NUCLIDIUM has achieved a significant milestone in prostate cancer imaging with the successful administration of its copper-based radiotracer 61Cu-NODAGA-PSMA I&T (61Cu-NuriPro) to the first patient in a phase 1 clinical trial. The investigator-initiated, non-randomized study at Hoag Memorial Hospital Presbyterian in Newport Beach, California, is comparing the diagnostic performance of the experimental agent against the FDA-approved 18F-piflufolastat in patients with PSMA-positive prostate cancer.
Enhanced Detection Capabilities Demonstrated
Principal investigator Gary Ulaner, MD, PhD, director of molecular imaging and therapy at Hoag Memorial Hospital Presbyterian, reported promising initial results from the first patient. "The first patient has not experienced any adverse events so far, and the scan with 61Cu-NuriPro showed more osseous lesions than 18F-piflufolastat at 1 hour post-injection," Ulaner stated. "Also, the PET scans with 61Cu-NuriPro identified more osseous lesions at 2 and 4 hours compared to 1 hour post-injection."
These preliminary clinical findings align with preclinical results and suggest the potential for superior imaging performance of the copper-based radiotracer. The enhanced detection capability over extended time periods could prove particularly valuable for identifying smaller metastases that might be missed with current imaging approaches.
Manufacturing and Distribution Advantages
The 61Cu-based radiotracer offers several potential advantages over existing imaging modalities. With a 3.3-hour half-life compared to the 1-2 hour half-life of most current molecular imaging agents, 61Cu-NODAGA-PSMA I&T allows for greater distribution range following production. The agent can be manufactured at room temperature, enabling on-demand preparation with a simplified workflow that requires reduced laboratory equipment.
The diagnostic tracers are manufactured by PharmaLogic Holdings in Los Angeles and delivered to Hoag in ready-to-inject form. NUCLIDIUM entered into a collaboration agreement with PharmaLogic in 2023, providing scientific know-how, proprietary technology, and raw materials to enable safe and accurate production of high-quality 61Cu-radionuclides and radiopharmaceuticals.
Theranostic Pipeline Development
NUCLIDIUM's approach centers on developing a true theranostic pipeline using copper's unique properties. The therapeutic counterpart, 67Cu-NODAGA-PSMA I&T (67Cu-NuriPro), is currently completing its preclinical program with a phase 1 trial planned to start in 2025. Upon successful completion of the current phase 1 study, NUCLIDIUM plans to initiate a phase 1/2 trial evaluating both the imaging agent and the therapeutic candidate together.
"Copper's unique properties allow us to establish the first true theranostic pipeline that can achieve more accurate staging of the individual patient and more precise treatment of their disease," explained Leila Jaafar, PhD, CEO and co-founder of NUCLIDIUM. "Our NuriPro diagnostic's imaging profile can overcome both detection and production challenges for physicians and patients living with prostate cancer."
Clinical Context and Significance
Ulaner emphasized the clinical importance of the research, noting that "prostate cancer remains the most frequently diagnosed cancer and the second most common cause of cancer death in American men. Rapid and precise diagnosis is essential for effective treatment." The study aims to assess the clinical safety of 61Cu-NuriPro while comparing its diagnostic performance with established PSMA-targeting radiotracers.
NUCLIDIUM has also established strategic partnerships to advance its copper-based radiopharmaceutical program. In May 2024, the company announced a strategic partnership with Guerbet to support the clinical development of its copper-based radiotheranostics, complementing its existing collaboration with PharmaLogic Holdings.
The company's preclinical studies have shown that copper-based candidates demonstrate greater imaging capacity with less toxicity compared to existing approaches, providing the foundation for the current clinical investigation and future theranostic development.
