Garching (Munich U-Bahn)

ITM to Present at the 41st Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Tuesday, January 3, 2023

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.

Key Points: 
  • 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.

ITM Receives FDA Fast Track Designation for Radionuclide Therapy Candidate ITM-11 (n.c.a. 177Lu-edotreotide) in Neuroendocrine Tumors (GEP-NETs)

Retrieved on: 
Thursday, October 27, 2022

ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE .

Key Points: 
  • ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE .
  • The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need.
  • The Fast Track designation enables ITM to have more frequent interactions with the FDA to discuss the ITM-11 development path.
  • The rolling submission will allow ITM to submit completed sections of an application for review by FDA, rather than wait until all sections are completed.

ITM Executes Option to In-license Targeted Radionuclide Therapy Candidate LuCaFab (ITM-31) for the Treatment of Malignant Brain Tumors

Retrieved on: 
Wednesday, October 19, 2022

Garching/Munich, Germany, October 19, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the execution of an exclusive licensing option for LuCaFab (now ITM-31), a novel Targeted Radionuclide Therapy candidate for the treatment of malignant glioblastoma.

Key Points: 
  • Garching/Munich, Germany, October 19, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the execution of an exclusive licensing option for LuCaFab (now ITM-31), a novel Targeted Radionuclide Therapy candidate for the treatment of malignant glioblastoma.
  • Glioblastoma is one of the most malignant types of primary brain tumors.
  • Glioblastoma cells can selectively express certain surface antigenic proteins such as CA XII, which are not found on healthy brain cells.
  • ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors.

ITM Multiplies Production Capacity for its n.c.a. Lutetium-177

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Thursday, October 13, 2022

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.

Key Points: 
  • 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.
  • 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.
  • ITM plans to further expand its current production area of over 900 mby another 4600 m at the new production site currently being built in Neufahrn, close to ITMs headquarters.

ITM and BAMF Health Enter Global Cooperation Agreement for Targeted Radiopharmaceuticals in U.S. Radiopharmacy and Clinic Network

Retrieved on: 
Thursday, September 8, 2022

The leading state-of-the-art facility of BAMF's theranostic network opened this month in Grand Rapids, Michigan.

Key Points: 
  • The leading state-of-the-art facility of BAMF's theranostic network opened this month in Grand Rapids, Michigan.
  • ITM will contribute its deep understanding of the development, production and global supply of its high-quality diagnostic and therapeutic radioisotopes.
  • BAMF Health is achieving Intelligence-Based Precision Medicine through Artificial Intelligence enabled Molecular Imaging and Molecular Targeted Radiation Therapy.
  • The location includes the worlds most advanced cyclotron-equipped Radiopharmacy, Molecular Imaging Clinic, and Theranostic (Molecular Therapy) Clinic.

ITM to Present Trial Design of Ongoing Phase III COMPOSE Study in Advanced Neuroendocrine Tumors at ESMO 2022

Retrieved on: 
Tuesday, September 6, 2022

Garching / Munich, September 6, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company,today announced that a scientific poster on the design of its second phase III clinical trial, COMPOSE, in advanced neuroendocrine tumors (GEP-NETs) will be presented at the upcoming ESMO Congress from September 9-13, 2022, in Paris.

Key Points: 
  • Garching / Munich, September 6, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company,today announced that a scientific poster on the design of its second phase III clinical trial, COMPOSE, in advanced neuroendocrine tumors (GEP-NETs) will be presented at the upcoming ESMO Congress from September 9-13, 2022, in Paris.
  • The start of patient treatment in the pivotal COMPOSE trial was announced in January this year .
  • COMPOSE ( NCT04919226 ) is designed to evaluate the efficacy and safety of ITMs lead candidate, ITM-11 (n.c.a.
  • 177Lu-edotreotide), as first- or second-line treatment compared to best standard of care for patients with well-differentiated aggressive grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

ITM Acquires a New Platform for the Development of Next-Generation Theranostics

Retrieved on: 
Thursday, August 18, 2022

By extending our diagnostic and therapeutic portfolio, ITM consequently pursues the theranostic concept of molecular precision oncology.

Key Points: 
  • By extending our diagnostic and therapeutic portfolio, ITM consequently pursues the theranostic concept of molecular precision oncology.
  • The acquisition gives ITM access to a DATA chelator-based platform technology leveraging gallium-68 (68Ga) as the fastest growing PET radionuclide to develop new targeted PET solutions.
  • 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.

ITM Appoints Dr. Sebastian Marx as Chief Business Officer and Member of Executive Board

Retrieved on: 
Friday, July 22, 2022

Garching / Munich, July 22, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Dr. Sebastian Marx to its Executive Board as Chief Business Officer (CBO) of the ITM Group.

Key Points: 
  • Garching / Munich, July 22, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the appointment of Dr. Sebastian Marx to its Executive Board as Chief Business Officer (CBO) of the ITM Group.
  • Dr. Marx joined ITM in 2008 and has since contributed significantly to the companys growth and development across various product management positions, including Head of Sales.
  • We appreciate Sebastians accomplishments over the past 14 years at ITM and warmly welcome him to the Board.
  • The Executive Board of ITM now consists of Steffen Schuster, CEO, Dr. Klaus Maleck, CFO, and Dr. Sebastian Marx, CBO.

ITM Signs Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177

Retrieved on: 
Thursday, July 21, 2022

ITM to supply its medical radioisotope, no-carrier-added Lutetium-177, for the clinical development of Y-mAbs Targeted Radionuclide Therapy candidate GD2-SADA: 177Lu-DOTA Complex for GD2-positive solid tumors

Key Points: 
  • ITM to supply its medical radioisotope, no-carrier-added Lutetium-177, for the clinical development of Y-mAbs Targeted Radionuclide Therapy candidate GD2-SADA: 177Lu-DOTA Complex for GD2-positive solid tumors
    Garching / Munich, Germany, July 21, 2022 ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today announced the signing of a clinical supply agreement for its medical radioisotope no-carrier-added lutetium-177 (n.c.a.
  • Under the terms of the agreement, ITM will provide its n.c.a.
  • 177Lu for the clinical development of Y-mAbs radiopharmaceutical candidate GD2-SADA: 177Lu-DOTA Complex.
  • The agreement was executed between Y-mAbs and ITMs wholly owned subsidiary ITM Pharma Solutions GmbH.

ITM to Host Symposium on Actinium-225 Targeted Radionuclide Therapy and to Present Phase III COMPOSE Trial Design at the Theranostics World Congress

Retrieved on: 
Wednesday, June 15, 2022

The symposium titled, Actinium-225 Targeted Radionuclide Therapy Current Perspective and Future Outlooks will take place on June 25, from 11:30 am to 12:55 pm CET.

Key Points: 
  • The symposium titled, Actinium-225 Targeted Radionuclide Therapy Current Perspective and Future Outlooks will take place on June 25, from 11:30 am to 12:55 pm CET.
  • Participants can attend in person or join via live stream, which will be available on the TWC website ahead of the congress.
  • The COMPOSE trial design poster (#55) will be presented during the coffee and lunch breaks from June 24 26, 2022.
  • ITM-11 is a Targeted Radionuclide Therapy consisting of the high-quality beta-emitting radioisotope, no-carrier-added lutetium-177 (n.c.a.