Promontory Therapeutics Advances Phase 3 Study for Prostate Cancer Drug PT-112 After Successful FDA Meeting

Promontory Therapeutics Advances Clinical Development Plan for PT-112 in Prostate Cancer

Promontory Therapeutics Inc., a clinical stage biotech firm, recently announced a significant milestone in its efforts to develop PT-112, a promising therapeutic agent for patients suffering from metastatic castration-resistant prostate cancer (mCRPC). In an important meeting with the U.S. Food and Drug Administration (FDA), the company reached an agreement on the proposed design of a Phase 3 registrational study, marking a pivotal stage in its clinical development pathway.

Successful End of Phase 2 Meeting

The End of Phase 2 (EOP2) meeting showcased the FDA's endorsement of the dosing regimen and study design proposed by Promontory. This approval is crucial as it sets the foundation for the upcoming Phase 3 study. The discussions covered essential components, including the patient population to be targeted, the study comparator, and the key endpoints that will guide the evaluation of PT-112's efficacy.

In line with FDA's Project Optimus framework, the dialogue confirmed the necessity of an interim analysis which could facilitate a potential early approval for PT-112—before the complete Phase 3 trials are concluded. This pathway represents a significant opportunity to expedite access to PT-112 for patients in need.

Moving Forward with Phase 3 Study

Promontory is now focused on detailing its Phase 3 study design based on the feedback received from the FDA. This includes the preparation of the full study submission for comprehensive review. As part of its strategy, the company is also planning to engage with regulatory authorities in other countries to expand its clinical research footprint.

The Phase 2 study had previously involved patients in both the United States and France, with three distinct randomized dosing arms for PT-112. Preliminary findings and immune response biomarker data were recently shared at the American Association of Cancer Research (AACR) 2025 Annual Meeting, providing initial insight into the drug's potential effectiveness.

Upcoming Presentations

Further, upcoming data on PT-112's clinical outcomes will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for June 2nd, 2025. These presentations are expected to provide significant insights into PT-112’s clinical performance in treating mCRPC, underpinning the company’s commitment to advancing cancer treatment options significantly.

About Promontory Therapeutics

Founded in New York, Promontory Therapeutics is dedicated to developing small molecule agents that modulate the immune response against cancer. The company has generated encouraging clinical data across six studies with PT-112, indicating strong anti-cancer activity when administered alone or in combination with other treatments. Among its groundbreaking endeavors, Promontory has been recognized as the first international member of the Paris-Saclay Cancer Cluster in France, a key biotechnology hub focusing on oncology.

With ongoing research initiatives that span the United States, Europe, and Asia, Promontory Therapeutics is driven to maximize the therapeutic potential of PT-112 and contribute meaningful advancements to the field of oncology. The active Phase 2 trial evaluating PT-112 monotherapy in thymic epithelial tumors, a rare condition with no existing FDA-approved treatments, further complements the company's innovative trajectory.

For more information about Promontory Therapeutics and its innovative work on PT-112, visit www.PromontoryTx.com.