NorthStar Medical Radioisotopes has installed an electron beam accelerator in a specially designed building to facilitate production of non-carrier-added actinium-225 (Ac-225).

Ac-225 is a high-energy alpha-emitting radioisotope being used in clinical studies for evaluating targeted radiopharmaceutical therapy. It combines specialized molecules with therapeutic radioisotopes to target, irradiate and destroy cancer cells, while sparing healthy tissue. It does this by breaking double strand DNA in the cells to overcome acquired resistance to chemotherapy.

But limitations in production technologies have reduced its availability for clinical trials, research and eventual commercialized products. Situated in the company’s Ac-225 production facility in Beloit, Wisconsin, the custom-built IBA RhodotronTT 300-HE (High Energy) electron beam accelerator is part of NorthStar’s plan to create a scalable, reliable and environmentally preferable source of Ac-225 for treating cancer and other serious diseases.
“With delivery and installation of this accelerator, progress on the new Ac-225 Production facility is well underway, with initial production of radiochemical grade Ac-225 planned for late 2023/early 2024. 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,” said Stephen Merrick, chief executive officer of NorthStar Medical Radioisotopes, in a statement.

The electron accelerator will produce high-purity, non-carrier-added Ac-225 that is free of long-lived radioactive byproducts associated with other production methods and that pose regulatory and waste management challenges for providers.

The company recently inked a deal to supply Ac-225 to biotechnology company Aktis Oncology for creating precision targeting molecules to ensure Ac-225 directly hits tumors, including breast, lung, colorectal, liver and bladder cancers.

It also has entered agreements with Clovis, Convergent, and Curie Therapeutics.

“NorthStar has n.c.a. Ac-225 production capacity to meet all customer needs from research through commercialization, and we can readily scale-up further as market demand increases,” said Merrick.

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