Paris-based Curium, a world leader in nuclear medicine, has entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialisation in Japan of ¹⁷⁷Lu-PSMA-I&T and ⁶⁴Cu-PSMA-I&T.

The two agents ¹⁷⁷Lu-PSMA-I&T and ⁶⁴Cu-PSMA-I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumours with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair.

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of ¹⁷⁷Lu-PSMA-I&T and ⁶⁴Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialszation, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan, including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases, with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

¹⁷⁷Lu-PSMA-I&T, a PSMA inhibitor conjugated with the radioisotope Lutetium 177, is currently being tested by Curium in a global pivotal Phase 3 ECLIPSE trial, while ⁶⁴Cu-PSMA-I&T PET is currently being investigated in 2 multicenter Phase 3 trials- SOLAR RECUR testing the diagnostic performance in men with biochemical recurrence of prostate cancer, and SOLAR STAGE testing the diagnostic performance in men with newly diagnosed unfavorable intermediate- to high-risk prostate cancer.