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NorthStar Medical Radioisotopes Announces Supply Agreement with Clovis Oncology for Therapeutic Radioisotope Actinium-225 (Ac-225)
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NorthStar Medical Radioisotopes has signed a long-term supply agreement with Clovis Oncology (CLVS) for actinium-225 (Ac-225), a therapeutic medical radioisotope. NorthStar will provide high-purity, non-carrier-added Ac-225 for Clovis's lead peptide-targeted therapeutic candidate, FAP-2286, which targets fibroblast activation protein across various tumors. The agreement aims to enhance the availability of targeted radiopharmaceutical therapies. NorthStar plans to begin Ac-225 production in late 2023 and submit a Drug Master File to the FDA in 2024.
Positive
Long-term supply agreement with Clovis Oncology for actinium-225 (Ac-225) enhances Clovis's development capabilities.
NorthStar positioned to be the first commercial-scale producer of Ac-225, meeting growing clinical demand.
Negative
Chronic short supply of Ac-225 has previously constrained clinical research and commercial use.
Dependence on future FDA approval for Drug Master File submission limits immediate operational capacity.
BELOIT, Wis.--(BUSINESS WIRE)--
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 with Clovis Oncology, Inc. (NASDAQ: CLVS) for the therapeutic medical radioisotope, actinium-225 (Ac-225). Under terms of the agreement, NorthStar will provide Clovis with its environmentally preferred, high purity non-carrier-added (n.c.a.) Ac-225. Clovis plans to use NorthStar’s Ac-225 to radiolabel its lead peptide-targeted radionuclide therapeutic candidate currently in development, FAP-2286, which targets fibroblast activation protein (FAP), a promising theranostic target with expression across many tumor types.
Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of targeted radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes, such as Ac-225, 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 are severely 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 products. NorthStar will use its environmentally preferred 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, which pose regulatory and waste management challenges for contract development and manufacturing organizations, hospitals, health systems and academic institutions.
“We are very pleased to enter this Ac-225 supply agreement with Clovis Oncology, and we look forward to working with them moving forward,” said Stephen Merrick, Chief Executive Officer of NorthStar Medical Radioisotopes. “Our companies share a vision of developing and delivering innovative technology and compounds to drive research and ensure clinical availability of targeted radiopharmaceutical therapies for patients with cancer. 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). Construction is now underway on our dedicated, state-of-the-art Actinium-225 Production facility, with initial production of radiochemical grade Ac-225 planned for late 2023, and a Drug Master File to be submitted in 2024, which, upon acceptance by the FDA, will allow NorthStar to provide cGMP grade Ac-225.”
“As part of Clovis Oncology’s commitment to developing peptide-targeted radionuclide therapeutic and imaging compounds, we recognize the importance of working with partners like NorthStar, whose knowledge and expertise can support our strategic goals,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “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.”
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company that manufactures and distributes diagnostic and therapeutic radiopharmaceuticals. The Company’s proprietary state-of-the-art technology and proven management team have propelled it to the forefront of U.S. medical radioisotope production as the sole domestic producer of the diagnostic imaging radioisotope molybdenum-99 (Mo-99). Mo-99 is used to generate technetium-99m (Tc-99m), the standard of care in diagnostic imaging to assess the extent and severity of heart disease and cancer. NorthStar’s unique Mo-99 production process is non-uranium based and environmentally friendly. NorthStar is expanding its industry-leading position in the emerging area of therapeutic radioisotopes, which are used in targeted radiopharmaceutical therapy to treat cancer, respiratory and other diseases. Using first-in-kind and environmentally-sound electron accelerator technology, NorthStar is poised to be the first commercial-scale producer of therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67). For more information about NorthStar’s comprehensive radiopharmaceutical portfolio, visit: www.northstarnm.com.
What is the significance of the supply agreement between NorthStar and Clovis Oncology?
The agreement ensures Clovis Oncology has access to actinium-225 (Ac-225) for its lead therapeutic candidate, enhancing its development pipeline.
When will NorthStar begin production of actinium-225 (Ac-225)?
NorthStar plans to start initial production of Ac-225 in late 2023.
What is FAP-2286 and how does it relate to Clovis and NorthStar's agreement?
FAP-2286 is Clovis's lead peptide-targeted radionuclide therapeutic candidate that targets fibroblast activation protein, and will utilize NorthStar's Ac-225.
What is actinium-225 (Ac-225) used for?
Ac-225 is used in targeted radiopharmaceutical therapy to deliver radiation directly to cancer cells.
How does NorthStar's production method for Ac-225 differ from traditional methods?
NorthStar uses environmentally preferred electron accelerator technology, which avoids long-lived radioactive contaminants.
