From a Radioisotope Supplier to a Biotechnology and Radiopharmaceutical Group of Companies

Since the foundation of ITM Isotope Technologies Munich SE in 2004, our goal has been to develop and produce a new generation of Targeted Radionuclide Diagnostics and Therapies in Precision Oncology. Therefore, we have been working closely with the Technical University of Munich (TUM) on a range of projects. Over the years, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of innovative, first-in-class medical radioisotopes and generator platforms for a new generation of targeted cancer diagnostics and therapies.

In 2007, the subsidiary ITM Medical Isotopes GmbH (formerly: ITG Isotope Technologies Garching GmbH) was founded, with the aim to develop and produce diagnostic and therapeutic radioisotopes. In 2009, we developed our lead product, the highly pure therapeutic radioisotope no-carrier-added Lutetium-177, for which we received marketing authorization in 2016. N.c.a. ¹⁷⁷Lu is also known under the brand name EndolucinBeta^®. In 2010, the production of the new generation, non-metallic Germanium-68/Gallium-68 Generator producing Gallium-68 for tumor diagnostics via molecular imaging with PET/CT/MR began. To act as a "one stop shop" in the radiopharmaceutical field, we additionally produce all the Radiolabeling & Quality Control Equipment required for the use and processing of diagnostic and therapeutic radioisotopes, such as labeling modules and quality control solutions.

Taking next strategic steps from being a provider of medical radioisotopes to being a biotechnology and radiopharmaceutical group of companies, ITM’s subsidiary ITM Solucin GmbH started an international Phase III Clinical Trial, known as COMPETE, in 2017. COMPETE is evaluating the efficacy and safety of Targeted Radionuclide Therapy with n.c.a. ¹⁷⁷Lu-Edotreotide, a therapeutic radiopharmaceutical for the treatment of gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) based on EndolucinBeta^®, compared to the standard therapy.

By adding TOCscan^® (⁶⁸Ga-Edotreotide) to our product platform in 2018, ITM took a further important step in leading the way towards a new generation of theranostic agents for NETs. TOCscan^® is the diagnostic companion to n.c.a. ¹⁷⁷Lu-Edotreotide and a ready to use radiopharmaceutical which ensures high-quality PET images. Marketing authorization is held in Germany, Austria, and France.

ITM is currently pursuing a strong growth strategy including signing several large-scale radioisotope production and supply agreements as well as opening new production sites. With strong and reliable partners we are expanding our Precision Oncology Pipeline and are developing new promising candidates in various indications such as neuroendocrine tumors, glioblastoma, osteosarcoma and bone metastases, as well as folate receptor α positive tumors such as lung, ovarian or breast cancer.

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