NorthStar Medical Radioisotopes, LLC, a global developer and producer of radiopharmaceuticals used for therapeutic applications and medical imaging, and Nucleus RadioPharma, a contract development and manufacturing organization (CDMO) dedicated to building robust and reliable clinical and commercial supply chains for targeted radiotherapies, signed a supply agreement for the therapeutic radioisotope actinium-225 (Ac-225). NorthStar will supply its high purity, non-carrier added (n.c.a.) Ac-225 to Nucleus. Nucleus will use NorthStar’s Ac-225 for their customers’ radioligand pharmaceutical programs.

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. 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.

In a statement, NorthStar said that is positioned to be the first commercial-scale producer of n.c.a. Ac-225 and copper-67 (Cu-67) for advancing clinical research and commercial radiopharmaceutical therapies. 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.

“NorthStar is applying the same development expertise to rapidly advance large-scale production of n.c.a. Ac-225 that has positioned us at the forefront of U.S. radioisotope production as the only national commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99), and we previously announced successful production of Mo-99 using electron accelerator technology,” said Frank Scholz, President, and CEO of NorthStar Medical Radioisotopes. “Progress on our dedicated, state-of-the-art Actinium-225 Production facility is on schedule.” 

NorthStar expects to submit a Drug Master File to the FDA as quickly as possible, which, upon acceptance by the FDA, will allow NorthStar to provide cGMP grade Ac-225. 

“Nucleus was established to address the acute manufacturing scarcity of radionuclides and theranostics, which poses significant challenges to patient care and clinical trials for new radiopharmaceuticals,” said Charles Conroy, CEO of Nucleus. “We are pleased to work with NorthStar as an experienced and reliable partner in innovative, accelerator-based radioisotope production technology, and to using its n.c.a. Ac-225 to develop highly transformative treatments for patients with cancer.”