Core Insights - ORIC Pharmaceuticals announced promising preliminary efficacy and safety data for ORIC-944 in combination with androgen receptor inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][3] - The company reported a 59% PSA50 response rate and a 24% PSA90 response rate in the ongoing Phase 1b trial, indicating substantial clinical activity [1][6] - A concurrent financing of $125 million is expected to extend the company's cash runway into the second half of 2027, supporting further development of ORIC-944 [10] Efficacy Data - The Phase 1b trial showed a confirmed PSA50 response rate of 47% and a PSA90 response rate of 24%, with responses observed across all dose levels of ORIC-944 [1][6][7] - The majority of patients are still ongoing with treatment, with several approaching one year or more on therapy [1][7] Safety Profile - ORIC-944 demonstrated a favorable safety profile, with most adverse events classified as Grade 1 or 2, primarily mild to moderate gastrointestinal issues [2][8] - Diarrhea was the most common treatment-related adverse event, occurring in 53% of patients, with only one Grade 3 event reported [8] Trial Design and Next Steps - The ongoing Phase 1b trial is designed to explore different doses of ORIC-944 in combination with apalutamide and darolutamide, with the primary objective of determining the recommended Phase 2 dose [4][9] - Following the completion of the dose exploration phase, the company plans to evaluate candidate doses for optimization in the second half of 2025, leading to a global Phase 3 trial expected to start in the first half of 2026 [9] Corporate Update - The $125 million financing is anticipated to close on May 29, 2025, and will support the company's operations through the primary endpoint readout of the first Phase 3 trial [10]
ORIC® Pharmaceuticals Announces Potentially Best-In-Class Preliminary Efficacy and Safety Data from Ongoing Phase 1b Trial of ORIC-944 in Combination with AR Inhibitors for the Treatment of Patients with mCRPC