New isotope production system at Bruce Power

The isotope production system, the first of its kind, continues to progress towards industrial-scale commercial production of medical isotopes for the treatment of cancer

ONTARIO, CANADA, and MUNICH, GERMANY – June 21, 2022 – An international collaboration between Bruce Power, Isogen (Kinectrics and Framatome), and ITM Isotope Technologies Munich SE (ITM)today announced a milestone marking the first instance of lutetium-177, a short-lived medical isotope, has been produced in a commercial nuclear reactor.

This milestone was achieved using a new Isotope Production System (IPS) that was installed in Bruce Power Unit 7 during a recent planned maintenance outage. IPS has successfully irradiated targets to produce lutetium-177, a medical isotope used in precision oncology for the targeted treatment of a growing number of cancers. Lutetium-177 based treatments are designed to precisely target malignant cells while sparing surrounding healthy tissue.

“Bruce Power and our partners at Isogen, ITM and Saugeen Ojibway Nation are thrilled to have reached this exciting milestone, bringing our partnership project to its final stages as we complete commissioning and approach commercial operations,” said James Scongack, Bruce Power Chief Development Officer and Executive Vice President, Operational Services. “Today’s announcement is the culmination of years of hard work by hundreds of dedicated people and we are proud to demonstrate the power of Bruce Power’s CANDU reactors to deliver reliable, large-scale production of essential medical isotopes for use in the fight against cancer.

As part of commissioning activities, ytterbium-176 was successfully irradiated using the IPS, designed and installed by Isogen, to produce lutetium-177. These isotopes were then sent to ITM in Germany for processing, using its proprietary manufacturing methodology and industrial-scale production capabilities, producing high-quality, pharmaceutical-grade lutetium-177 with no added carriers (nec lutetium- 177), which ITM provides for health. healthcare facilities around the world. Nca lutetium-177 has been used successfully in various clinical and commercial radiopharmaceutical cancer treatments. ITM holds a US Drug Master File (DMF) with the Food and Drug Administration (FDA) for nec lutetium-177 and has marketing authorization in the EU (brand name EndolucinBeta^®).

“After the IPS goes live, physicians and their patients around the world will have access to a new, reliable supply of lutetium-177 for their cancer treatments,” said David Harris, CEO of Kinectrics. “In addition, through our partner ITM, pharmaceutical developers can count on a large-scale supply of Lutetium-177 for their clinical trials and commercial products. This milestone demonstrates Kinectrics, Bruce Power, ITM and Framatome’s commitment to innovation and their ability to come together and deliver a large-scale EPC project with both local and global economic impact. on health care.

“Carrying out the design, development, installation and implementation stages of a complex project such as the IPS requires a high level of expertise and commitment”, said François Gauché, Director of Framatome Healthcare at Framatome. “We commend our Isogen project team working with Bruce Power, who tenaciously walked through each step, and we look forward to the first delivery of Lutetium-177 to ITM. We salute Bruce Power’s commitment to innovation that supports the continued production of electricity and medical isotopes, and harnessing the therapeutic power of nuclear energy. We are proud to play an essential role in the development of this production system which supports the value chain of radiopharmaceutical isotopes used for diagnostic imaging and for therapeutic purposes.

ITM will receive exclusive access to the irradiation service provided by IPS for the production of Lutetium-177, further expanding its capabilities to produce this high quality isotope at scale for hospitals around the world, global partners and the ITM’s own clinical pipeline of radiopharmaceuticals for hard-to-treat cancers.

“This state-of-the-art irradiation site, the first of its kind, is the result of the combined expertise of Bruce Power, Isogen and ITM, the strong commitment of our partners and our shared belief in the importance of lutetium-177 in new cancer. therapy,” said Steffen Schuster, CEO of IMT. “Exclusive access to the new isotope production system will allow ITM to further develop our global pharmaceutical production of nec lutetium-177, which is essential to meet the growing demand for high-quality medical isotopes for use in therapy. targeted by radionuclides for cancer patients worldwide. ”

Bruce Power will market the new isotope supply through a historic collaborative partnership with Saugeen Ojibway Nation (SON). The partnership project with SON, named Gamzook’aamin Aakoziwinincludes an equity stake in SON and a revenue sharing program that provides a direct benefit to the community.

“Today’s announcement is a great victory for our Gamzook’aamin Aakoziwin project, which is well on its way to meeting the growing demand from physicians and cancer patients around the world for medical isotopes,” said Chief Veronica Smith, Chippewas of Nawash Unceded First Nation. “We all know someone who has been touched by cancer, and the Saugeen Ojibway Nation is proud of the role we have played and will continue to play in this project to help those in need of treatment using these innovative drugs.

“As researchers search for new ways to fight cancer, lutetium-177 has emerged as a way to treat patients non-invasively,” added Chief Lester Anoquot, Chippewas of Saugeen First Nation. “This project comes online as the demand for treatments increases daily, and it will provide a much-needed source of these isotopes for patients close to home, in our communities and around the world.”

Now that this milestone has been achieved, commissioning activities will be completed this summer and followed by commercial operations, pending final regulatory review and approval from the Canadian Nuclear Safety Commission (CNSC).

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

To learn more, watch a video about today’s announcement here.

About Bruce Power
Bruce Power is an electricity company based in Bruce County, Ontario. We are powered by our people. 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 about www.brucepower.com and follow us on Facebook, Twitter, LinkedIn, instagram and Youtube.

About Isogen
isogenic 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 illnesses around the world. Isogen’s partnerships with Bruce Power and ITM enables us to produce the world’s largest and most reliable supply of short-lived, life-saving therapeutic medical isotopes. Learn more about 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. 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.

For more information contact:

• Press Release: ITM: New Bruce Power Isotope Production System Successfully Produces First Medical Isotope