Curium Group, PeptiDream and PDRadiopharma 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 for 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

BOSTON, June 11, 2026 (GLOBE NEWSWIRE) -- Curium Group announced today that together with PeptiDream Inc. and PDRadiopharma Inc., patient dosing has been completed in the registrational Phase 2 clinical trial for 64Cu-PSMA-I&T in Japan.

64Cu-PSMA-I&T is a PET radiopharmaceutical targeting PSMA. 64Cu-PSMA-I&T is being assessed as a PET agent labeled with the radioisotope Copper-64. The trial is conducted under the strategic collaboration between PDRadiopharma, a wholly owned subsidiary of PeptiDream, and Curium, aiming at advancing innovative diagnostic radiopharmaceuticals for prostate cancer in Japan.

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 are 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, Curium announced in February, 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.

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.”

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.”

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*1). *1: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial - 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

Phase 3 SOLAR RECUR and SOLAR STAGE trial - 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, 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 prostate cancer.  

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 64Cu-PSMA-I&T and 177Lu-PSMA-I&T and 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.

About Curium

Curium Pharma is a leading global radiopharmaceutical company with proven expertise in the development, manufacturing and supply of radiopharmaceuticals that transform the way cancer is diagnosed and treated. Headquartered in Boston with offices around the world, Curium's mission is to find new and better ways to diagnose and treat cancer.

With a global footprint that extends to more than 70 countries, a skilled and dedicated team of over 5,000 employees, and four manufacturing sites, Curium is uniquely qualified to meet the significant supply and distribution of established products that underlie success in the radiopharmaceuticals market. Curium's global leadership is embodied in a diverse and extensive portfolio of over 45 products, that advance patient care for a wide range of cancers.

Curium's pioneering legacy in nuclear medicine is the foundation of the company's dedication to innovation and portfolio expansion to cancer therapeutics, particularly in neuroendocrine tumors and with a late-stage pipeline exploring opportunities in prostate cancer.

To learn more, visit www.curiumpharma.com.

About PeptiDream Inc.

PeptiDream Inc. (Tokyo Stock Exchange Prime Section 4587) is leading the translation of macrocyclic peptides into a whole new class of innovative medicines to address unmet medical needs and improve the quality of life of patients worldwide. In its radiopharmaceutical business, through its wholly-owned subsidiary PDRadiopharma, PeptiDream markets and sells a number of approved radiopharmaceuticals and radiodiagnostics in Japan, as well as leveraging its proprietary Peptide Discovery Platform System (PDPS) technology to discover and develop a deep pipeline of innovative targeted radiotherapeutics and radiodiagnostics, spanning both wholly-owned internal programs and globally partnered programs. In its non-radiopharmaceutical business, PeptiDream is similarly leveraging PDPS to discover and develop a broad and diverse pipeline of investigational peptide therapeutics, peptide drug conjugates (PDC) and multi-functional peptide conjugates (MPC) across an extensive global network of discovery and development partners. PeptiDream is headquartered in Kawasaki, Japan. For more information about our company, science and pipeline, please visit www.peptidream.com/en/

About PDRadiopharma

PDRadiopharma, a wholly-owned subsidiary of PeptiDream from 2022, has been providing high-quality radiopharmaceuticals through the research and development, manufacturing, regulatory and sales as a forerunner in the field in radiopharmaceuticals, since it started its business in 1968. PDRadiopharma currently markets 21 radiodiagnostic products (spanning both SPECT and PET products) and 8 radiotherapeutic products (3 product categories) in Japan. Additionally, PDRadiopharma and PeptiDream are developing a broad pipeline of radiotherapeutics and radiodiagnostics for both the Japan and global markets. For more information about PDRadiopharma, please visit www.pdradiopharma.com/en/

Inquiries:

Curium
Camilla Campell
VP, Head of Global Communications
Email: communications@curiumpharma.com
Website: www.curiumpharma.com

PeptiDream Inc.
Contact: Yuko Okimoto, IR & Corporate Communications
Email: info@peptidream.com
Website: https://www.peptidream.com/en/
X: https://x.com/PeptidreamInc
LinkedIn: https://www.linkedin.com/company/peptidream

PDRadiopharma Inc.
Contact: Noriko Tanaka, General Affairs
Email: s-info-hq@pdradiopharma.com