NorthStar Medical Radioisotopes will supply Actinium-225 to biotechnology company Aktis Oncology for the development of new targeted alpha radiopharmaceuticals to treat a range of solid tumors.

A high-energy alpha-emitting radioisotope, Ac-225 is used in targeted radiopharmaceutical therapy, which combines select molecules with therapeutic radioisotopes to directly target and destroy cancer cells with radiation. It does this by breaking double strand DNA in the cells to overcome acquired resistance to chemotherapy.

Aktis Oncology is creating precision targeting molecules to ensure Ac-225 directly hits the tumor. NorthStar will use its electron accelerator technology to produce high-purity noncarrier-added Ac-225, which Aktis will use to create targeted radioconjugates to treat cancers with limited treatment options, including breast, lung, colorectal, liver and bladder cancers.
Aktis is also partnering with Niowave Inc., and TerraPower LLC for preclinical, clinical, and commercial supplies of Ac-225. "We believe these foundational relationships with such high-quality suppliers will ensure timely and efficient progression of our programs and ultimately, enable patient access to potentially lifesaving therapies,” said Matthew Roden, president and chief executive officer of Aktis Oncology, in a statement.

Niowave builds and operates superconducting electron accelerators to produce Ac-225, while TerraPower relies on a Thorium-229 generator. All three agreements are expected to build up Aktis’ supply access, radiomanufacturing and distribution capabilities.

NorthStar aims to be the first commercial-scale producer of Ac-225 and will use its electron accelerator technology to generate a form that is free of long-lived radioactive contaminants and byproducts, reducing regulatory and waste management challenges.

It recently struck another agreement with Clovis Oncology, which will use its Ac-225 supply to radiolabel its peptide-targeted radionuclide therapeutic candidate, FAP-2286, which targets fibroblast activation protein (FAP). FAP has shown potential as a theranostic target for many different types of tumors.

It also made other agreements earlier this year with Curie Therapeutics; and Convergent.

NorthStar is currently building a state-of-the-art Actinium-225 Production facility and plans to begin production in 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,” said Stephen Merrick, chief executive officer of NorthStar Medical Radioisotopes.

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