NorthStar Medical Radioisotopes, LLC (‘NorthStar’), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Curie Therapeutics Inc., a therapeutics company dedicated to transforming cancer care with precision radiopharmaceuticals, today announced the signing of a long-term priority access supply agreement for the therapeutic medical radioisotope actinium-225 (Ac-225).
Under the terms of the agreement, NorthStar will provide Curie Therapeutics with priority access to its electron accelerator-produced, n.c.a. Ac-225. Ac-225 is a high energy alpha-emitting radioisotope that, when combined with a targeting ligand, is of increasing interest for the treatment of solid tumors. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells. NorthStar will use its electron accelerator technology to produce n.c.a. Ac-225 that is free of long-lived radioactive contaminants and byproducts associated with other production methods, which pose regulatory and waste management challenges for hospitals and health systems.
“NorthStar is defining the supply chain for commercial-scale, reliable and environmentally preferred therapeutic radioisotope production. We are very excited to be partnering with Curie Therapeutics, an emerging leader in the development of precision radiopharmaceuticals,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technologies. Our company is positioned to be the first commercial-scale producer of Ac-225, utilizing our n.c.a. Ac-225 production technology which utilizes state-of-the-art electron beam accelerator production that provides increased capacity and scheduling flexibility. Construction of our dedicated Actinium-225 Production facility has begun, with initial production of radiochemical grade Ac-225 planned for late 2023. We expect to submit a Drug Master File to the FDA in 2024, which, upon acceptance, will allow NorthStar to provide cGMP grade Ac-225. We are very pleased to enter this Ac-225 supply agreement with Curie Therapeutics, and we look forward to a productive relationship as we both strive to ensure availability of targeted radiopharmaceutical therapy for patients with cancer.”
“Curie Therapeutics is broadly developing precision targeted radiopharmaceuticals to address high unmet needs in the treatment of solid tumors,” said Simon Read, Ph.D., Chief Executive Officer. “Curie Therapeutics’ ligands are engineered to achieve deep, homogeneous tumor distribution combined with rapid clearance. NorthStar is widely recognized for its leadership in cutting-edge radioisotope production technologies. This agreement secures our domestic sourcing of Ac-225, now and in the future, enabling us to pursue our mission to deliver innovative, safe and effective treatment of patients with solid tumor cancers.”