PeptiDream, PDRadiopharma and Curium Group Announce Completion of Patient Dosing in Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan

• Completion of patient dosing in the registrational Phase 2 clinical trial of ⁶⁴Cu-PSMA-I&T —a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells

• Data analysis is now underway to support future regulatory submission in Japan

KAWASAKI, Japan--(BUSINESS WIRE)--PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream"), PDRadiopharma Inc. (President: Masato Murakami, Headquarters: Chuo-ku, Tokyo, Japan, “PDRadiopharma”), a wholly owned subsidiary of PeptiDream, and Curium Group, a world leader in nuclear medicine (CEO: Renaud Dehareng, Headquarters: Boston, Massachusetts, the United States), today announced that patient dosing has been completed in the registrational Phase 2 clinical trial (jRCT: 2031250225) of ⁶⁴Cu-PSMA-I&T in Japan.

⁶⁴Cu-PSMA-I&T is a positron emission tomography (PET) radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), a cell-surface protein commonly highly expressed in prostate cancer cells. ⁶⁴Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64.

The trial is being conducted under the strategic collaboration between Curium and PDRadiopharma, a wholly owned subsidiary of PeptiDream. The open-label, single-arm Phase 2 study is designed to evaluate 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 and scheduled for prostatectomy with pelvic lymph node dissection.

The results from this study, together with data from Curium’s ongoing global clinical trials, are expected to support future regulatory submission in Japan.

In parallel, as announced in February 2026, a registrational clinical trial of the therapeutic counterpart, ¹⁷⁷Lu-PSMA-I&T, is being advanced to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC), as part of a theranostic approach.

Patrick C. Reid, President & CEO of PeptiDream commented: “The completion of patient dosing marks an important milestone in the development of ⁶⁴Cu-PSMA-I&T in Japan. This program represents a key component of our growing radiopharmaceutical pipeline and our broader theranostics strategy. We would like to thank the patients, investigators and clinical sites for their participation and support.”

Masato Murakami, President of PDRadiopharma & Executive Vice President of PeptiDream commented: “We are pleased to have completed patient dosing in this clinical trial for ⁶⁴Cu-PSMA-I&T in Japan. This milestone reflects the strong collaboration between PDRadiopharma, PeptiDream and Curium, and represents an important step in the development of PSMA-targeted theranostics for patients with prostate cancer in Japan. We would like to express our sincere appreciation to the patients, investigators and clinical staff who have supported this study, and we will continue to work closely with our partners toward the next stages of development in Japan."

Renaud Dehareng, CEO of Curium Group commented: “Conducting these trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to patients with prostate cancer in Japan.”

Global Clinical Trial information
Phase 3 ECLIPSE trial: ClinicalTrials.gov identifier; NCT05204927
Phase 3 SOLAR RECUR: ClinicalTrials.gov identifier NCT06235099
SOLAR STAGE trial: ClinicalTrials.gov identifier NCT06235151