Articles from ITM Isotope Technologies Munich SE

Garching / Munich, Germany, April 01, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Celine Wilke, MD, as Chief Medical Officer. Dr. Wilke holds nearly 20 years of industry experience, most recently in radiopharmaceutical drug development. Prior to ITM, as Senior Global Program Clinical Head for prostate cancer at Novartis, Dr. Wilke oversaw clinical trials for radiopharmaceutical therapies and imaging compounds, resulting in the global approvals of Pluvicto® and Locametz®. At ITM, she will lead the clinical development and medical teams in bringing ITM-11 toward potential market approval and further accelerating the development of the company’s radiopharmaceutical pipeline.

Garching / Munich, Germany, March 13, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced updates to its commercial leadership. Dr. Sebastian Marx, a member of ITM’s Executive Board and Chief Business Officer will step down on July 20, 2025 and will depart the company. He has been a member of the company’s Executive Board since 2022 and an employee since 2008, and has nearly two decades of leadership in building ITM’s business.

Krakow, Poland March 6, 2025 - ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today presented positive topline data from its Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial results demonstrated that n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide), a proprietary, synthetic, targeted radiotherapeutic agent, met the primary endpoint and significantly prolonged progression-free survival in patients when compared to everolimus, a standard of care cancer treatment. The data were presented by study investigator Jaume Capdevila, MD, PhD, at the 22nd Annual European Neuroendocrine Tumor Society (ENETS) 2025 Conference, held in Krakow, Poland from March 5-7, 2025.

Garching / Munich, February 25 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it will provide topline data results from its Phase 3 COMPETE trial in an oral presentation at the 22nd Annual European Neuroendocrine Tumor Society (ENETS) Conference 2025, held from March 5 – March 7, 2025 in Kraków, Poland.

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 ET.For further information, please contact:

Garching / Munich, February 7, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced its participation in Oppenheimer’s 35th Annual Healthcare Life Sciences Conference. 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 Tuesday, February 11, 2025 at 8:40 AM ET.For further information, please contact:

Garching / Munich, January 28, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced positive topline results from its Phase 3 COMPETE trial in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The data showed that ITM-11 (n.c.a. 177Lu-edotreotide), a proprietary, synthetic, targeted radiotherapeutic agent, met the primary endpoint of prolonging progression-free survival (PFS) when compared to everolimus, a targeted molecular therapy. ITM-11 was well-tolerated with favorable safety results observed. COMPETE is a prospective, randomized, controlled, open-label Phase 3 trial evaluating the efficacy and safety of ITM-11 compared to everolimus, a standard of care treatment. ITM-11 is comprised of non-carrier-added (n.c.a.) lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a somatostatin receptor (SSTR) agonist. The trial enrolled 309 patients with Grade 1 or Grade 2 inoperable, progressive, somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin (Ki-67 ≤20%). Patients were randomized 2:1 to receive 7.5 GBq of ITM-11 with a nephroprotective amino acid solution every three months for a maximum of four cycles, or everolimus 10 mg daily for up to 30 months, or until disease progression. The COMPETE trial was conducted at multiple sites throughout the world.“With COMPETE, this marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved progression-free survival compared to a targeted molecular therapy, everolimus, in patients with Grade 1 and Grade 2 gastroenteropancreatic neuroendocrine tumors in a Phase 3 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,” said Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, Barcelona. “As a clinician, I am highly encouraged by these data and look forward to seeing further results.”“We want to thank the patients, families and caregivers, and investigators for their commitment to and trust in this trial. 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 mark an important milestone for patients and for ITM,” said Dr. Andrew Cavey, CEO of ITM. “Our organization now has demonstrated both early and late-stage clinical development capabilities that complement our leadership in global isotope manufacturing.” Secondary endpoints in the COMPETE trial include objective response rate, overall survival, and quality of life assessments. Additionally, dosimetry was used to assess the absorbed ITM-11 dose in tumors compared to that in healthy tissue to enhance monitoring of the patient's safety and efficacy. These dosimetry data and secondary endpoints, along with subgroup analyses, are currently being evaluated.The company plans to submit the results for presentation at a future medical meeting and anticipates discussing a potential New Drug Application (NDA) submission with the FDA in 2025.In addition to the COMPETE trial, ITM-11 is being evaluated in a Phase 3 trial (COMPOSE) in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. The COMPOSE trial is a prospective randomized, controlled, open-label trial evaluating the efficacy, safety and patient-reported outcomes of ITM-11 as first or second line treatment compared to physician’s choice standard of care chemotherapy. Additional clinical programs with ITM-11 include a Phase 1 pediatric trial in SSTR-positive tumors (KinLET) and a Phase 3 investigator-sponsored trial in lung and thymus neuroendocrine tumors (LEVEL).About GEP-NETSNeuroendocrine tumors (NETs) are a rare form of cancer, with an estimated 8 new cases per 100,000 individuals diagnosed each year in the U.S. and 9 cases per 100,000 in Europe. The incidence of NETs has steadily increased over recent decades, resulting, in part, from improved diagnosis. Gastroenteropancreatic neuroendocrine tumors (GEP-NETS) originate in the neuroendocrine system, and are made up of nerve cells and hormone-producing cells. They can occur anywhere in the GI tract and pancreas, including the stomach, small intestine, colon, rectum, and appendix. There is still a high unmet medical need for treatment options, as many patients are asymptomatic and diagnosed at a late stage with metastatic disease. About ITM-11 (n.c.a. 177Lu-edotreotide) ITM-11 is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. ITM-11, delivered intravenously, is comprised of non-carrier-added lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. ITM-11 was granted orphan drug designation in the EU and the US, and fast track designation in the US for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study1 with 177Lu-edotreotide.     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. www.itm-radiopharma.comITM Contact Corporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.comInvestor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.comReferences:

Garching / Munich / Berlin, Germany, January 13, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced the execution of a supply agreement for non-carrier-added (n.c.a.) Actinium-225 (Ac-225) to support the development of Ariceum’s novel targeted radiopharmaceutical therapies (RPT) pipeline, including its lead radiopharmaceutical drug, satoreotide for the treatment of aggressive, hard-to-treat cancers.Under the terms of the agreement, ITM will supply the therapeutic medical radioisotope, Ac-225, produced by Actineer™ Inc, ITM’s joint venture company with Canadian Nuclear Laboratories, for use in Ariceum’s Actinium-based pipeline candidates. Actineer is advancing cutting-edge technologies to secure and expand its supply chain and produce industrial-scale quantities of Ac-225 at rapid speed by irradiating Radium-226 (Ra-226) in cyclotrons to meet the growing demand for this promising medical radioisotope on a global scale. Additional details of the supply agreement have not been disclosed. “We value our partnership with Ariceum which marks a significant step forward in advancing our mission to provide this critical medical radioisotope to the radiopharmaceutical industry,” said Dr. Andrew Cavey, Chief Executive Officer at ITM. “With our extensive experience in the production and supply of Lutetium-177, we are well-equipped to apply that expertise to Actinium-225 via our joint venture, Actineer. Our agreement with Ariceum strengthens our commitment to advancing innovative solutions for cancer treatment and to meeting the needs of our partners and people living with cancer worldwide.”Ac-225 is a rare medical radioisotope used in RPTs for the treatment of various cancer indications. It emits high-energy alpha particles with a short penetration range in tissue, enabling precise targeting of tumor cells. This unique quality has made Ac-225 an increasingly sought-after resource in the field, with growing demand. Its natural scarcity and manufacturing complexities have contributed to critical shortages that have threatened the development of novel radiopharmaceuticals that have the potential to treat challenging cancer indications. “Securing a reliable and plentiful supply of n.c.a. Ac-225 is critical to our efforts in developing innovative cancer treatments with our pipeline of novel targeted radiopharmaceuticals,” commented Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics. “Our agreement with ITM and its joint venture company Actineer supports our access to valuable resources needed to explore the full potential of Ac-225 in unlocking and advancing new Targeted Alpha Therapy approaches for patients living with difficult-to-treat cancers.” 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 multiple phase III 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. www.itm-radiopharma.comAbout Actineer, Inc.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 Ariceum TherapeuticsAriceum Therapeutics is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of ‘Marie Curie’ whose discovery of radium and polonium have been huge contributions to finding treatments for cancer.Ariceum’s lead targeted systemic radiopharmaceutical candidate, 177Lu-satoreotide tetraxetan (“satoreotide”), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in aggressive neuroendocrine tumours (NETs) such as small cell lung cancer (SCLC) or Merkel Cell Carcinoma (MCC), all of which have limited treatment options and poor prognosis. Satoreotide is being developed as a ‘theranostic pair’ for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), currently in Phase 1 clinical development under the trial name CITADEL-123. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023.Ariceum Therapeutics, launched in 2021, acquired all rights to satoreotide from Ipsen, which has remained a shareholder of the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, the United Kingdom, and the United States.Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital. For further information, please visit www.ariceum-therapeutics.com.CONTACTS: ITM ContactCorporate CommunicationsKathleen Noonan / Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.comInvestor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.comAriceum TherapeuticsManfred Rüdiger, CEOEmail: info@ariceum-therapeutics.comOptimum Strategic Communications 

Garching / Munich, Germany, December 13, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that its Chief Executive Officer, Dr. Andrew Cavey and Chief Financial Officer, Dr. Klaus Maleck will participate in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. Dr. Andrew Cavey will present a corporate overview on Monday, January 13, 2025, at 11:30 am PST in the Mission Bay Room (32nd Floor) at The Westin St. Francis.

Garching / Munich, November 11, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced its participation in two upcoming industry investor conferences. ITM's Chief Executive Officer, Dr. Andrew Cavey, will participate in a virtual fireside chat at the William Blair Investor Conference. Dr. Cavey, together with ITM’s CFO, Dr. Klaus Maleck, will also attend the Jefferies London Healthcare Conference 2024. Additional information on the events can be found below.

Neufahrn / Garching / Munich, Germany, October 24, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, the Technical University of Munich (TUM) and the TUM University Hospital (Klinikum rechts der Isar der Technischen Universität or MRI), today announced a new framework agreement for the research and development of innovative radiopharmaceuticals and radionuclides for the treatment of cancer. This collaboration builds on a long-standing partnership and previously established cooperation agreement between ITM and TUM. The new agreement aims to further accelerate nuclear medicine initiatives by integrating ITM’s expertise in medical radioisotope production and radiopharmaceutical development with TUM’s cutting-edge research capabilities in nuclear physics (FRM II research reactor) and medical applications, alongside MRI’s renowned clinical expertise in diagnostics and patient care. The framework agreement also outlines how ITM and TUM will share and transfer the rights to any results or inventions that come from their future collaboration. Additional details of the framework agreement have not been disclosed.

 

 

Garching / Munich, Germany, May 7, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Danielle Meyrick, PhD, MD, as Chief Medical Officer. Dr. Meyrick brings more than 20 years of medical research, radiotheranostic drug development and management experience to ITM. She has held senior leadership roles across international biotech and radiopharmaceutical organizations including GenesisCare, AdvanCell Isotopes and Telix Pharmaceuticals. Dr. Meyrick will lead ITM’s medical team in expanding and advancing the company’s radiopharmaceutical pipeline while overseeing the last stages of clinical development and commercial readiness for phase III lead candidate, ITM-11. She replaces Dr. Philip E. Harris, ITM’s CMO from 2018, who is retiring from the company.

Garching / Munich, Germany, and Lausanne, Switzerland – September 12th, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, today announced that the companies entered an agreement under which ITM gains the exclusive global license for the clinical and commercial development of the peptide-based, theranostic pair ITM-91/ITM-94D, formerly Debio 0228/0328, targeting the Carbonic Anhydrase IX (CA IX) surface protein. CA IX plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452) is a Lutetium-177-labeled radioligand therapeutic compound and ITM-94D (Debio 0328) ([68Ga]Ga-DPI-4452) is a Gallium-68-labeled imaging agent. The theranostic pair is being investigated in the phase 1/2 GaLuCi™(NCT05706129) clinical trial in patients living with locally advanced ccRCC, PDAC and CRC. Further terms and financial details have not been disclosed.

A Novel Therapeutic Approach to Treatment using ITM-31

Garching / Munich, Germany, June 06, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced an equity investment of €188 million led by Temasek with participation from funds managed by BlackRock1, Qatar Investment Authority (QIA), ATHOS and Carbyne. The new capital will be used to advance and expand ITM’s innovative radiopharmaceutical pipeline, foster its leading development platform and prepare commercial readiness for the potential market launch of the company’s phase III lead candidate, ITM-11 (n.c.a. 177Lu-edotreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Further solidifying its current position in radioisotope supply, ITM will also apply the new funds together with its expertise as the globally leading manufacturer of n.c.a. Lutetium-177 (177Lu) to increase its in-house manufacturing capacities for 177Lu and expand them to new, high-value medical radioisotopes including Actinium-225 (225Ac). The company will provide these sought-after medical radioisotopes to its global supply network and apply them to broaden its own Radiopharmaceutical Therapy (RPT) pipeline designed to address an array of hard-to-treat cancer indications.

Garching / Munich and Princeton, NJ, February 1, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the company has obtained a wholesale license issued by the New Jersey Department of Health (NJDOH) in order to operate as a virtual manufacturer. Obtaining the wholesale license is a pivotal requirement for ITM’s business activities in the United States. This milestone enables the company to distribute its radiopharmaceutical products, thereby facilitating patient access to ITM’s radiopharmaceuticals upon their approval by the U.S. Food and Drug Administration (FDA).

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.

Garching / Munich, January 4, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the receipt of the Radioactive Material Handling License (RAM License) for the company’s NOVA facility, the world’s largest Lutetium-177 production site. Lutetium-177 is an innovative medical radioisotope frequently used in Radiopharmaceutical Therapy (RPT) for the treatment of cancer. Having obtained the RAM License together with other regulatory approvals required, ITM has achieved operational readiness. The RAM License has been granted by the Bavarian Environment Agency (LfU),  the relevant regulatory body, in line with the highest quality standards.

Garching / Munich, Germany, January 16, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Dr. Mark Harfensteller to its Executive Board. Dr. Harfensteller initially joined the ITM Group as Head of Engineering in 2008. He has been appointed as head of production in 2009. Additionally, he became responsible for Research and Development (R&D) in 2011. Since 2016, he has held the position of Chief Operating Officer (COO) and Managing Director of ITM Medical Isotopes GmbH, a subsidiary of ITM SE. Under Dr. Harfensteller’s leadership, the company established an industrial and Good Manufacturing Practice (GMP) compliant production system to meet the increasing demand for medical radioisotopes. He played a significant role in the establishment of ITM’s NOVA facility, the world's largest Lutetium-177 (177Lu) production site and the launch of Actineer™ Inc., ITM’s joint venture with Canadian Nuclear Laboratories (CNL) for the global production of Actinium-225 (225Ac). As a member of ITM’s Executive Board, Dr. Harfensteller joins ITM’s primary leadership level currently consisting of Steffen Schuster, Chief Executive Officer (CEO), Dr. Klaus Maleck, Chief Financial Officer (CFO), and Dr. Sebastian Marx, Chief Business Officer (CBO).

Garching / Munich, Germany, December 21, 2023 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that CEO, Steffen Schuster and CFO, Dr. Klaus Maleck will participate in the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco. Steffen Schuster will present a corporate overview on Tuesday, January 9, 2024, at 9:00 am PST.

 

Garching / Munich, Germany, October 24, 2023 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today reported on its participation at the 3rd International Centers for Precision Oncology (ICPO) Forum for Theranostics in Precision Oncology which took place in Garching near Munich, Germany, from October 12-13, 2023. The company also announced support for the ICPO’s newly established Academy for Theranostics, which was unveiled as part of the event.

Garching / Munich, Germany and Indianapolis, IN, USA, July 31, 2023 –  ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and POINT Biopharma Global Inc. (NASDAQ: PNT) (“POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today announced the expansion of their global supply agreements signed in 2020. The expanded agreement broadens the supply of ITM’s non-carrier-added lutetium-177 (n.c.a. 177Lu) to POINT to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in POINT’s development pipeline. Financial details of the agreement were not disclosed. 

Garching / Munich, June 15, 2023 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it will host a multidisciplinary symposium titled, “Investing in the Future of Theranostics: Aligning Supply to Clinical Need,” at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Therapeutics Conference, held from June 24-27 in Chicago, Illinois, USA. The symposium will take place on June 25, from 6:30 pm to 7:30 pm CST in McCormick Place, Lakeside Center, Room E450b.

Neufahrn / Garching / Munich, June 13, 2023 – ITM Isotope Technologies Munich SE (ITM) announced the opening of its new production facility for therapeutic radionuclides in Neufahrn near Munich, Germany in the presence of Minister of State, Dr. Florian Herrmann and other high-ranking guests. ITM’s new facility is the world’s largest production site of lutetium-177, an innovative medical isotope used in targeted cancer therapies. Due to its medical properties, lutetium-177 has gained importance in precision oncology treatments internationally as a valuable starting material for the production of various radiotherapeutics in recent years.

 

Enhancement of ITM’s development and manufacturing activities strengthens ITM’s position as a pioneer and leader in Targeted Radionuclide Therapy (TRT)

Garching / Munich and Princeton, NJ, April 17, 2023 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical theranostics company, today announced that the company has opened its U.S. headquarters in Princeton, New Jersey and appointed Roger Estafanos as U.S. General Manager. Mr. Estafanos brings a wealth of experience from both the radiopharmaceutical and pharmaceutical industries including being one of the first leaders of the US division of Advanced Accelerator Applications (AAA), a Novartis company. His arrival builds on ITM’s appointment of key hires to its U.S. leadership team in 2022. Establishing the headquarters in Princeton strengthens ITM’s ongoing expansion of its U.S. business, including the sales and marketing of the company’s therapeutic and diagnostic radioisotopes, while preparing for potential market registration of its targeted radiopharmaceutical pipeline product candidates currently in development.

Garching / Munich, March 16, 2023 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical theranostics company, today announced that the company will present an overview of genetic tumor and blood profiling in its ongoing phase III clinical trial COMPOSE (NCT04919226) in a poster presentation at the 20th Annual European Neuroendocrine Tumor Society (ENETS) Conference held from March 22-24, 2023 in Vienna, Austria, and virtually. COMPOSE evaluates the company’s lead radiopharmaceutical candidate, ITM-11 (n.c.a. 177Lu-edotreotide) compared to standard of care in patients with well-differentiated high grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (G2+G3 SSTR+ GEP-NETs).

Garching/Munich, Munich and Münster, Germany, March 13, 2023 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, Helmholtz Munich and the Departments of Neurosurgery and Nuclear Medicine at the University Hospital Münster today announced the start of a Phase I clinical trial with ITM’s drug candidate ITM-31 (formerly LuCaFab), a novel Targeted Radionuclide Therapy candidate for the treatment of malignant glioblastoma. ITM-31 is a carbonic anhydrase (CA) XII-specific antibody Fab fragment developed by Helmholtz Munich coupled with ITM's medical radioisotope, non-carrier-added lutetium-177 (n.c.a 177Lu, EndolucinBeta®). The investigator-initiated trial (IIT) is sponsored by the University Hospital Münster, conducted in hospitals in Münster, Essen, Cologne, Würzburg, and supported by ITM and Helmholtz Munich. Patient recruitment for the study is ongoing.

Garching / Munich, January 03, 2023 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that CEO Steffen Schuster and CFO Dr. Klaus Maleck will participate in the 41st Annual J.P. Morgan Healthcare Conference in San Francisco. Steffen Schuster will present a corporate overview on Monday, January 9, 2023, at 8:00 am PST.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. www.itm-radiopharma.com

Garching / Munich, October 27, 2022 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for ITM-11 (n.c.a. 177Lu-edotreotide), an investigational radiopharmaceutical for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE.

ONTARIO, CANADA, and MUNICH, GERMANY, October 24, 2022 – An international collaboration between Bruce Power, Isogen (a Kinectrics and Framatome company) and ITM Isotope Technologies Munich SE (ITM), announced today the commencement of commercial production of lutetium-177.   

 Exclusive license from Helmholtz Munich will enable ITM to access IP and know-how to develop and commercialize ITM-31 for glioblastoma patients

Garching / Munich, Germany – October 13, 2022 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the successful completion of a new production line for the medical radioisotope non-carrier-added lutetium-177 (n.c.a. 177Lu) at its production facility IAZ in Garching near Munich. The new production line was inspected and approved by the competent authorities, the government of Upper Bavaria. With this extension, ITM has multiplied its production capacity for its n.c.a. lutetium-177 to meet the growing patient and physician demand and to further strengthen its global market leadership position. N.c.a. lutetium-177 is a therapeutic radioisotope that, when combined with a tumor-specific targeting molecule, can be applied to treat various types of cancers in a highly targeted way.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it will host a scientific symposium on precision oncology titled “Targeted Radionuclide Therapy – present and future prospects” held as an ancillary event in parallel to the 2022 ASCO® Annual Meeting. The symposium will feature key opinion leaders in the field and will be held in a hybrid format on June 03, 2022 from 11:00 am – 12:30 pm CST in the Hyatt Regency McCormick Place, in Chicago, USA and online.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the randomization of the 300th patient and thus the successful completion of patient recruitment in its phase III clinical trial COMPETE, evaluating the efficacy and safety of its lead Targeted Radionuclide Therapy candidate, ITM-11 (n.c.a. 177Lu-edotreotide), in grade 1 and 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Completing patient recruitment is an important milestone demonstrating the progress of the COMPETE study, with which ITM aims to prove the potential of its therapeutic approach to provide added value to patients with GEP-NETs by improving both, treatment outcomes and the patient’s quality of life.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, supports Advanced Accelerator Applications, a Novartis company, as a long-term supplier for the medical radioisotope component of the newly U.S. Food and Drug Administration (FDA) approved radiotherapeutic, PluvictoTM (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. ITM will now supply its medical radioisotope n.c.a. 177Lu (EndolucinBeta®), a core component of the newly approved radiotherapeutic, for the commercial phase based on a supply agreement entered in 2020, supporting the scalability and security-of-supply for patients worldwide.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Grand Pharmaceutical Group Limited (GP), a diversified global pharmaceutical company listed in Hong Kong, today announced that ITM and a subsidiary of GP have entered into a definitive agreement under which GP will make a EUR 25 million (USD 28 million) equity investment in ITM. The agreement will further deepen the strategic collaboration between the two companies and support ITM to further expanding its broad pipeline of precision oncology treatments and diagnostics in Greater China.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the first patient has been treated in its second pivotal phase III clinical trial, COMPOSE (NCT04919226), evaluating the company’s lead radiopharmaceutical candidate, ITM-11 (n.c.a. 177Lu-edotreotide), for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is a Targeted Radionuclide Therapeutic consisting of the high-quality radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) fused with a somatostatin analogue to specifically target somatostatin receptor-positive (SSTR+) GEP-NETs. While COMPOSE is evaluating ITM-11 for the treatment of well-differentiated high grade 2 and grade 3 GEP-NETs, the radiopharmaceutical is also being investigated in ITM’s ongoing pivotal phase III trial, COMPETE (NCT03049189), in patients with grade 1 and 2 GEP-NETs. GEP-NETs are rare types of tumors that can occur in the pancreas or in other parts of the gastrointestinal tract. Due to their frequent asymptomatic and progressive nature, GEP‑NETs often present late with advanced disease requiring innovative therapeutic measures. The trial design of COMPOSE was recently presented at the 2022 ASCO Gastrointestinal Cancers Symposium (ASCO-GI) and the 2021 North American Neuroendocrine Tumor Society (NANETS) annual symposium.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that its partners Bruce Power and Isogen (a partnership between Kinectrics and Framatome) have completed the installation of a groundbreaking Isotope Production System (IPS), becoming the first power reactor in the world with the installed capability to produce Lutetium-177 (Lu-177), a medical isotope used in the treatment of various cancers, such as neuroendocrine tumors and prostate cancer. This system will also have the ability to produce other isotopes for medical uses over the long term.

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Helmholtz Munich (Helmholtz Zentrum München), today announced a cooperation agreement for the clinical development of a radiopharmaceutical therapy candidate to treat malignant brain tumor glioblastoma. ITM and Helmholtz Munich will collaborate to support an upcoming dose-escalation Phase I clinical trial with LuCaFab (ITM-31). LuCaFab is a CA XII-specific antibody Fab fragment targeting molecule, developed by Helmholtz Munich, radiolabeled with ITM’s medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu, EndolucinBeta®). The planned multicenter investigator-initiated trial (IIT) will be led by the Westfälische Wilhelms-Universität Münster (University of Münster, Germany).

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that CEO, Steffen Schuster will present a corporate overview and update at the virtual 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022, at 8am ET (2pm CET).

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Grand Pharmaceutical Group Limited (GP) a diversified global pharmaceutical company listed in Hong Kong, today announced that they have entered into an exclusive licensing agreement for GP to develop, manufacture and commercialize ITM’s oncological radiopharmaceutical candidates, ITM-11 (n.c.a. 177Lu-edotreotide) and ITM-41 (n.c.a. 177Lu-zoledronate) as well as the diagnostic TOCscan® (68Ga-edotreotide) in the territory of mainland China, Hong Kong, Macau and Taiwan.

ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, and the Australian Nuclear Science and Technology Organisation (ANSTO), a public research organization and international leader in the field of nuclear science and technology, today announced the extension of their partnership by entering into a further long-term licensing agreement. Under the terms of the agreement, ANSTO will continue producing n.c.a. 177Lu for the Australian and New Zealand markets by utilizing ITM’s unique production technology, continuing to address the needs of patients, clinicians and partners alike. ITM retains all intellectual property rights to the medical radioisotope. Further details of the agreement were not disclosed.

ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company and Navigo Proteins GmbH, a premier protein engineering company developing optimized scaffold protein-based affinity ligands called Affilin® molecules from its Precision Targeting toolbox, today announced a research collaboration for the development of a fibroblast activation protein (FAP)-targeted radiopharmaceutical program for the treatment of solid tumors. The program is planned to be added to ITM’s growing proprietary pipeline of Targeted Radionuclide Therapies spanning multiple radioisotopes and targeting molecules for optimal therapeutic effect. FAP-Targeted Radionuclide Therapy is a promising new approach to treating cancer within the precision oncology field.

ITM, a leading radiopharmaceutical biotech company, announced today with the registration in the Commercial Register of the District Court of Munich, the completion of its conversion from a German stock corporation (Aktiengesellschaft, “AG”) into a European company (Societas Europaea, “SE”). As of September 21, 2021, ITM is operating under the registered name ITM Isotope Technologies Munich SE (“ITM”) with the commercial register number 269592.