On June 24, 2025 NUCLIDIUM AG a clinical-stage radiopharmaceutical company developing copper-based theranostics, reported positive data from the Phase 1 clinical trial evaluating the company’s novel PET imaging agent, 61Cu-NuriProTM (61Cu-NODAGA-PSMA I&T) in patients with metastatic prostate cancer (Press release, NUCLIDIUM, JUN 24, 2025, View Source [SID1234654086]). These data were presented on June 23 at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting in New Orleans by Dr. Gary Ulaner, MD, PhD, Director of Molecular Imaging and Therapy at Hoag Family Cancer Institute and Principal Investigator for the trial. Dr. Ulaner highlighted 61Cu-NuriPro’s favorable safety, dosimetry profile and imaging characteristics in Prostate Specific Membrane Antigen (PSMA)-positive prostate cancer patients.
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The Phase 1 trial conducted at Hoag Molecular Imaging and Therapy Clinic evaluated the safety, dosimetry and preliminary diagnostic efficacy of 61Cu-NuriProTM in patients with metastatic prostate cancer, and was compared to 18F-piflufolastat. 61Cu-NuriPro demonstrated a safety profile comparable to clinically established PSMA tracers with a favorable imaging performance. Notably, 61Cu-NuriPro PET visualized additional lesions in 50% of the patients which were not seen on the 18F-piflufolastat PET, with favorable tumor-to-background ratios. The number of detected lesions on the 61Cu-NuriPro PET increased up to 4 hours after administration, highlighting the diagnostic benefits of 61Cu’s 3.3-hour half-life and high positron yield.
"Accurate and reliable imaging remains essential in the management of prostate cancer. The Phase 1 results from 61Cu-NuriPro demonstrate not only a solid safety profile but also good imaging quality compared to standard-of-care," said Dr. Gary Ulaner, MD, PhD, Director of Molecular Imaging and Therapy at Hoag Memorial Hospital Presbyterian and Principal Investigator of the trial. "These early data suggest strong potential for improving diagnostic performance and patient outcomes."
Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM added "These results further validate our first-in-class copper theranostics platform and the clinical promise of 61Cu-NuriPro as a potential best-in-class diagnostic. We are dedicated to rapidly advancing our portfolio of copper-based theranostic agents for a broader range of cancers, with a focus on safety, sustainability, and scalability."
61Cu-NuriProTM (61Cu-NODAGA-PSMA I&T) is the diagnostic component of NUCLIDIUM’s PSMA-targeted NuriProTM program[2],[3],[4],[5],[6]. The company’s second diagnostic, 61Cu-TraceNET, targeting SSTR-positive tumors, is in a Phase 1/2a clinical trial in broncho-pulmonary, and gastroenterohepatic neuroendocrine tumors (BP- and GEP-NETs). The agent will be developed further for imaging in a subset of metastatic breast cancer patients. Clinical trials of two corresponding therapeutics, 67Cu-NuriPro and 67Cu-TraceNET, are expected to start enrollment in early 2026.