Isotope Production System begins commercial production of

Tiverton, Ontario, Oct. 24, 2022 (GLOBE NEWSWIRE) — An international collaboration between Bruce Power, Isogen (a Kinectrics and Framatome company) and ITM Isotope Technologies Munich SE (ITM), today announced the start of commercial production of lutetium-177.

The announcement was celebrated at ITM’s headquarters in Munich, Germany, with representatives of partner organizations during a trade mission with Vic Fedeli, Minister of Economic Development, Job Creation and Trade of the ‘Ontario.

This milestone was achieved following final commissioning and regulatory approval from the Canadian Nuclear Safety Commission and is the culmination of a multi-year project to install a new Isotope Production System (IPS ) in Unit 7 of Bruce Power. It is the first-of-its-kind realization of a commercial power reactor with additional capacity to commercially produce short-lived medical isotopes.

The IPS will provide reliable industrial-scale production of lutetium-177, a medical isotope used for targeted cancer therapies. Lutetium-177 is used to deploy precision nuclear medicine that precisely targets malignant cells while sparing surrounding healthy tissue.

“Ontario’s nuclear industry supports thousands of highly skilled jobs and is at the forefront of innovation,” said Premier Doug Ford. “Today’s announcement is a major step forward in making Ontario a world leader in the production of isotopes in the fight against cancer. This unique international project using made-in-Ontario infrastructure will help doctors and patients across the country and around the world have better access to the life-saving isotopes they need.

“It is with great pride that Bruce Power, along with our partners at Isogen, ITM and Saugeen Ojibway Nation, celebrate the successful start of commercial operation of the world’s first large-scale isotope production system for production of lutetium-177,” said Mike Rencheck, President and CEO of Bruce Power. “This announcement is the result of years of dedication and comes thanks to the hard work and innovative spirit of thousands of employees through this unique international partnership.”

The Ontario-made IPS, designed and installed by Isogen at Bruce Power, irradiates ytterbium-176 to produce lutetium-177, which is then transported to ITM’s manufacturing facility in Germany for processing of lutetium from pharmaceutical grade without added carrier -177 (nec lutetium-177). ITM is a supplier of nec lutetium-177 to healthcare facilities around the world, and the isotope has been used successfully in various clinical and commercial radiopharmaceutical treatments for cancer.

“Today we celebrate the efforts of Bruce Power, ITM, our Kinectrics staff and our partner in Isogen, Framatome, whose collective efforts have enabled the start of the commercial supply of Lutetium-177,” said David Harris, CEO of Kinectrics. “Today marks a paradigm shift in the supply of medical isotopes where the international medical community can now rely on scalable, reliable isotopes produced by Canadian power reactors for their cancer treatments.

The IPS will leverage Bruce Power’s continuous 24/7 operations to provide a constant and scalable supply of life-saving isotopes that will be used by physicians to treat cancer patients around the world.

“We commemorate this historic achievement which promises potentially life-saving medical treatments for cancer patients,” said Bernard Fontana, CEO of Framatome. “Our shared vision with our partner Isogen Kinectrics and Bruce Power, together with ITM, has led to this important milestone. We are proud of our teams who persevered to design, develop, install and implement this ambitious and complex project. As part of our Framatome Healthcare brand, we are honored to play a vital role in ensuring a reliable supply of isotopes, including Lutetium-177, to medical communities around the world. »

Commercial exploitation of IPS will enable large-scale production of lutetium-177 at a time when global demand for these short-lived isotopes is on the rise. ITM holds a US Drug Master File (DMF) with the FDA for nec lutetium-177 and has marketing authorization in the EU (brand name EndolucinBeta^®). IMT has exclusive access to the irradiation service provided by IPS for the production of lutetium-177 and will utilize the increased supply of high-quality isotopes from IPS to meet the growing demand from physicians and patients.

“As the world’s largest supplier of high-quality nec lutetium-177 for therapeutic cancer treatments, we are always looking to expand our production network to secure supply to provide access to hospitals and patients around the world. worldwide, and this collaboration demonstrates that commitment,” added Steffen Schuster, CEO of ITM. “We are grateful to our partners for this smooth scale-up to commercial production which will ensure the safety of production of our own Phase 3 assets as well as our commitment to currently approved targeted radionuclide therapies leveraging the lutetium-177.”

Vic Fedeli, Ontario’s Minister of Economic Development, Job Creation and Trade, expressed his support for international collaboration and his advancement of Ontario as a global hub for manufacturing and isotope innovation.

“International partnerships like this one between Bruce Power, Isogen and ITM pave the way for future innovation in key sectors in Ontario,” said Minister Fedeli. “Congratulations to everyone involved in this milestone achievement in the production of life-saving medical isotopes! Together, we are building Ontario and continuing to ensure the province is a leader in the life sciences sector and the global isotope supply chain.

Bruce Power will work with Saugeen Ojibway Nation to commercialize the new isotope supply through an equity partnership named Gamzook’aamin Aakoziwin.

“The Gamzook’aamin Aakoziwin Project has taken years to develop and today marks another exciting step on the road to the global fight against cancer,” said Chief Conrad Ritchie, Chippewas of Saugeen First Nation. “These medical isotopes will be used to help patients receive cancer-fighting treatments, not just at home in our communities, but around the world.”

“We are proud to be part of this innovative project, which will have a positive impact on the healthcare community worldwide,” said Chief Veronica Smith, Chippewas of Nawash Unceded First Nation. “By working together in this partnership, we are playing a leadership role in the fight against cancer and continuing to increase access to isotopes that are essential for innovative cancer treatment and diagnosis.

Learn more about how isotopes help keep hospitals safe and diagnose and treat cancer at www.brucepower.com/isotopes.

About Bruce Power
Bruce Power is an electricity company based in Bruce County, Ontario. We are powered by our employees. Our 4,200 employees are the foundation of our accomplishments and are proud of the role they play in safely providing clean, reliable, low-cost nuclear power to families and businesses across the province, as well as medical isotopes vital all over the world. Bruce Power has worked hard to establish strong roots in Ontario and is committed to protecting the environment and supporting the communities in which we live. Formed in 2001, Bruce Power is a Canadian-owned partnership of TC Energy, OMERS, the Power Workers’ Union and the Society of United Professionals. Learn more at www.brucepower.com and follow us on Facebook, Twitter, LinkedIn, Instagram and YouTube.

About Isogen

Isogen is a joint venture between Framatome and Kinectrics, whose mission is to enable the use of CANDU reactors to produce the medical isotopes needed to treat and diagnose patients with serious diseases worldwide. Isogen’s enabling partnerships with Bruce Power and ITM enable us to produce the world’s largest and most reliable supply of life-saving, short-lived therapeutic medical isotopes. Learn more at www.isogen.ca and follow us on LinkedIn.

About ITM Isotope Technologies Munich SE

ITM, a leading radiopharmaceutical biotechnology company, is dedicated to providing a new generation of radiomolecular precision therapies and diagnostics for difficult-to-treat tumors. Our goal is to meet the needs of cancer patients, clinicians and our partners through excellence in development, manufacturing and global supply. With improved patient benefits as the guiding principle of everything we do, ITM is advancing a broad precision oncology pipeline, including two Phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharmaceutical expertise, our central position in the industry and our established global network, ITM strives to provide patients with more effective targeted therapy to improve clinical outcomes and quality of life. More information on: www.itm-radiopharma.com

ITM Medical Isotopes GmbH, a wholly owned subsidiary of ITM Isotope Technologies Munich SE, had signed a lutetium-177 supply agreement with Isogen in 2020.

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