NorthStar Medical Radioisotopes and Curadh MTR Enter Strategic Collaboration Agreement for Development and Production of Actinium-225 (Ac-225)-based Therapeutic Radiopharmaceuticals for Treatment of Primary and Metastatic Solid Tumors

• Collaboration expands August 2023 agreement under which NorthStar’s environmentally preferable, high purity n.c.a. Ac-225 will be used in Curadh’s molecularly targeted radiation (MTR) programs for treatment of solid tumors.
• Under the new agreement, NorthStar will manufacture and distribute patient doses for ongoing Curadh Ac-225 clinical studies and provide Ac-225 for commercial use upon NorthStar’s submission of a Type II Drug Master File (DMF) to the FDA.
• The collaboration also provides that NorthStar will manufacture and distribute patient doses of Curadh diagnostic and therapeutic isotopes of future interest.

BELOIT, Wis. & CHESTER SPRINGS, Pa.--(BUSINESS WIRE)-- NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, and Curadh MTR Inc. (Curadh), a global MTR-focused clinical, research and advisory organization, today announced a long-term strategic collaboration to develop and produce novel radiopharmaceuticals for the diagnosis and treatment of solid tumor cancers.

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Under the agreement, NorthStar will support the development of select Curadh radiopharmaceutical targets by preparing and distributing Curadh patient doses of n.c.a. Ac-225 for its ongoing clinical studies and, upon approval, may manufacture and supply radiopharmaceuticals for commercial use. The new agreement also provides Curadh access to NorthStar’s integrated radiopharmaceutical development and manufacturing organization to support development and commercialization of future radiopharmaceutical diagnostic and therapeutic agents.

“This collaboration leverages NorthStar’s advanced technology and development and manufacturing expertise to advance Curadh’s innovative radiopharmaceutical candidates to benefit patients with cancer,” said Frank Scholz, Ph.D., Chief Executive Officer of NorthStar Medical Radioisotopes.

NorthStar will become one of the first commercial-scale producers of n.c.a. Ac-225, using the advanced, environmentally preferable electron accelerator technology that today supports routine production of the therapeutic radioisotope copper-67 (Cu-67). “NorthStar’s radiopharmaceutical expertise,” continued Scholz, “coupled with our manufacturing expertise and experience, allows us to offer a uniquely powerful ‘end-to-end’ support package to our development collaborators. Build-out of our 52,000 square foot CDMO facility is on schedule, and we expect it to be in full operation by January 2025, pending appropriate licensure and regulatory approvals.”

“Our focus is on advancing new MTR treatments for patients with primary and metastatic solid tumors, “ said Dr. Alison Armor, MD, FRCR, FRCP, Chief Executive Officer and founder of Curadh. “Working with NorthStar, a proven leader in nuclear medicine innovation and production, we believe that together we can ensure timely and efficient progression of our programs towards the clinic, and give patients broader access to potentially life-saving therapies.”

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.

For more information, visit: www.curadhmtr.com.

About NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.

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