[18F]DCFPyL

Basel, Switzerland, 21 October 2024 – NUCLIDIUM today announced 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. 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. 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. Gary Ulaner, MD, PhD, Director of Molecular Imaging and Therapy at Hoag Memorial Hospital Presbyterian and Principal Investigator of the trial added: “Prostate cancer remains the most frequently diagnosed cancer and the second most common cause of cancer death in American men.[v] Rapid and precise diagnosis is essential for effective treatment. Our study aims to assess the clinical safety of 61Cu-NuriProTM and compare its diagnostic performance with an FDA-approved PSMA-targeting radiotracer. The first patient has not experienced any adverse events so far and the scan with 61Cu-NuriProTM showed more osseous lesions than 18F-piflufolastat, at 1 hour post-injection. Also, the PET scans with 61Cu-NuriProTM identified more osseous lesions at 2 and 4 hours compared to 1 hour post-injection. These preliminary clinical findings are in accordance with the preclinical results and underline the potential, favorable imaging performance of 61Cu-NuriProTM.” “With the initiation of this first trial, we have begun building the clinical data that aiming 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,” said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM. “Our NuriProTM 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.” NUCLIDIUM is transforming precision oncology with its state-of-the-art copper-based radiopharmaceuticals, delivering unmatched accuracy and accessibility for targeted cancer treatment and diagnosis. Our innovative platform merges copper radiometals with targeted cancer molecules, speeding up the creation of new diagnostic and therapeutic solutions. This portfolio enhances efficacy and safety, offering cost-effective solutions for hospitals and patients. Our unique true theranostic model simplifies development, tackling manufacturing and distribution challenges to increase flexibility for medical providers. Our diverse, interdisciplinary team is dedicated to revolutionizing precision radio-oncology, significantly benefiting cancer patients. NUCLIDIUMLeila Jaafar, CEOEmail: info@nuclidium.com Investor/Media Contact NUCLIDIUMTrophic CommunicationsVeronika Máté, or Stephanie MayEmail: nuclidium@trophic.euPhone: +49 16090816161 Access PDF version [i] Keam SJ. Piflufolastat F 18: Diagnostic First Approval. Mol Diagn Ther. Sep 2021;25(5):647-656. doi:10.1007/s40291-021-00548-0 [ii] 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 [iii] FDA Approves Pluvicto/Locametz for Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. May 2022;63(5):13n. [iv] 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 [v] NIH: Cancer Stat Facts, https://seer.cancer.gov/statfacts/html/prost.html, accessed 15 October 2024.

PARIS, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that in Spain, PYLCLARI® is now available for patients with prostate cancer. PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings: Primary staging of patients with high-risk prostate cancer prior to initial curative therapyTo localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent Benoit Woessmer, PET Europe CEO at Curium commented, “The availability of PYLCLARI® in Spain is an important milestone for patients with prostate cancer and underscores our dedication to improving the choice of diagnostic PET radiopharmaceuticals. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are proud that the availability of PYLCLARI® continues to grow and now covers seven countries including Austria, France, Germany, Greece, Italy, the Netherlands, and Spain.” In Spain, prostate cancer is one of the most common cancers among men with around 30,000 new cases diagnosed nationwide every year. PYLCLARI® is being produced by Curium at two sites in Madrid and one site in Sevilla, ensuring timely and efficient distribution across the country. For more information about PYLCLARI®: www.pylclari.com In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018. About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross Bethell, VP, Head of Global CommunicationsCuriumcommunications@curiumpharma.com