Curium and PDRadiopharma Collaborate to Advance PSMA-Targeting Theranostics in Japan

Curium (搜索)搜索该词条 and PDRadiopharma (搜索)搜索该词条, a subsidiary of PeptiDream查看公司主页, have announced a collaboration to support the clinical development, regulatory filing, and commercialization of PSMA (搜索)搜索该靶点-targeting theranostics 177Lu-PSMA-I&T查看药品详情 and 64Cu-PSMA-I&T查看药品详情 in Japan. This partnership seeks to bring new diagnostic and therapeutic options to patients with prostate cancer (搜索)搜索该疾病 in Japan, addressing a significant unmet need in the region.

Under the agreement, Curium (搜索)搜索该词条 will continue to lead global development of the agents while PDRadiopharma (搜索)搜索该词条 will spearhead regulatory filing, manufacturing, commercialization, and distribution activities within Japan. Curium will also support PDRadiopharma in establishing manufacturing capabilities in Japan.

Patrick C. Reid, president and CEO of PeptiDream查看公司主页, stated, "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer...we are thrilled to be able to accelerate those efforts by partnering with Curium (搜索)搜索该词条 to bring their highly promising prostate cancer (搜索)搜索该疾病 targeting radiopharmaceuticals to patients in Japan."

Ongoing Clinical Trials

ECLIPSE Trial (177Lu-PSMA-I&T查看药品详情): The Phase 3 ECLIPSE trial (NCT05204927查看临床试验) is evaluating the safety and efficacy of 177Lu-PSMA-I&T compared to standard-of-care hormone therapy in patients with metastatic castration-resistant prostate cancer (搜索)搜索该疾病 (mCRPC). The open-label, global trial has enrolled over 400 patients across 51 sites in the US and Europe. Patients are randomized 2:1 to receive either 177Lu-PSMA-I&T or hormone therapy (abiraterone with prednisone or enzalutamide). The primary endpoint is radiographic progression-free survival, assessed for up to 34 weeks. Secondary endpoints include overall survival, progression-free survival, PSA reduction rate (≥50%), and quality-of-life measures. Final study completion is anticipated in June 2029.

SOLAR Trials (64Cu-PSMA-I&T查看药品详情): The diagnostic performance of 64Cu-PSMA-I&T is being assessed in two Phase 3 trials: SOLAR RECUR (NCT06235099查看临床试验) and SOLAR STAGE (NCT06235151查看临床试验). These multicenter trials have enrolled patients across 50 sites in the US and over 30 sites in Europe.

• SOLAR RECUR: This trial is evaluating 64Cu-PSMA-I&T in patients with suspected biochemically recurrent prostate cancer after radical prostatectomy or radiation therapy. The prospective, open-label study plans to enroll approximately 200 patients. Co-primary endpoints are patient-level correct detection rate (CDR) and region-level correct localization rate (CLR). Secondary outcome measures include CDR and CLR by PSA level and histopathology status, inter- and intra-reader agreement, and adverse event incidence.
• SOLAR STAGE: This trial is assessing 64Cu-PSMA-I&T in patients with newly diagnosed unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer planning to undergo radical prostatectomy with pelvic lymph node dissection. The study aims to enroll 323 patients who will receive an 8 mCi intravenous dose of 64Cu-PSMA-I&T prior to PET/CT imaging. The primary endpoints are sensitivity and specificity. Secondary endpoints include inter- and intra-reader agreement and adverse event incidence.

Completion of both SOLAR RECUR and SOLAR STAGE trials is expected in July 2025.

These Phase 3 studies build upon positive results from the Phase 1/2 SOLAR trial (NCT05653856查看临床试验), which met its co-primary endpoints of patient-level CDR and region-level CLR in patients with metastatic prostate cancer (搜索)搜索该疾病 in August 2023. The trial enrolled 26 patients across US clinical trial sites.