Curium Group Completes Patient Dosing in 64Cu-PSMA-I&T Phase 2 Trial for Prostate Cancer in Japan

With patient dosing now complete, Curium Group and its partners PeptiDream and PDRadiopharma are entering the data analysis phase of a registrational Phase 2 study for 64Cu-PSMA-I&T in Japan, a step that moves the Copper-64 PET radiopharmaceutical closer to a domestic regulatory submission and tests the GMP supply chain and short shelf-life logistics that define this modality.

The open-label, single-arm study evaluated the sensitivity, specificity, and safety of 64Cu-PSMA-I&T in Japanese patients newly diagnosed with unfavorable intermediate, high, or very high-risk prostate cancer scheduled for prostatectomy with pelvic lymph node dissection. Japan records approximately 90,000 to 100,000 new prostate cancer cases annually, according to the National Cancer Center Japan, establishing the commercial and public-health context for a successful submission.

Under the partnership structure, PDRadiopharma, a wholly owned subsidiary of PeptiDream, will lead regulatory filing, manufacturing, and commercialization activities in Japan, while Curium retains responsibility for global development. That division of labor places 21 CFR Part 211-equivalent GMP compliance and local manufacturing readiness squarely on PDRadiopharma's operational agenda as data packages are assembled for Japanese authorities.

Results from the Japan study are expected to be submitted alongside data from Curium's ongoing global trials, including the Phase 3 SOLAR RECUR (NCT06235099) and SOLAR STAGE (NCT06235151) trials. The earlier Phase 1/2 SOLAR trial met co-primary endpoints for region-level correct localization rate and patient-level correct detection rate in histologically proven prostate cancer, providing the evidentiary foundation the Japan package will build on.

The diagnostic program runs in parallel with a theranostic strategy: Curium announced in February 2026 that a registrational trial of the therapeutic counterpart, 177Lu-PSMA-I&T, is advancing in patients with metastatic castration-resistant prostate cancer (mCRPC), consistent with the Phase 3 ECLIPSE trial (NCT05204927) that previously met its primary endpoint. For QA and regulatory leads tracking the theranostics space, the convergence of a PET diagnostic and a lutetium therapeutic under a single partnership framework raises coordinated submission and post-approval manufacturing surveillance considerations across two distinct radioisotope supply chains.

The timeline to regulatory submission in Japan will depend on the outcome of data analysis now underway, with PDRadiopharma's local infrastructure serving as the critical path variable for both filing readiness and commercial-scale GMP production of a short-lived radiopharmaceutical.

Source: Curium Group via GlobeNewswire, 11 June 2026.