NUCLIDIUM has announced the commencement of a Phase I clinical trial for its radiotracer candidate, ⁶¹Cu-NuriPro, designed as a diagnostic and disease-staging agent for prostate cancer.
The first patient has been successfully imaged, marking a milestone in the development of this copper-based radiopharmaceutical.
⁶¹Cu-NuriPro is part of NUCLIDIUM's NuriPro programme, which targets Prostate Specific Membrane Antigen (PSMA), a recognised biomarker for certain types of prostate cancer. This marks the first entry of NUCLIDIUM's copper-based radiopharmaceutical pipeline into clinical evaluation.
Its theranostic counterpart, ⁶⁷Cu-NuriPro, is anticipated to enter a Phase I clinical study in 2025 after completing preclinical development.
The non-randomised Phase I trial of ⁶¹Cu-NuriPro is being conducted at Hoag Memorial Hospital Presbyterian in Newport Beach, California.
It aims to assess the safety and efficacy of ⁶¹Cu-NuriPro compared to an 18F-based FDA-approved PSMA-targeting radiotracer.
The candidate's longer half-life of 3.3 hours could offer substantial distribution advantages post-production, potentially improving cancer imaging.
NUCLIDIUM co-founder and CEO Leila Jaafar said: “With the initiation of this first trial, we have begun building the clinical data that aims to demonstrate the differentiation of our radiopharmaceutical approach after our copper-based candidates have shown greater imaging capacity with less toxicity in pre-clinical studies. 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.
“Our NuriPro diagnostic’s imaging profile can overcome both detection and production challenges for physicians and patients living with prostate cancer and we look forward to further exploring its potential.”
Upon successful completion of this trial, NUCLIDIUM plans to progress the NuriPro programme into a combined Phase I/II theranostic trial to evaluate both ⁶¹Cu-based imaging candidate and ⁶⁷Cu-based therapeutic candidate.
The ease of manufacturing ⁶¹Cu-NuriPro at room temperature may streamline on-demand preparation and application processes while enabling delayed imaging for detecting smaller metastases.
PharmaLogic Holdings manufactures the diagnostic tracers in Los Angeles, California, delivering them to Hoag Hospital in ready-to-inject form.
NUCLIDIUM's collaboration with PharmaLogic, initiated in 2023, involves sharing scientific expertise, proprietary technology, and raw materials for producing ⁶¹Cu-radionuclides and radiopharmaceuticals.
In May 2024, NUCLIDIUM formed a strategic partnership with Guerbet to further develop its copper-based radiopharmaceuticals.
This alliance grants NUCLIDIUM access to Guerbet's expertise in diagnostic imaging and clinical trials, supporting NUCLIDIUM's path towards commercialising its theranostic products.
