NorthStar Medical Radioisotopes has inked a supply agreement with pharmaceutical developer Clovis Oncology around the use of actinium-225.
A high-energy alpha-emitting radioisotope, Ac-225 is used in targeted radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes to directly target and destroy cancer cells with radiation.
Using NorthStar’s high-purity non-carrier-added Ac-225, Clovis plans to radiolabel its peptide-targeted radionuclide therapeutic candidate called FAP-2286, which targets fibroblast activation protein (FAP).
FAP has shown potential as a theranostic target for many different types of tumors, and Ac-225 can facilitate this type of treatment by providing sufficient radiation to eliminate cancer cells in localized areas, while its half-life limits unwanted radioactivity in patients.
“Our lead compound, FAP-2286, offers the potential to address a variety of solid tumors, as monotherapy and in combination, and working with NorthStar enables us to explore different modalities in this emerging class of cancer therapeutics,” said Patrick Mahaffy, president and CEO of Clovis Oncology, in a statement.
NorthStar aims to be the first commercial-scale producer of Ac-225 and will use its environmentally preferred electron accelerator technology to generate a form of it that is free of long-lived radioactive contaminants and byproducts associated with other production methods. This will reduce regulatory and waste management challenges.
In addition to Clovis, it has drawn up an Ac-225 supply agreement with Convergent Therapeutics
for its CONV01-α radiopharmaceutical agent for prostate cancer treatment; and with Curie Therapeutics
for its multimodal radiopharmaceutical platform, which will produce a novel class of radioligand actinium and lutetium conjugates that target solid tumors.
“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 commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99),” said Stephen Merrick, chief executive officer of NorthStar Medical Radioisotopes, in a statement.
NorthStar is currently building a state-of-the-art Actinium-225 Production facility and plans to begin production in late 2023. It will file and submit a Drug Master File in 2024 which, upon acceptance, will enable the company to start providing cGMP grade Ac-225.