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NorthStar to support Curadh's Ac-225 clinical trials investigating solid tumor treatments

by John R. Fischer, Senior Reporter | January 08, 2024
Molecular Imaging
NorthStar will supply Ac-225 to Curadh for clinical trials.
NorthStar Medical Radioisotopes has agreed to be Curadh MTR’s supplier for ongoing Ac-225 clinical studies, supplying it with non-carrier-added patient doses of actinium-225 for research on potential diagnostic and therapeutic regimens for targeting solid tumors.

Curadh develops molecularly-targeted radiation (MTR) therapies for solid tumors and provides early clinical trial services to biotech and pharma companies to accelerate products from preclinical to early-phase clinical development stages.

Back in August, NorthStar agreed to supply its environmentally preferable, high purity n.c.a. Ac-225 to Curadh for its MTR programs to treat solid tumors. Under this expanded collaboration, it will manufacture and distribute patient doses for Curadh’s clinical studies. Additionally, once NorthStar submits a Type II Drug Master File to the FDA, it may provide Curadh and other partners with Ac-225 for developing and commercializing future radiopharmaceutical diagnostic and therapeutic agents.
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“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 toward the clinic, and give patients broader access to potentially lifesaving therapies,” said Dr. Alison Armor, chief executive officer and founder of Curadh, in a statement.

Research using Ac-225 is currently underway for developing targeted alpha radiopharmaceuticals to treat breast, lung, colorectal, liver, brain, prostate, and bladder cancers, as well as nonsolid tumor cancers like leukemia. NorthStar is helping investigate treatment for some of these cancers with Ac-225 through other partnerships with Bayer, Aktis, and Clovis, among other companies.

NorthStar is currently building a 52,000-square-foot radiopharmaceutical contract development and manufacturing organization (CDMO) to provide partner companies like Curadh with a full range of customized radiopharmaceutical development and commercialization services, and to further its own radiopharmaceutical programs.

The CDMO will support the company in becoming one of the first commercial-scale producers of n.c.a. Ac-225, along with its advanced, environmentally preferable electron accelerator technology that today supports routine production of the therapeutic radioisotope copper-67.

Curadh was formed by Dr. Alison Armour, who developed PSMA617 for Endocyte, later approved as Pluvicto. The company is currently looking to partner with NorthStar and other suppliers to develop its own novel molecules and targets as well as those of its partners.

It recently partnered with SHINE Technologies to be its supplier of non-carrier-added Lutetium-177 for future production of Terbium-161, which shows potential in theranostics, particularly in prostate cancer.

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