Shares of ORIC Pharmaceuticals (ORIC) surged more than 20% in the pre-market hours today after announcing potentially best-in-class preliminary efficacy and safety data from the ongoing early-stage study of its novel, once-daily candidate, ORIC-944, for prostate cancer. ORIC-944, in combination with AR inhibitors, J&J’s (JNJ) Erleada (apalutamide) and Bayer’s (BAYRY) Nubeqa (darolutamide), is being evaluated in the phase Ib study for treating patients with metastatic castration-resistant prostate cancer (mC ...

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]

Core Insights - ORIC Pharmaceuticals, Inc. presented preclinical data on ORIC-944, a selective allosteric inhibitor of PRC2, at the 2025 AACR Annual Meeting, showing improved progression-free survival (PFS) when combined with androgen receptor pathway inhibitors (ARPIs) in prostate cancer models [1][2][6] Group 1: ORIC-944 Overview - ORIC-944 is characterized as a potent and selective allosteric inhibitor of PRC2, demonstrating best-in-class properties in preclinical studies, including favorable pharmacokinetics and a clinical half-life of approximately 20 hours [3][6] - The drug is currently being evaluated in a Phase 1b trial in combination with ERLEADA (apalutamide) and NUBEQA (darolutamide) for prostate cancer [3][6] Group 2: Clinical Implications - The data presented indicate that ORIC-944 enhances PFS in both castration-sensitive and castration-resistant prostate cancer models, suggesting its potential to reverse the evolution of prostate cancer [2][6] - ORIC-944 demonstrated transcriptional and antitumor synergy with ARPIs, reinforcing its role in blocking prostate tumor adaptation and restoring luminal features [6] Group 3: Company Background - ORIC Pharmaceuticals is focused on developing treatments that address mechanisms of therapeutic resistance in cancer, with ORIC-944 and ORIC-114 as key product candidates [4]