GARCHING / MUNICH, Germany and VANCOUVER, British Columbia, January 30, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9), a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, today announced the signature of a global master clinical supply agreement to support the development of Alpha-9’s Radiopharmaceutical Therapy (RPT) pipeline candidates for the treatment of cancer. Under the terms of the agreement, ITM will supply its medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177Lu) for Alpha-9’s Lutetium-based candidates.
“Entering this strategic collaboration with Alpha-9 underscores our belief in the value of developing established beta-emitters such as Lutetium-177, to advance the radiopharmaceutical industry and maximize patient benefit,” commented Steffen Schuster, CEO of ITM. “Our position as the world’s largest supplier of n.c.a. Lutetium-177 make us an ideal partner for Alpha-9. We look forward to working with a company that shares our vision of improving cancer care and outcomes for patients globally.”
“A stable and reliable supply of high-quality isotopes is key to the successful development of our pipeline, and partnering with ITM is a valuable next step in building out our proprietary offering of differentiated and precise radiopharmaceuticals,” said David Hirsch, M.D., Ph.D., CEO of Alpha-9.
ITM will supply Alpha-9 with its n.c.a. 177Lu for the clinical development of Alpha-9 radiopharmaceutical candidates comprising n.c.a. 177Lu combined with undisclosed targeting molecules. ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. 177Lu and has marketing authorization in the EU (brand name EndolucinBeta®).
About Radiopharmaceutical Therapy (RPT)
Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope such as Lutetium-177 or Actinium-225 to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.
About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances 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 radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com
Alpha-9 Oncology is a clinical stage radiopharmaceutical company developing differentiated and highly targeted radiopharmaceuticals with the potential to meaningfully improve the treatment of people living with cancer. Applying proprietary technologies and deep-foundational expertise, Alpha-9 is on the forefront of engineering bespoke radiopharmaceuticals that are optimized to selectively deliver radiation to tumor sites while minimizing off-target effects. Alpha-9 is advancing a robust pipeline of novel radiopharmaceuticals with a systematic approach to molecule design that offers broad potential for expansion into several validated oncology targets. For more information, please visit www.a9oncology.com.
Notice Regarding Forward-Looking Statements:
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable Canadian securities laws (collectively, “forward-looking statements”). The words “may”, “will”, “potential”, “believes” and “if” are intended to identify forward-looking statements, although not all forward-looking statements contain such terms. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to: those associated with the success of research and development programs, the ability to raise additional funding, and the need to obtain regulatory approval. Forward-looking statements are made as of the date hereof, and ITM and Alpha-9 disclaim any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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