Latest news with #Garching
Associated Press
23-06-2025
- Business
- Associated Press
ITM and Debiopharm Announce First Patient Imaged in New Study Arm of Phase 1/2 Trial Evaluating ITM-94 as Diagnostic Agent for Clear Cell Renal Cell Carcinoma (ccRCC)
Garching / Munich, Germany, and Lausanne, Switzerland - June 23, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm, a Swiss-based, global biopharmaceutical company aiming to establish tomorrow's standard-of-care to cure cancer and infectious diseases, today announced that the first patient was imaged in a new study arm of a five-part, Phase 1/2 clinical trial (formerly GaLuCi™) (NCT05706129) evaluating the theranostic pair ITM-94/ITM-91 for identification and treatment of patients who have unresectable, locally advanced or metastatic solid tumors. As a new component of a broad clinical development plan for ITM-91/ITM-94, Part D of the trial will evaluate the effectiveness of ITM-94 in classifying indeterminate renal mass as either ccRCC or non-cancerous. ITM-91/ITM-94 is a first-in-class, peptide-based theranostic pair combining the radiotherapeutic compound ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452), with the diagnostic agent ITM-94 (Debio 0328) ([68Ga]Ga-DPI-4452) to target Carbonic Anhydrase IX (CAIX). CAIX is a cell surface protein that plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. In September 2024, ITM gained the exclusive worldwide license from Debiopharm for the development and commercial rights of ITM-91/ITM-94. The initiation of this study arm represents a significant advancement for ITM and Debiopharm following their licensing agreement. In the now initiated Part D of the trial, ITM-94 is being evaluated for its effectiveness to accurately classify an indeterminate renal mass as ccRCC or non-cancerous, when compared to CT/MRI imaging and histopathology. Secondary endpoints include sensitivity, specificity, and the positive and predictive value of ITM-94 PET/CT imaging compared to histopathology. This study arm is expected to enroll approximately 36 patients at around 15 clinical sites across the EU, US and Australia. ' The early results from the Gallium-68 CAIX PET/CT diagnostic are remarkable to date. I believe ITM-94 has the potential to change the way urologists and oncologists diagnose and stage patients with clear cell renal cell carcinoma, improving accuracy and reducing the need for biopsies. I have not seen a tracer with a similar profile since the PSMA PET/CT was established,' added Prof. Michael Hofman, Director, Prostate Cancer Theranostics and Imaging Centre of Excellence (ProSTIC), Peter MacCallum Cancer Centre, Melbourne, Australia. ' Clear cell renal cell carcinoma is the most common form of kidney cancer, with more than 90% of cases overexpressing the CAIX encoding gene. As survival rates are highly dependent on the stage of progression, rapid and precise diagnosis is essential to provide patients with the best possible treatment options and therapeutic outcomes. ITM-94 has already demonstrated potential exceptional imaging qualities, including high tumor-to-background ratios and detecting lesions not visible by CT scan with a potential favorable safety profile. We look forward to exploring the full potential of the theranostic pair ITM-91/ITM-94 across this trial to characterize and treat CAIX expressing cancer cells, advancing the efficacy of targeted radiopharmaceutical therapies,' said Dr. Celine Wilke, Chief Medical Officer of ITM. ' With high-quality imaging and high tumor uptake, ITM-94 has already demonstrated potentially significant diagnostic capabilities in solid tumors. The data gathered in Part D of the trial will be instrumental to the further validation of this theranostic pair. We highly value our partnership with ITM, which will continue to advance the rapid progression of these novel radio-diagnostics and -therapeutics through the clinic,' said Angela Zubel, Chief Development Officer, Research & Development at Debiopharm. About the Phase 1/2 ITM-91/ITM-94 Trial The five-part clinical trial (NCT05706129) is designed to assess the safety and tolerability, imaging characteristics, and efficacy of the theranostic pair ITM-91/ITM-94 in patients with unresectable, locally advanced or metastatic solid tumors. In Part A of the trial, ITM-94 demonstrated exceptional tumor imaging characteristics, with a high tumor-to-background ratio and a favorable tolerability profile in patients with confirmed ccRCC, with results published in the Journal of Nuclear Medicine. Part B, which is ongoing, is assessing escalating doses of the therapeutic agent, ITM-91, in patients whose tumors show high uptake of the imaging tracer. Based on the recommended dose from Part B, Part C of the trial will assess the safety and preliminary efficacy of ITM-91 in patients with ccRCC, pancreatic ductal adenocarcinoma, colorectal cancer, urothelial carcinoma and potentially other tumor types. In addition to the newly initiated Part D, Part E will assess ITM-94 uptake in other tumors. ITM will assume full sponsorship of the program from Debiopharm once the transfer is completed. About ITM-91/ITM-94 (Debio 0228/ 0328) ITM-91/ITM-94 is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and now exclusively licensed to ITM. ITM-94 ([68Ga]Ga-DPI-4452) is a PET imaging agent that may be used independently and is designed to identify patients whose cancers overexpress CAIX. Once identified, these patients may be treated with the lutetium-labelled radioligand, ITM-91 ([177Lu]Lu-DPI-4452), which delivers targeted radiation to the tumor with the aim to destroy it from the inside. About ITM Isotope Technologies Munich SE ITM, 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. Debiopharm's commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then select large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit We are on X. Follow us @DebiopharmNews at or on LinkedIn. 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] Debiopharm Contact Dawn Bonine - Head of Communications [email protected] Tel: +41 (0)21 321 01 11 Attachment
Yahoo
18-06-2025
- Science
- Yahoo
Space photo of the day for June 17, 2025
When you buy through links on our articles, Future and its syndication partners may earn a commission. Big telescopes feature some of the finest and most precise mirrors in the world. So when one gets dirty, what happens? The European Southern Observatory (ESO) operates some of the most powerful telescopes in the world. Established in 1962 by 16 countries across the globe, the ESO is a hub for astronomers looking to uncover the mysteries of our universe. The observatory hosts four extremely powerful telescopes, which are used to survey the farthest corners of our galaxy, studying a variety of space structures and phenomena, from black holes to stars to asteroids. While ESO's headquarters are in Garching, Germany, its four telescopes all sit in the Atacama Desert in Chile (hence the "Southern" part of ESO name). This photo was taken at the La Silla Observatory in Chile. ESO hosts four different telescopes in Chile: the Very Large Telescope (VLT), the Atacama Large Millimeter/submillimeter Array (ALMA), the Extremely Large Telescope (ELT, which is currently being built), and La Silla, the subject of this photo. While all four facilities focus on solving the mysteries of space, La Silla is centered specifically on finding exoplanets. Its two telescopes, the 11.5-foot (3.5 meters) New Technology Telescope (NTT) and the 11.8-foot (3.6 m) telescope both use ultraprecise mirrors to bounce images back from space for analysis. In this photo, staff at La Silla work to clean the 11.8-foot telescope's primary mirror. As the mirror was made with fused silica, it takes a delicate process to restore it to a clean, ultraprecise state. Staff have to chemically strip the mirror's old aluminum coating before rinsing it with demineralized water. The mirror then goes into a special vacuum chamber, where aluminum is deposited in a new layer thinner than the width of a human hair. If the aluminum layer were too thick or uneven, the mirror would lose its precision and with it, data from space. You can read more about ESO's many telescopes and their work looking at exoplanets and other structures within our universe.
Associated Press
16-06-2025
- 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
Yahoo
16-06-2025
- 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
Yahoo
13-06-2025
- Business
- Yahoo
ITM to Provide COMPETE Trial Insights at SNMMI 2025 Annual Meeting in Oral Presentation and Satellite Symposium
Garching / Munich, Germany, June 13, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it will provide further analysis from its recently completed Phase 3 COMPETE trial in an oral presentation and Satellite Symposium at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, held from June 21 – June 24, 2025 in New Orleans, Louisiana. Details of the Oral PresentationThe data will be presented by Dr. Thomas A. Hope, MD, Chief of Nuclear Medicine at the San Francisco VA Medical Center and Vice Chair of Clinical Operations and Strategy in the Department of Radiology at UCSF in an oral presentation titled, 'Predicting the [177Lu]Lu-edotreotide uptake in tumors using pre-therapeutic Ga-68 PET/CT imaging', on Sunday, June 22 in the Neuroendocrine - Oncology Clinical Diagnosis and Therapy session from 3:30 – 4:45 pm CDT. The presentation will provide an analysis on the 177Lu-edotreotide tumor uptake and its predictability based on pre-therapeutic SSTR PET/CT imaging and other factors. Symposium DetailsThe symposium, 'Pursuing the Art and Science of RPT: COMPETE Results and the Evolution of Dosimetry,' will take place on Sunday June 22, from 6:30 pm – 7:30 pm CDT. The symposium will feature an overview of the GEP-NET treatment landscape, including findings from the Phase 3 COMPETE trial, and perspectives on dosimetry standardization today and in the future. COMPETE evaluated n.c.a 177Lu-edotreotide (also known as ITM-11) in patients with grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) and ITM announced the positive Phase 3 results in March 2025. Date and Time: Sunday, June 22, from 6:30 pm – 7:30 pm CDTLocation: Ernest N. Morial Convention Center, New Orleans, LA; Room R04-R05Speakers and Topics: GEP-NET treatment landscape, COMPETE trial results, and COMPOSE trial designJonathan Strosberg, MD; Section Head, Neuroendocrine Division Program Chair, Gastrointestinal Department Oncology Research Program Moffitt Cancer Center COMPETE dosimetry sub-study and the evolution of dosimetryJohn Sunderland, PhD; Professor of Radiology Nuclear Medicine Division University of Iowa Dr. Celine Wilke Participates in Entrepreneur's PanelAs part of the SNMMI conference, Dr. Celine Wilke, ITM's Chief Medical Officer will participate in the 'Entrepreneur's Panel: Community Based Sites – Accelerating Clinical Trials and Expanding Access,' on Saturday, June 21, from 3:30 – 4:45 pm will further be present at the conference with a booth (booth number: 1001) providing information on the company's latest innovations in radiopharmaceutical therapy (RPT), its pipeline of RPT therapeutics and the company's capabilities to produce high-quality medical radioisotopes for global partners and its own pipeline. About the COMPETE TrialThe COMPETE trial evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. 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 of medical radioisotopes. 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. ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@ Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@ Attachment 20250613_ITM to Provide COMPETE Trial Insights at SNMMI 2025 Annual Meeting in Oral Presentation and Satellite Symposium
