- 61Cu-NuriPro™ detected more lesions up to 4 hours post-administration in 50% of patients, not visualized by 18F-piflufolastat PET1,2
- Dosimetry data highlight favorable tumor-to-background ratio with 61Cu-NuriPro™
- 61Cu-NuriPro™’s 3.3 hours half-life allows for greater distribution range and later imaging after administration
- Data presented on Monday, June 23 by Principal Investigator Dr. Gary Ulaner, MD, PhD at the SNMMI 2025 Annual Meeting in New Orleans
Basel, Switzerland, June 24, 2025 – NUCLIDIUM AG a clinical-stage radiopharmaceutical company developing copper-based theranostics, today announced 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. 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.
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 program2,3,4,5,6. 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.
About NUCLIDIUM
Nuclidium AG is a clinical-stage biotechnology company pioneering the development of next-generation copper-based radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging copper isotopes — Copper-61 for diagnostics and Copper-67 for therapeutics — Nuclidium is creating a differentiated platform with the potential to overcome existing limitations in radiotheranostics. With operations in Switzerland and Germany, the company combines innovative chemistry, deep clinical expertise, and strategic manufacturing capabilities to deliver scalable, accessible, and clinically superior theranostic solutions to patients worldwide. Nuclidium is committed to expanding the reach and efficacy of radiotheranostics, including addressing critical unmet medical needs in oncology and women’s health.
For more information, please contact:
NUCLIDIUM
Leila Jaafar, CEO
Email: info@nuclidium.com
Investor/Media Contact NUCLIDIUM
Trophic Communications
Stephanie May
Email: nuclidium@trophic.eu
Phone: +49 171 1855682
1 European Medicines Agency. Pylclari - International non-proprietary name: piflufolastat (18F), Assessment report-EMA/CHMP/279917/2023, https://www.ema.europa.eu/en/documents/assessment-report/pylclari-epar-public-assessment-report_en.pdf, accessed 20 June 2025
2 FDA Approves Pluvicto/Locametz for Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. May 2022;63(5):13n.
3 Keam SJ. Piflufolastat F 18: Diagnostic First Approval. Mol Diagn Ther. Sep 2021;25(5):647-656. doi:10.1007/s40291-021-00548-0
4 Heo YA, Jadvar H, Calais J, et al. Flotufolastat F 18: Diagnostic First Approval Appropriate Use Criteria for Prostate-Specific Membrane Antigen PET Imaging. Mol Diagn Ther. Jul 13; Jan 2023;63(1):59-68. doi:10.1007/s40291-023-00665-y10.2967/jnumed.121.263262
5 Hennrich U, Eder M. [(68)Ga]Ga-PSMA-11: The First FDA-Approved (68)Ga-Radiopharmaceutical for PET Imaging of Prostate Cancer. Pharmaceuticals (Basel). Jul 23 2021;14(8)doi:10.3390/ph14080713
6 Basaco Bernabeu T, Fani M, et al. 61Cu-PSMA–Targeted PET for Prostate Cancer: From Radiotracer Development to First-in-Human Imaging. JNM. Sep 2024, 65 (9) 1427-1434. doi: https://doi.org/10.2967/jnumed.123.267126
