On 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, reported 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 (Press release, ITM Isotopen Technologien Munchen, JAN 30, 2024, View Source [SID1234639722]). 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.
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"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.