KAWASAKI, Japan — PeptiDream Inc., a Kanagawa-based biopharmaceutical company (Tokyo: 4587), together with its wholly owned subsidiary PDRadiopharma Inc. and Curium Group, a global leader in nuclear medicine, announced the enrollment of the first patient in a registrational Phase 2 clinical trial (jRCT: 2031250225) in Japan for 64Cu-PSMA-I&T, a PET imaging agent targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.
64Cu-PSMA-I&T is being developed as a diagnostic PET imaging radiopharmaceutical labeled with Copper-64, paired with its therapeutic counterpart 177Lu-PSMA-I&T. The program is part of a strategic collaboration between PDRadiopharma and Curium to advance innovative radiopharmaceuticals for prostate cancer in Japan.
The open-label, single-arm Phase 2 study will assess the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. Approximately 70 patients newly diagnosed with unfavorable intermediate, high, or very high-risk prostate cancer and scheduled for prostatectomy with pelvic lymph node dissection will be enrolled. The study will serve as a registrational trial in Japan and will incorporate bridging data from Curium’s ongoing global clinical trials.
In parallel, a clinical trial of 177Lu-PSMA-I&T is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).
Patrick C. Reid, President and CEO of PeptiDream, said, “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 targeted therapies, and we are thrilled to accelerate those efforts by partnering with Curium to bring their prostate cancer-targeting radiopharmaceuticals to patients in Japan.”
Masato Murakami, President of PDRadiopharma and CMO of PeptiDream, added, “We are excited to initiate the development of 64Cu-PSMA-I&T in Japan. Both 64Cu-PSMA-I&T and 177Lu-PSMA-I&T have potential as diagnostic and therapeutic products for PSMA-expressing prostate cancer. There is significant demand for PSMA PET imaging among urologists in Japan, and through our collaboration with Curium, we aim to meet this need and provide new medical treatments for patients.”
Renaud Dehareng, CEO of Curium Group, commented, “Conducting these registrational trials in partnership with PeptiDream and PDRadiopharma marks a major milestone in expanding access to cutting-edge radiopharmaceuticals for prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge, we are well-positioned to deliver transformative solutions to patients in Japan.”
