On October 21, 2024 NUCLIDIUM reported that the first patient has been successfully imaged in a phase 1 clinical trial evaluating the company’s radiotracer candidate as a safe and accurate diagnostic and disease-staging imaging agent in prostate cancer patients (Press release, NUCLIDIUM, OCT 21, 2024, View Source [SID1234647286]). 61Cu-NuriProTM (61Cu-NODAGA-PSMA I&T) is the diagnostic component of NUCLIDIUM’s NuriProTM program, binding specifically to Prostate Specific Membrane Antigen (PSMA). PSMA has evolved as an established biomarker for the diagnosis, staging, and treatment of patients suffering from certain types of prostate cancer.[i],[ii],[iii],[iv] 61Cu-NuriPro is the first candidate from the company’s innovative copper-based radiopharmaceutical pipeline to enter the clinic. Its theranostic counterpart, 67Cu-NuriProTM (67Cu-NODAGA-PSMA I&T), for the treatment of patients with certain types of prostate cancer, is currently completing its preclinical program. A phase 1 clinical study is planned to start in 2025.
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The investigator-initiated, non-randomized phase 1 trial is being conducted at Hoag Memorial Hospital Presbyterian in Newport Beach, California. It will evaluate the safety and effectiveness of the NuriProTM diagnostic candidate for imaging prostate cancer, compared to an 18F-based, FDA-approved PSMA-targeting radiotracer. The 61Cu-based candidate can potentially provide key benefits compared to other established radiotracers. With a 3.3-hour half-life, compared to the 1-to-2-hour half-life of most molecular imaging agents, it allows for a far greater distribution range following production. The company’s candidate can be easily manufactured at room temperature, enabling on-demand preparation and a simplified and easy-to-apply workflow with reduced need for laboratory equipment. It further enables delayed imaging, allowing for the detection of even the smallest metastases. Upon successful completion of the trial, NUCLIDIUM will advance the NuriProTM program into a Phase 1/2 theranostic clinical trial, evaluating both the 61Cu-based imaging agent alongside the 67Cu-based therapeutic candidate.
61Cu-NuriPro can be easily manufactured at room temperature, enabling on-demand preparation and a simplified as well as easy-to-apply workflow with reduced need for laboratory equipment. The diagnostic tracers are manufactured by PharmaLogic Holdings in Los Angeles, CA, and delivered to Hoag in a ready-to-inject form. NUCLIDIUM and PharmaLogic entered into a collaboration agreement in 2023, under which NUCLIDIUM provides PharmaLogic with scientific know-how, proprietary technology, and raw material enabling PharmaLogic to safely and accurately produce high-quality 61Cu-radionuclides and radiopharmaceuticals.