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ITM and ILL Extend Collaboration on the Manufacturing and Supply of Medical Lutetium-177 Radioisotope
ITM and ILL Extend Collaboration on the Manufacturing and Supply of Medical Lutetium-177 Radioisotope

Associated Press

time16-06-2025

  • Business
  • Associated Press

ITM and ILL Extend Collaboration on the Manufacturing and Supply of Medical Lutetium-177 Radioisotope

Garching / Munich, Germany, and Grenoble, France, June 16, 2025 – ITM Isotope Technologies Munich SE (ITM) and the Institut Laue-Langevin (ILL), today announced an extension of their collaboration for medical radioisotope production, originally established in 2009. Under the terms of the renewed agreement, ITM will receive priority access to half of the available neutron irradiation capacity at ILL's High-Flux Reactor, its neutron irradiation facility, for the production of non-carrier-added Lutetium-177 (n.c.a. Lu-177), a critical medical radioisotope used for radiopharmaceutical therapies for cancer treatment and diagnosis. As the globally leading manufacturer of n.c.a. Lu-177, ITM is committed to maintaining and expanding its robust manufacturing and production capabilities to meet the growing demand for this vital medical radioisotope. 'ITM and ILL's longstanding partnership began in 2009, when the radiopharmaceutical industry was still in its infancy,' commented Dr. Andrew Cavey, CEO of ITM. 'Our priority access to ILL's renowned high-flux irradiation services is incredibly important as the demand for n.c.a. Lutetium-177 grows and as our radiopharmaceutical pipeline evolves.' The high neutron flux of ILL's reactor provides ITM with a high yield of Lu-177, and allows for a particularly sustainable production of the medical radioisotope by minimizing use of the scarce precursor raw material, Ytterbium-176 (Yb-176). Providing radioisotopes to ITM plays a significant role in enabling geographic and industrial return from ILL to its funding countries, fostering innovation and supporting advancements in radiopharmaceutical research and production. Radiopharmaceutical Therapy (RPT) is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to healthy 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. About the ILL, Institut Laue-Langevin The ILL is the world-leading facility in neutron science and technology. Delivering the most intense neutron beams in the world to its unparalleled suite of 43 state-of-the-art neutron scattering instruments, the ILL offers a unique tool for probing the heart of matter. Every year, around 1500 international researchers visit the ILL to carry out over 1000 cutting-edge experiments in a variety of disciplines, including physics, chemistry, biology, and material science and engineering. Besides its impact in scientific research and education excellence, the ILL helps drive innovation in the fields of health, energy, the environment and quantum materials. The ILL is engaged in the production of radioisotopes for medical applications since more than 15 years now. A major European project, the ILL was founded in Grenoble in 1967 by France and Germany, joined a few years later by the UK. Today, 13 countries fund the facility for their research communities. ITM Contact Corporate Communications Kathleen Noonan / Julia Westermeir Phone: +49 89 329 8986 1500 Email: [email protected] Investor Relations Ben Orzelek Phone: +49 89 329 8986 1009 Email: [email protected] ILL Contact Radionuclide Production Ulli Köster Phone: (+33) (0)4 76 20 71 54 Email: [email protected] Communications Catarina Espirito Santo Phone: (+33) (0)4 76 20 71 07 Email: [email protected] Attachment

ITM and ILL Extend Collaboration on the Manufacturing and Supply of Medical Lutetium-177 Radioisotope
ITM and ILL Extend Collaboration on the Manufacturing and Supply of Medical Lutetium-177 Radioisotope

Yahoo

time16-06-2025

  • Business
  • Yahoo

ITM and ILL Extend Collaboration on the Manufacturing and Supply of Medical Lutetium-177 Radioisotope

Garching / Munich, Germany, and Grenoble, France, June 16, 2025 – ITM Isotope Technologies Munich SE (ITM) and the Institut Laue-Langevin (ILL), today announced an extension of their collaboration for medical radioisotope production, originally established in 2009. Under the terms of the renewed agreement, ITM will receive priority access to half of the available neutron irradiation capacity at ILL's High-Flux Reactor, its neutron irradiation facility, for the production of non-carrier-added Lutetium-177 (n.c.a. Lu-177), a critical medical radioisotope used for radiopharmaceutical therapies for cancer treatment and diagnosis. As the globally leading manufacturer of n.c.a. Lu-177, ITM is committed to maintaining and expanding its robust manufacturing and production capabilities to meet the growing demand for this vital medical radioisotope. 'ITM and ILL's longstanding partnership began in 2009, when the radiopharmaceutical industry was still in its infancy,' commented Dr. Andrew Cavey, CEO of ITM. 'Our priority access to ILL's renowned high-flux irradiation services is incredibly important as the demand for n.c.a. Lutetium-177 grows and as our radiopharmaceutical pipeline evolves.' The high neutron flux of ILL's reactor provides ITM with a high yield of Lu-177, and allows for a particularly sustainable production of the medical radioisotope by minimizing use of the scarce precursor raw material, Ytterbium-176 (Yb-176). Providing radioisotopes to ITM plays a significant role in enabling geographic and industrial return from ILL to its funding countries, fostering innovation and supporting advancements in radiopharmaceutical research and production. Dr. Ken Andersen, Director of the Institut Laue-Langevin added, 'ILL operates the world-leading neutron source for research by neutron scattering and in nuclear and particle physics. Moreover, ILL's reactor provides irradiation positions at exceptionally high neutron flux that are exploited both for fundamental research and the production of radionuclides for medical applications. ILL is proud of the longstanding collaboration with ITM, regularly performing irradiations of Ytterbium-176 targets for ITM over the last 15 years, and looks forward to an even closer partnership in the coming years.'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 healthy 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 SEITM, 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. the ILL, Institut Laue-LangevinThe ILL is the world-leading facility in neutron science and technology. Delivering the most intense neutron beams in the world to its unparalleled suite of 43 state-of-the-art neutron scattering instruments, the ILL offers a unique tool for probing the heart of matter. Every year, around 1500 international researchers visit the ILL to carry out over 1000 cutting-edge experiments in a variety of disciplines, including physics, chemistry, biology, and material science and engineering. Besides its impact in scientific research and education excellence, the ILL helps drive innovation in the fields of health, energy, the environment and quantum materials. The ILL is engaged in the production of radioisotopes for medical applications since more than 15 years now. A major European project, the ILL was founded in Grenoble in 1967 by France and Germany, joined a few years later by the UK. Today, 13 countries fund the facility for their research ContactCorporate CommunicationsKathleen Noonan / Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@ RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@ ContactRadionuclide ProductionUlli Köster Phone: (+33) (0)4 76 20 71 54Email: koester@ Espirito SantoPhone: (+33) (0)4 76 20 71 07Email: communication@ Attachment 20250616_ITM and ILL Extend Collaboration on the Manufacturing and Supply of Medical Lutetium-177 Radioisotope

ITM and Alpha-9 Oncology Enter Into Supply Agreement for Therapeutic Medical Radioisotope Actinium-225
ITM and Alpha-9 Oncology Enter Into Supply Agreement for Therapeutic Medical Radioisotope Actinium-225

Yahoo

time24-04-2025

  • Business
  • Yahoo

ITM and Alpha-9 Oncology Enter Into Supply Agreement for Therapeutic Medical Radioisotope Actinium-225

Garching / Munich, Germany and VANCOUVER, British Columbia, April 24, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9), a clinical-stage biotechnology company advancing a distinctive portfolio of differentiated and highly targeted radiopharmaceuticals, today announced the signing of a supply agreement for Actinium-225 (Ac-225) to support the development of Alpha-9's radiopharmaceutical programs. Under the terms of the agreement, ITM will supply its therapeutic medical radioisotope, Ac-225, produced by ActineerTM Inc. (Actineer), the joint venture between ITM and Canadian Nuclear Laboratories. Actineer is advancing cutting-edge technologies to secure and expand its supply chain and produce industrial-scale quantities of Ac-225 at rapid speed to meet the growing global demand. Further contract details have not been disclosed. 'This agreement strengthens our ongoing collaboration with Alpha-9 and reaffirms our mission to supply Actinium-225 to companies pioneering novel radiopharmaceuticals for high unmet need cancer indications,' said Dr. Andrew Cavey, CEO of ITM. 'We deeply value Alpha-9's continued trust in our capabilities to produce industrial-scale radioisotopes, supporting the development of breakthrough treatments that can potentially improve the lives of patients with cancer worldwide.' Ac-225 is a rare medical radioisotope used in radiopharmaceuticals to treat various cancer indications. It emits high-energy alpha particles with a short penetration range in tissue, enabling precise targeting of tumor cells. Studies with Ac-225 have shown it to cause double-stranded DNA breaks in cancer cells, leading to their destruction1. Its unique qualities along with its natural scarcity and manufacturing complexities make Ac-225 a highly sought after resource. With a comparatively short half-life of approximately ten days2, Ac-225 requires a highly sophisticated manufacturing and distribution network worldwide. 'With its global strength in providing high-quality radioisotopes including. Lutetium-177 and their growing capabilities for the production of Actinium-225, ITM is a valued partner as we progress our pipeline of clinical and discovery programs to meet the needs of cancer patients,' said Alison Fleming Ph.D., COO of Alpha-9 Oncology. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical 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 multiple phase 3 studies, combining the company's high-quality radioisotopes with a range of targeting molecules. By leveraging our 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. About Actineer, Inc. is a joint venture company between Canadian Nuclear Laboratories (CNL) and ITM Isotope Technologies Munich SE (ITM) dedicated to advancing Ac-225 technologies, quickly securing supply, and producing industrial-scale quantities of this valuable, rare medical radioisotope for the treatment of cancer. Founded in October 2023, Actineer™ Inc. together with its strong supply chain collaborators seeks to progress Ac-225 development, production, and processing technologies. It has established short-term production capabilities that is expected to lead to significantly boosting international supplies, while working long-term towards the construction of a new Actinium Production Facility (APF) in Canada. The joint venture's mission is to fulfil the unmet global manufacturing and production needs of this coveted radioisotope with significant potential in the fight against cancer. About Alpha-9 Oncology Oncology Inc. 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 ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@ Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@ Alpha-9 ContactCorporate CommunicationsStephen MitchenerPhone: +1 617 865 1004Email: smitchener@ 1Bidkar AP, Zerefa L, Yadav S, VanBrocklin HF, Flavell RR. Actinium-225 targeted alpha particle therapy for prostate cancer. Theranostics. 2024 May 11;14(7):2969-2992. doi: 10.7150/thno.96403. PMID: 38773983; PMCID: PMC11103494. 2Hooijman, E.L., Radchenko, V., Ling, S.W. et al. Implementing Ac-225 labelled radiopharmaceuticals: practical considerations and (pre-)clinical perspectives. EJNMMI radiopharm. chem. 9, 9 (2024). Attachment 20252404_ITM and Alpha-9 Oncology Enter Into Supply Agreement for Therapeutic Medical Radioisotope Actinium-225Sign in to access your portfolio

ITM to Present at Raymond James Private Biotech Symposium
ITM to Present at Raymond James Private Biotech Symposium

Yahoo

time18-02-2025

  • Business
  • Yahoo

ITM to Present at Raymond James Private Biotech Symposium

Garching / Munich, February 18, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced its participation in the Raymond James Private Biotech Symposium. Dr. Andrew Cavey, CEO of ITM, will deliver a virtual corporate presentation highlighting the Company's deep and robust radiopharmaceutical pipeline, opportunities, and upcoming milestones on Thursday, February 20, 2025 at 9:20 AM further information, please contact: Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@ ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@ ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical 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 multiple Phase 3 studies, combining the company's high-quality radioisotopes with a range of targeting molecules. By leveraging our 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. Attachment 20250218_ITM to Present in Raymond James Private Biotech SymposiumSign in to access your portfolio

ITM's radiotherapeutic beats out standard-of-care in Phase III trial
ITM's radiotherapeutic beats out standard-of-care in Phase III trial

Yahoo

time28-01-2025

  • Business
  • Yahoo

ITM's radiotherapeutic beats out standard-of-care in Phase III trial

ITM Radiopharma's Phase III trial of its targeted radiotherapeutic for patients with Grade 1 or 2 gastroenteropancreatic neuroendocrine tumours (GEP-NETs) has hit the primary endpoint of prolonging progression-free survival (PFS). The Munich-based company has confirmed that its prospective, randomised, open-label trial of ITM-11 met its primary endpoint demonstrating a statistically significant benefit in PFS when compared to standard-of-care (SOC) Novartis' Afinitor (everolimus). The company plans to submit data from the Phase III trial as part of a future regulatory submission for approval at some stage this year. The Phase III COMPETE trial (NCT03049189) also evaluated secondary endpoints, including objective response rate (ORR), overall survival (OS), and quality of life (QoL) assessments, however, these are yet to be fully analysed. Investigator for the trial, Jaume Capdevila, said: 'With COMPETE, this marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved PFS compared to a targeted molecular therapy, Afinitor, in patients with Grade 1 and 2 gastroenteropancreatic neuroendocrine tumours in a Phase III clinical trial. 'The patients included represent a real-life scenario, and the COMPETE study evaluates the important question of which therapy might be used first to provide greater benefit to patients.' The trial enrolled 309 patients with Grade 1 or 2 inoperable, progressive, somatostatin receptor-positive neuroendocrine tumours. Patients were randomised to receive ITM-11 with a nephroprotective amino acid solution every three months, or Afinitor 10 mg daily for up to 30 months or until the disease progressed. Andrew Cavey, CEO of ITM, added: 'People with GEP-NETs, whose journey from diagnosis to proper treatment can take years, remain in significant need of more robust, data-driven treatment options to maximize outcomes. The successful COMPETE data support ITM-11's potential and we believe marks an important milestone for patients and for ITM.' The news follows after the company aired concerns that whilst the radiotherapeutics space is set to grow, red tape and industry complexities are holding progress in the space back. Meanwhile, Austrian competitor Telix Pharmaceuticals has announced a 55% year-on-year revenue increase in 2024. "ITM's radiotherapeutic beats out standard-of-care in Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio

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