August 26, 2022 — NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, today announced the signing of a long-term supply agreement for the therapeutic radioisotope actinium-225 (Ac-225) with Aktis Oncology, Inc. Under terms of the agreement, NorthStar will be a major supplier of high purity non-carrier-added (n.c.a.) Ac-225 to Aktis. Aktis will use NorthStar’s Ac-225 to advance development of its proprietary tumor-targeting agents intended to deliver transformative efficacy for patients with solid tumors.
Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of targeted radiopharmaceutical therapy, which combines select molecules with therapeutic radioisotopes to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while its half-life limits unwanted radioactivity in patients. Clinical research and commercial use of Ac-225 have been constrained by chronic short supply due to limitations of current production technology. NorthStar is positioned to be the first commercial-scale producer of Ac-225 for advancing clinical research and commercial radiopharmaceutical therapy products. The Company 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. Such contaminants pose regulatory and waste management challenges for pharmaceutical companies, hospitals, and health systems.
“We are very pleased to enter this Ac-225 supply agreement with Aktis Oncology, and we look forward to working with them in their efforts to provide targeted alpha radiopharmaceuticals to treat patients with cancer,” Stephen Merrick, Chief Executive Officer of NorthStar Medical Radioisotopes. “NorthStar is poised to be the first commercial-scale producer of Ac-225, utilizing our n.c.a. Ac-225 production technology that is environmentally preferable and non-uranium based, utilizing state-of-the-art electron beam accelerator production that provides increased capacity and scheduling flexibility. Construction of our dedicated Actinium-225 Production facility is well underway, 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.”
“Aktis Oncology is harnessing the power of targeted alpha radiotherapy to treat a broad range of cancers, including breast, lung, colorectal, bladder, and liver cancers,” said Matthew Roden, PhD, Aktis Oncology President and Chief Executive Officer. “Aktis is pleased have NorthStar as an experienced and reliable partner in innovative, accelerator-based radioisotope production technology as our programs advance towards the clinic. We look forward to working with NorthStar to supply Ac-225 to deliver highly transformative treatments for patients with cancer.”
For more information: www.northstarnm.com
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