ITM Isotopen Technologien München (ITM) is setting its sights on establishing a stable supply and increasing testing of no-carrier-added (n.c.a.) Lutetium-177 through its development this month of two North American partnerships.

Isotope Technologies Garching (ITG), a subsidiary of the German-based network of specialized radiopharmaceutical companies, has signed a Memorandum of Understanding with Canada-based nuclear power enterprise, Bruce Power, to collaborate in the production of n.c.a. Lutetium-177 through 2064. In addition, it has agreed to supply the medical radioisotope on a long-term basis to the Indiana-based company, Endocyte, for its 3 VISION trial in the treatment of advanced prostate cancer and will continue to do so through 2035.

“No-Carrier-Added Lutetium-177 supplied by ITM globally is the isotope that is expected to see the most significant growth in market demand in the near future for use in targeted therapeutic treatments,” James Scongack, vice president of corporate affairs and environment at Bruce Power, told HCB News. “ITG uses a proprietary process for producing the no-carrier-added Lutetium-177 which is ideal from a Bruce Power operational perspective.”

A radiopharmaceutical precursor, Lutetium-177 has been evaluated in targeted radionuclide therapy to treat diseases such as neuroendocrine tumors and prostate cancer by destroying cancer cells while sparing healthy ones.

Supplied globally by ITM under the brand name, EndolucinBeta, n.c.a. Lutetium-177 is composed of no metastable, long-lived Lutetium-177 impurities, enabling it to provide the highest specific activity of all forms of the Lutetium-177 radioisotope. Its level of radionuclidic purity allows for more effective and economic waste management as well as greater environmental sustainability and the best preconditions for the radiolabeling of biomolecules.

Under the its agreement with Bruce Power, ITM will oversee development, processing and global distribution of the radiopharmaceutical, which will be produced by Bruce Power’s CANDU reactors which, according to Scongack, are ideal for isotope production due to their design and operational characteristics.

With Endocyte, ITG will supply 100 percent of the Lutetium-177 required for the phase 3 VISION trial, aided by ITG which will provide at least 50 percent and up to 100 percent of commercial supply for requests made by Endocyte.

Endocyte will pay €5 million ($5.8 million) upfront, which will be used to further expand ITG’s worldwide manufacturing capacity for Lutetium-177.

ITM CEO Steffen Schuster says that both agreements will aid in the growth of large-scale radiopharmaceutical development, which is limited by the short half-lives of radioligands, making them less accessible than other cancer treatments. He adds that unlicensed radiopharmaceuticals such as n.c.a. Lutetium-177 have been highly efficient in treating patients with progressive cancers on compassionate use basis for several years, with few side effects.

“Successful treatments were sometimes reported as case-studies or retrospective studies, but systematic prospective data from Phase I-III clinical trials were rarely generated. This situation has changed in recent years due to treatment success of targeted radionuclide therapy,” he told HCB News. “New targets in cancer cells such as gastrin-releasing peptide receptors, integrins, PSMA and melanocyte-stimulating hormone receptors may provide additional opportunities for a broader range of cancer types to be treated with medical radionuclides.”

No financial details in the ITM-Bruce Power agreement were disclosed. Additional terms of the ITM-Endocyte agreement were also not specified.