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ITM and Bruce Power Successfully Complete Feasibility Study

September 30, 2019 Off By BusinessWire

Key requirements met to start Ytterbium-176 irradiation at Bruce Power’s facilities for the production of ITM´s no-carrier-added Lutetium-177 for cancer therapy

GARCHING/MUNICH, Germany & TIVERTON, Canada–(BUSINESS WIRE)–ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and Bruce Power, a Canadian-based nuclear generator and isotope supplier, announced today that they have successfully completed a joint feasibility study at Bruce Power’s Nuclear Facilities for the irradiation of Ytterbium-176. Ytterbium‑176 is the source material of ITM´s medical radioisotope no-carrier-added (n.c.a.) Lutetium-177 (EndolucinBeta^®). The intermediate material to be generated at Bruce Power will be processed to the high purity medical radioisotope n.c.a. Lutetium-177 at ITM´s global network of radiopharmaceutical production facilities.

ITM and Bruce Power have come to the conclusion that Bruce Power and its partners Framatome and Kinectrics, following regulatory and other approvals, are uniquely positioned to fulfil the necessary requirements to establish isotope production units at the Bruce Power Reactors that meet the high standards required for ITM’s proprietary n.c.a Lutetium-177 production process.

“We are very pleased about the successful completion of our feasibility study and being able to meet ITM´s high standards”, said James Scongack, Executive Vice-President Corporate Affairs and Operational Services. “Through our partnership with Kinectrics and Framatome, we look forward to becoming part of a global network providing the highly pure medical radioisotope n.c.a. Lutetium-177 to a growing number of cancer patients worldwide.”

The feasibility study examined factors such as technical, medical and nuclear regulatory requirements, radiation protection and waste management. The study also verified the specific requirements of compatibility with ITM’s target and processing technology.

“After the excellent results of our joint feasibility study with Bruce Power and its partners Framatome and Kinectrics we are looking forward to the start of the construction of the irradiation facilities at Bruce Power shortly” added Steffen Schuster, CEO of ITM. “We are delighted that with Bruce Power we have found a strong and reliable partner, with whom we can ensure security of supply of no-carrier-added Lutetium-177 for cancer patients worldwide used in Targeted Radionuclide Therapy.”

N.c.a. Lutetium-177 is a key radiopharmaceutical component which is successfully applied in Targeted Radionuclide Therapies (TRT) for the treatment of a growing variety of cancers such as neuroendocrine tumors, prostate cancer or bone metastases. N.c.a. Lutetium-177 provides the highest specific activity and an unrivalled level of radionuclidic purity, as it contains no metastable Lutetium-177m impurities.* This is especially important in an increasing number of countries and regions that are subject to strict radiation protection regulations with a release limit of Lutetium-177m into the environment. In such places, the radioisotope form containing Lutetium-177m can, in most cases, not be used. On August 21, new regulations by the Environmental Protection Agency (EPA) for the disposal of hazardous drugs by healthcare institutions, providers and pharmacies came into force in the United States. According to these new rules, flushing hazardous waste pharmaceuticals into the sewage system is prohibited by law.

The installation of the irradiation equipment at Bruce Power, by Framatome and Kinectrics, will be consistent with ITM’s specifications and is currently planned for late-2021. Bruce Power will provide the infrastructure and be responsible for the irradiation as it currently does with Cobalt. ITM will deliver Ytterbium-176 targets to the irradiation site, while Framatome and Kinectrics will be responsible for handling and preparing the Ytterbium-176 targets according to ITM requirements.

Reference

* Lebedev, N. A. et al. (2000) Radiochemical separation of no-carrier-added 177Lu as produced via the 176Yb (n,y)†177Yb -> 177Lu process. Applied Radiation and Isotopes 53: 421-425.

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