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History

Targeted Radionuclide Therapies since 2004

Since the foundation of ITM Isotopen Technologien München in 2004, our goal has been to develop and produce next generation radionuclides for tumor therapy. To achieve this, we have been working closely with the Technical University of Munich (TUM) on a range of projects. Over the years, we have set up a very high quality product platform to produce innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals under GMP conditions, especially designed for Targeted Radionuclide Therapy in the field of Precision Oncology.

In 2007, the subsidiary ITG Isotope Technologies Garching was founded, with the aim of developing and producing medical radionuclides. The initial development of the therapeutic radioisotope 90Y was followed by the production of the 188W/188Re Generator and the 225Ac/213Bi Generator for laboratory research.

In 2009, a start was made on the development of the therapeutic radioisotope no-carrier-added 177Lu and a success story took its course – n.ca. 177Lu soon grew to be our lead product under the brand name EndolucinBeta®. In 2010, the production of a new generation, non-metallic 68Ge/68Ga Generator for tumor diagnostics using 68Ga through molecular imaging using PET/CT/MR was started.

To act as a "one stop shop" in the radiopharma branch, we additionally developed all equipment and consumables required for the use and processing of diagnostic and therapeutic radionuclides.

In 2016, we received marketing authorization for our therapeutic radiopharmaceutical precursor EndolucinBeta® (n.c.a. 177Lu Chloride) and the next strategic steps were taken – from being purely a provider of radionuclides to being a radiopharmaceutical enterprise. In 2017 ITM’s subsidiary ITM Solucin started an international phase III clinical trial, known as COMPETE, with the lead candidate Solucin® (n.c.a. 177Lu-Edotreotide). Solucin® is a therapeutic radiopharmaceutical for the treatment of gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) based on EndolucinBeta®.

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 treatments of NETs. TOCscan® is the companion diagnostic to Solucin® and a ready to use radiopharmaceutical which creates 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 and laying the cornerstone for it’s first  U.S. facility, based in North Carolina. With strong and reliable partners, ITM is expanding it’s Precision Oncology pipeline and is developing promising candidates in different indications, for example the partnership with Merck Darmstadt for the development of Folate Receptor Targeted Radionuclide Therapy. Further interesting candidates in several indications will follow.