Curium Group, PeptiDream and PDRadiopharma Enroll First Patient to Registrational Clinical Trial of Lu-PSMA-I&T for Prostate Cancer in Japan

Core Insights - Curium Group, in collaboration with PeptiDream Inc. and PDRadiopharma Inc., has initiated a registrational Phase 2 clinical trial for 177Lu-PSMA-I&T in Japan targeting patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) [1][2] Company and Industry Overview - 177Lu-PSMA-I&T is a radiotherapeutic agent designed to target PSMA, conjugated with Lutetium-177, and is being evaluated for its efficacy and safety in a multicenter, open-label, single-arm trial [2] - The trial will utilize bridging data from ongoing global clinical trials under the strategic collaboration between Curium and PDRadiopharma [2] - Prostate cancer remains prevalent in Japan, with approximately 90,000 to 100,000 new cases annually, highlighting a significant unmet medical need for effective therapies [5] - The overall survival rate for patients with mCRPC is approximately three years in clinical trial settings, indicating a critical demand for innovative treatment options [5] Clinical Trial Progress - The Phase 3 ECLIPSE trial for 177Lu-PSMA-I&T has met its primary endpoint, demonstrating a statistically significant benefit for patients with mCRPC [6] - Additional trials for 64Cu-PSMA-I&T are being conducted to diagnose biochemical recurrence and for newly diagnosed patients with high-risk prostate cancer [7] Partnership Details - Under the partnership, Curium and PDRadiopharma will collaborate on the clinical development of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory, manufacturing, and commercialization efforts [9] - Curium will support PDRadiopharma through technology transfer to establish manufacturing capabilities in Japan, including a high throughput Copper 64 manufacturing line [9] Company Profiles - Curium Pharma is a leading global radiopharmaceutical company focused on developing and supplying innovative cancer diagnostics and treatments, with a mission to improve patient care [10][11] - PeptiDream Inc. specializes in translating macrocyclic peptides into innovative medicines, with a focus on radiopharmaceuticals through its subsidiary PDRadiopharma [13][14] - PDRadiopharma has been a key player in the radiopharmaceutical field since 1968, currently marketing 22 radiodiagnostic products and 8 radiotherapeutic products in Japan [14]