ORIC Pharmaceuticals announced encouraging early safety and efficacy data from a Phase 1b trial of ORIC-944 combined with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The company also highlighted operational achievements in 2024, including collaborations with Johnson & Johnson and Bayer, and provided anticipated milestones for the next 18 months. ORIC expects its current cash reserves to fund operations into late 2026.
These developments are noteworthy because they demonstrate progress in addressing treatment resistance in difficult-to-treat cancers. The early clinical data for ORIC-944, particularly the durable PSA responses, suggest the combination therapy could offer a new treatment option for mCRPC patients who have limited therapeutic choices. The collaborations with established pharmaceutical companies like Johnson & Johnson and Bayer validate ORIC’s approach and provide external resources to accelerate development. Finally, the extended cash runway allows ORIC to pursue its ambitious clinical development plans without immediate funding concerns.
ORIC-944, a PRC2 inhibitor, demonstrated promising results when combined with apalutamide. In the first two dose escalation cohorts, three out of six patients achieved a PSA50 response, with two of those achieving a PSA90 response. Importantly, these responses were sustained, with one PSA90 response ongoing at 38 weeks. The combination was well-tolerated, with mostly Grade 1 and 2 adverse events. Parallel development of ORIC-944 with darolutamide is also underway, showing similar preliminary clinical activity. Beyond ORIC-944, ORIC is progressing ORIC-114, an EGFR/HER2 inhibitor, in non-small cell lung cancer (NSCLC), with multiple data readouts expected in the coming year and a half.
ORIC’s pipeline progress, strategic partnerships, and financial stability position the company to potentially initiate registrational trials for both ORIC-114 and ORIC-944 within the next two years. The anticipated data readouts over the next 18 months will be crucial for validating the clinical potential of these drug candidates and informing the design of pivotal studies. This progress could lead to new treatment options for patients with advanced prostate cancer and NSCLC, areas of significant unmet medical need.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
