NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals, and Curadh MTR Inc. (Curadh), a global MTR focused clinical, research and advisory organization, today announced the signing of a strategic long term supply agreement for the therapeutic radioisotope non-carrier added (n.c.a.) actinium-225 (Ac-225).
Under the terms of the agreement, NorthStar will supply its high purity, n.c.a. Ac-225 to Curadh for use in its pioneering molecularly targeted radiation (MTR) programs for the treatment of common lethal tumors.
“We are very pleased to enter this supply agreement for n.c.a. Ac-225 with Curadh,” said Frank Scholz, Ph.D., President and Chief Executive Officer of NorthStar Medical Radioisotopes. “As a company at the forefront of U.S. radioisotope production, we are applying our proven electron accelerator technology expertise with molybdenum-99 (Mo-99) and copper-67 (Cu-67) to rapidly advance large-scale production of n.c.a. Ac-225 for use in radiopharmaceutical therapy (RPT). Progress on our dedicated, state-of-the-art Actinium-225 Production facility is on schedule. The electron accelerator has been installed and initial production of radiochemical grade Ac-225 is planned in H2 2024. NorthStar expects to submit a Drug Master File to the FDA as quickly as possible thereafter, which, upon acceptance, will allow for the production of cGMP grade Ac-225. This supply agreement for n.c.a. Ac-225 with Curadh is an important step in helping to provide molecularly targeted radiation therapies for patients with cancer, and we look forward to working with them going forward.”
“Molecularly targeted radiation is an exciting new field in oncology enabling us to deliver ‘systemic radiotherapy’ to patients with metastatic disease. Curadh has a highly experienced MTR team which is dedicated to accelerating the development of new MTR treatments for solid tumors,” said Dr. Alison Armor, MD, FRCR, FRCP, Chief Executive Officer and founder of Curadh. “The isotope used is very important, depending on the tumor, and the development of Ac-225 based therapies has traditionally been constrained by the limited supply of this key isotope. We look forward to working with NorthStar to supply n.c.a. Ac-225 for our program needs, to complement the suite of services that we offer our clients.”
About Actinium-225
Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes 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 have been constrained by chronic short supply due to limitations of current production technology. NorthStar 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 therapy products. 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.
About Curadh MTR
Curadh is dedicated to improving and accelerating the development of molecularly targeted radiation therapies for solid tumors under the leadership of its founder, Dr Alison Armour, who developed PSMA617 for Endocyte, later approved as Pluvicto.
Curadh Clinical has an experienced team focused exclusively on the new field of molecularly targeted radiation (MTR), with experts in all stages of oncology drug development and a track record of successful MTR development. It provides global, preclinical, clinical and regulatory consultancy as well as early clinical trial services to biotech and pharma companies in the MTR space who are seeking to transition from pre-clinical to early phase clinical development.
Curadh has successfully advanced its own discovery focus of next generation targets of solid tumours to the stage where the company is looking to form strategic partnerships to develop its own novel molecules and targets as well as those of its partners.
About NorthStar Medical Radioisotopes, LLC
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company focused on advancing patient care by providing diagnostic and therapeutic radioisotopes, novel radiopharmaceuticals and customized radiopharmaceutical development services. Its proven management team and state-of-the-art, environmentally preferable and non-uranium based technologies have made it an emerging leader at the forefront of U.S. medical radioisotope and radiopharmaceutical production. NorthStar’s molybdenum-99 (Mo-99) program is the sole source of domestic Mo-99, used to generate the standard-of-care diagnostic imaging radioisotope for assessing heart disease and cancer. It is expanding its industry-leading position in the growing area of therapeutic radioisotopes, used in targeted radiopharmaceutical therapy to treat cancer and other serious diseases, and is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67). NorthStar’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO/CMO) services unit will provide customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercialization programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.
