177Lu-PSMA-I&T

Collaboration to include the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T Builds on long-standing relationship between the two companies In Japan around 90,000 new cases of prostate cancer are diagnosed each year Oct. 01, 2024 -- Curium, a world leader in nuclear medicine, announced today that it has entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T. The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair. Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology. Patrick C. Reid, President & CEO of PeptiDream commented: “Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these powerful targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their highly promising prostate cancer targeting radiopharmaceuticals to patients in Japan.” Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: “We are excited to partner with Curium in the development of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T, highly promising products for both the diagnosis and treatment of PSMA-expressing prostate cancer. We look forward to working with Curium to deliver these much-needed agents to prostate cancer patients in Japan as quickly as possible.” Chaitanya Tatineni, Curium’s CEO International Markets commented: “As a global innovator in the field of radiopharmaceuticals with a promising late-stage oncology pipeline, Curium is delighted to partner with PDRadiopharma which has more than four decades of experience in Japan. Curium and PDRadiopharma plan to leverage their complementary strengths to accelerate the development of innovative products for the benefit of prostate cancer patients in Japan.” Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases, with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies. 177Lu-PSMA-I&T, a PSMA inhibitor conjugated with the radioisotope Lutetium 177, is currently being tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). ECLIPSE is a multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer. The ECLIPSE trial enrolled over 400 patients, across 51 trial sites in the United States and Europe. 64Cu-PSMA-I&T PET is currently being investigated in 2 multicenter Phase 3 trials; SOLAR RECUR testing the diagnostic performance in men with biochemical recurrence of prostate cancer (ClinicalTrials.gov identifier NCT06235099) and SOLAR STAGE testing the diagnostic performance in men with newly diagnosed unfavorable intermediate- to high-risk prostate cancer (ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer. PSMA-targeted PET/CT imaging is increasingly emerging as a highly sensitive method for detection of locally recurrent or metastatic lesions in the context of biochemical recurrence and for localization of primary prostate cancer. Curium and PDRadiopharma have a long-standing relationship in the radiopharmaceutical field. PeptiDream Inc. (Tokyo Stock Exchange Prime Market 4587) is leading the translation of macrocyclic peptides into a whole new class of innovative medicines to address unmet medical needs and improve the quality of life of patients worldwide. In its radiopharmaceutical business, through its wholly-owned subsidiary PDRadiopharma, PeptiDream markets and sells a number of approved radiopharmaceuticals and radiodiagnostics in Japan, as well as leveraging its proprietary Peptide Discovery Platform System (PDPS) technology to discover and develop a deep pipeline of innovative targeted radiotherapeutics and radiodiagnostics, spanning both wholly-owned internal programs and globally partnered programs. In its non-radiopharmaceutical business, PeptiDream is similarly leveraging PDPS to discover and develop a broad and diverse pipeline of investigational peptide therapeutics, peptide drug conjugates (PDC) and multi-functional peptide conjugates (MPC) across an extensive global network of discovery and development partners. PeptiDream is headquartered in Kawasaki, Japan. For more information about our company, science and pipeline, please visit www.peptidream.com/en PDRadiopharma, a wholly-owned subsidiary of PeptiDream since 2022, has been providing high-quality radiopharmaceuticals through the research and development, manufacturing, regulatory and sales as a forerunner in the field in radiopharmaceuticals, since it started its business in 1968. PDRadiopharma currently markets 21 radiodiagnostic products (spanning both SPECT and PET products) and 8 radiotherapeutic products (3 product categories) in Japan. Additionally, PDRadiopharma and PeptiDream are developing a broad pipeline of radiotherapeutics and radiodiagnostics for both the Japan and global markets. For more information about PDRadiopharma, please visit www.pdradiopharma.com/en 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. 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ST. LOUIS, May 12, 2022 (GLOBE NEWSWIRE) -- Curium confirmed today no supply challenges of 177Lu-PSMA-I&T for the Phase 3 ECLIPSE clinical trial (NCT05204927), evaluating Lutetium 177Lu-PSMA-I&T treatment compared to the standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer (mCRPC). Curium continues to provide clinical trial supply, and enroll patients in the ECLIPSE clinical trial with no disruptions. “Earlier this month we announced significant progress in our ECLIPSE clinical trial. We are enrolling eligible patients into our study of 177Lu-PSMA-I&T without disruption, which is a testament to our surety of supply. Reliability is a core competency for Curium and is fundamental to fulfilling our purpose of redefining the experience of cancer through our trusted legacy in nuclear medicine,” said Renaud Dehareng, Curium’s Group CEO. “We are thrilled to be able to reliably support our patients, investigators and clinical trial sites,” said Sakir Mutevelic, MD, Curium’s Chief Medical Officer. “We remain committed to patients with metastatic castration-resistant prostate cancer.” For more information about the ECLIPSE Trial, visit Curium’s Clinical Trial website https://www.curiumpharma.com/clinical-trials/ or contact Curium’s Clinical Trial team directly at ECLIPSE@curiumpharma.com with questions or to locate a clinical trial site near you. About Curium Curium is the world’s largest nuclear medicine company. 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 curiumpharma.com.