ITM Isotope Technologies Munich SE

ITM Presents Design of Second Phase III Trial, COMPOSE, with Radiopharmaceutical ITM-11 for the Treatment of Neuroendocrine Tumors at Annual ENETS Conference 2022

Retrieved on: 
Wednesday, March 9, 2022

The study is designed to evaluate the efficacy and safety of ITMs lead radiopharmaceutical candidate, ITM-11 (n.c.a.

Key Points: 
  • The study is designed to evaluate the efficacy and safety of ITMs lead radiopharmaceutical candidate, ITM-11 (n.c.a.
  • 177Lu-edotreotide), compared to best standard of care for patients with welldifferentiated high grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (G2+G3 SSTR+ GEP-NETs).
  • We value the opportunity to present our second phase III trial to the expert ENETS community as we continue advancing our lead candidate through the clinic.
  • COMPOSE builds upon ITMs first ongoing phase III clinical trial, COMPETE ( NCT03049189 ), examining patients with grade 1 and grade 2, GEP-NETs.

ITM Announces First Patient Treated in Second Phase III Trial, COMPOSE, with ITM-11 (n.c.a. 177Lu-edotreotide) for Treatment of Neuroendocrine Tumors

Retrieved on: 
Tuesday, January 25, 2022

177Lu-edotreotide), for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Key Points: 
  • 177Lu-edotreotide), for the treatment of gastroenteropancreatic neuroendocrine tumors (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, GEPNETs 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: Installation of New Isotope Production System at Bruce Power to Produce Medical Isotopes for Cancer Therapy Completed

Retrieved on: 
Monday, January 24, 2022

This system will also have the ability to produce other isotopes for medical uses over the long term.

Key Points: 
  • This system will also have the ability to produce other isotopes for medical uses over the long term.
  • Ontario is leading the way in the production and supply of medical isotopes around the world, said Hon.
  • Im proud of the innovative work being done by Bruce Power and its partners in the supply chain, including Framatome and Kinectrics.
  • Isogens enabling partnerships with Bruce Power and ITM allows us to produce the worlds largest and most reliable supply of life-saving, short-lived, therapeutic medical isotopes.

ITM Presents Study Design of COMPOSE Phase III Trial with ITM-11 (n.c.a. 177Lu-edotreotide) for Treatment of Neuroendocrine Tumors at ASCO-GI

Retrieved on: 
Wednesday, January 19, 2022

177Lu-edotreotide), compared to best standard of care in patients with welldifferentiated high grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (G2+G3 SSTR+ GEP-NETs).

Key Points: 
  • 177Lu-edotreotide), compared to best standard of care in patients with welldifferentiated high grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (G2+G3 SSTR+ GEP-NETs).
  • COMPOSE is ITMs second phase III trial with ITM-11 following and building upon COMPETE ( NCT03049189 ), in patients with grade 1 and grade 2 GEP-NETs.
  • The primary endpoint of the study is progression-free survival (PFS), which will be assessed every 12 weeks from randomization onwards.
  • As such, I look forward to investigating its potential for patients with advanced GEP-NETs as we move ITM-11 through this Phase III trial.

ITM and Helmholtz Munich Sign Cooperation Agreement for the Clinical Development of Radiopharmaceutical Therapy to Treat Glioblastoma Multiforme

Retrieved on: 
Thursday, January 13, 2022

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Helmholtz Munich (Helmholtz Zentrum Mnchen) , today announced a cooperation agreement for the clinical development of a radiopharmaceutical therapy candidate to treat malignant brain tumor glioblastoma.

Key Points: 
  • ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Helmholtz Munich (Helmholtz Zentrum Mnchen) , 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).
  • Steffen Schuster, CEO of ITM comments: We are pleased to continue our collaboration with Helmholtz Munich and to further advance ITMs clinical pipeline.
  • Helmholtz Munich has more than 2,500 employees and is headquartered in Neuherberg, north of Munich.

ITM and Navigo Proteins Announce Research Collaboration to Develop FAP-targeting Radionuclide Therapy to Address Solid Tumors

Retrieved on: 
Thursday, December 2, 2021

FAP-Targeted Radionuclide Therapy is a promising new approach to treating cancer within the precision oncology field.

Key Points: 
  • FAP-Targeted Radionuclide Therapy is a promising new approach to treating cancer within the precision oncology field.
  • Following candidate selection, ITM will have the exclusive rights to further advance the radiolabeled FAP-specific Affilin through clinical testing in potentially multiple cancer indications.
  • ITM and Navigo are addressing this urgent need through their research collaboration and combined efforts to develop a promising FAP-targeted radiopharmaceutical.
  • By joining forces with ITM, we are fully equipped to build a strong FAP-targeting candidate, that ITM will then advance through clinical development, said Henning Afflerbach, CEO of Navigo Proteins.

ITM Introduces Second Phase III Trial, COMPOSE, with n.c.a. 177Lu-edotreotide for Neuroendocrine Tumors at NANETS Annual Symposium 2021

Retrieved on: 
Wednesday, November 3, 2021

177Lu-edotreotide in patients with welldifferentiated aggressive grade 2 and grade 3 somatostatin receptor-positive gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) at the North American Neuroendocrine Society (NANETS) annual symposium 2021, held virtually from November 3 6, 2021.

Key Points: 
  • 177Lu-edotreotide in patients with welldifferentiated aggressive grade 2 and grade 3 somatostatin receptor-positive gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) at the North American Neuroendocrine Society (NANETS) annual symposium 2021, held virtually from November 3 6, 2021.
  • COMPOSE is ITMs second phase III trial with its lead candidate n.c.a.
  • 177Lu-edotreotide is also currently being investigated in an ongoing phase III study, COMPETE, in patients with grade 1 and 2 GEP-NETs.
  • For more information on COMPOSE and ITM, visit the ITM virtual booth at the NANETS virtual industry exhibition.

Clovis Oncology and ITM Announce Lutetium-177 Clinical Supply Agreement

Retrieved on: 
Tuesday, October 19, 2021

Clovis Oncology, Inc. (NASDAQ: CLVS) and ITM Isotope Technologies Munich SE , a leading radiopharmaceutical biotech company, today announced the signing of a clinical supply agreement that provides Clovis Oncology with ITMs therapeutic radioisotope no-carrier-added Lutetium-177 (n.c.a.

Key Points: 
  • Clovis Oncology, Inc. (NASDAQ: CLVS) and ITM Isotope Technologies Munich SE , a leading radiopharmaceutical biotech company, today announced the signing of a clinical supply agreement that provides Clovis Oncology with ITMs therapeutic radioisotope no-carrier-added Lutetium-177 (n.c.a.
  • 177Lu), EndolucinBeta, for use in the clinical development of FAP-2286, Clovis fibroblast activation protein (FAP)-targeting therapeutic candidate.
  • Clovis Oncology is committed to advancing FAP-2286s clinical development program and emerging as a leader in targeted radionuclide therapy.
  • A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement allows us to achieve that goal, said Patrick Mahaffy, President and CEO of Clovis Oncology.

ITM and CNL Sign Memorandum of Understanding to Pursue Global Development and Production of Rare Medical Radioisotope, Actinium-225

Retrieved on: 
Monday, October 18, 2021

Under the terms of the agreement, the organizations will collaborate on the development, manufacturing, and distribution pathways for the medical radioisotope.

Key Points: 
  • Under the terms of the agreement, the organizations will collaborate on the development, manufacturing, and distribution pathways for the medical radioisotope.
  • ITM is a world leader in the development, production and global supply of radiotherapeutics and diagnostics, and maintains an evolving precision oncology pipeline.
  • Under the terms of the agreement, CNL will be responsible for the research and development as well as the production of Actinium-225.
  • CNL and ITM aim to leverage their capabilities towards establishing a continuous commercial supply of GMP-grade Actinium-225 for the global market.

ITM Announces Completion of Conversion into SE

Retrieved on: 
Wednesday, September 22, 2021

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).

Key Points: 
  • 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.
  • The SE corporate form provides ITM with benefits designed to meet the needs of European-based companies that operate internationally.
  • We view this conversion as a logical step as we continue to develop as an organization, commented Steffen Schuster, CEO of ITM.