 study of MRT‑2359 in 2026, targeting both AR‑mutant and AR‑signaling‑dependent patients. Updated data are expected at the ASCO Genitourinary Cancers Symposium in February 2026. The company’s broader pipeline includes other molecular glue degraders, such as MRT‑8102 for inflammatory diseases and MRT‑6160 for autoimmune disorders, with early 2026 updates anticipated.
Financially, Monte Rosa remains well‑capitalized, holding $377 million in cash and equivalents at the end of 2024, sufficient to fund operations through 2028. A $150 million upfront payment from Novartis for its VAV1‑directed degrader MRT‑6160 further strengthens the balance sheet. The positive interim data reinforce investor confidence, prompting Wells Fargo to upgrade Monte Rosa to Overweight with a price target of $22.
The 100 % PSA response in a heavily pretreated, biomarker‑selected cohort signals that the molecular glue degrader platform can overcome resistance mechanisms that limit current therapies. By degrading GSPT1, MRT‑2359 disrupts protein synthesis in MYC‑driven tumors, offering a novel mechanism of action distinct from traditional androgen‑receptor blockade. The absence of high‑grade toxicity suggests that the drug can be combined safely with enzalutamide, potentially expanding treatment options for patients with limited alternatives.
The company’s strategic focus on biomarker‑driven development, coupled with a robust financial position and a growing pipeline, positions Monte Rosa to capitalize on the unmet need in metastatic castration‑resistant prostate cancer. The interim results provide early evidence that the platform can deliver clinically meaningful outcomes, supporting the company’s roadmap toward regulatory approval and market entry.
The positive data also highlight the broader potential of molecular glue degraders beyond oncology, as the company advances candidates for inflammatory and autoimmune indications. This diversification mitigates concentration risk and could unlock additional revenue streams in the coming years.
Monte Rosa’s leadership emphasized the significance of the interim results, noting that the 100 % PSA response rate in the AR‑mutant subgroup is a rare achievement in this patient population and underscores the platform’s therapeutic promise.
The company’s next milestones include the Phase 2 study launch, data presentation at ASCO, and continued progress on its non‑oncology pipeline, all of which will shape the company’s trajectory and valuation in the medium term.
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