A Registrational Phase 2 clinical trial has been initiated for 64Cu-PSMA-I&T - a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells

PARIS, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Curium Group announced today that together with PeptiDream Inc. and PDRadiopharma Inc., a registrational Phase 2 clinical trial has been initiated in Japan for 64Cu-PSMA-I&T - a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma, a wholly owned subsidiary of PeptiDream, and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium's ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Renaud Dehareng, CEO of Curium Group commented: “Conducting these registrational 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 prostate cancer patients in Japan.”

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 targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan.”

About Prostate Cancer

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

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

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 64Cu-PSMA-I&T and177Lu-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 22 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
communications@curiumpharma.com

PeptiDream Inc.
Contact: Yuko Okimoto, IR & Public Affairs

Email: info@peptidream.com
Website: https://www.peptidream.com/en/
X: https://x.com/PeptidreamInc

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