On October 1, 2024 Curium, a world leader in nuclear medicine, reported that it has entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T (Press release, Curium Pharma, OCT 1, 2024, View Source [SID1234646974]). 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 tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair.

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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, commercialization, 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.

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these powerful targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their highly promising prostate cancer targeting radiopharmaceuticals to patients in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to partner with Curium in the development of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T, highly promising products for both the diagnosis and treatment of PSMA-expressing prostate cancer. We look forward to working with Curium to deliver these much-needed agents to prostate cancer patients in Japan as quickly as possible."

Chaitanya Tatineni, Curium’s CEO International Markets commented: "As a global innovator in the field of radiopharmaceuticals with a promising late-stage oncology pipeline, Curium is delighted to partner with PDRadiopharma which has more than four decades of experience in Japan. Curium and PDRadiopharma plan to leverage their complementary strengths to accelerate the development of innovative products for the benefit of prostate cancer patients in Japan."

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 (ClinicalTrials.gov identifier; NCT05204927). ECLIPSE is a multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer. The ECLIPSE trial enrolled over 400 patients, across 51 trial sites in the United States and Europe.

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 (ClinicalTrials.gov identifier NCT06235099) and SOLAR STAGE testing the diagnostic performance in men with newly diagnosed unfavorable intermediate- to high-risk prostate cancer (ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer. PSMA-targeted PET/CT imaging is increasingly emerging as a highly sensitive method for detection of locally recurrent or metastatic lesions in the context of biochemical recurrence and for localization of primary prostate cancer.

Curium and PDRadiopharma have a long-standing relationship in the radiopharmaceutical field.