Success with radioactive agents for precision oncology

Since its founding in 2004, ITM Isotope Technologies Munich SE (ITM) has specialized in the development of radiopharmaceutical therapeutics and diagnostics, as well as in the production of the necessary medical radioisotopes. These so-called radiopharmaceuticals consist of two components: a peptide or protein that binds to a specific structure of the target cell, and a radioisotope that releases its radioactive effect within the cell. Radiopharmaceuticals are used in cancer therapy and in diagnostics. target cell, and a radioisotope that exerts its radioactive effect in the cell.  Radiopharmaceuticals are used in cancer therapy and in the diagnosis of certain diseases, where they help imaging techniques to visualize tumors.

“Radiopharmaceuticals are an essential new class of cancer drugs that have the potential to improve treatment outcomes and quality of life for many patients.  With state-of-the-art, highly efficient manufacturing facilities and excellent training, ITM has the knowledge and skills to take on this responsible task and to meet the highest quality and safety standards for patients at all times – with innovative cancer drugs ‘made in Germany’,” says Udo J. Vetter, Chairman of the Supervisory Board, founding investor, and major shareholder of ITM.

The manufacturing process for radiopharmaceuticals is complex and time-critical, as the radioactive active ingredient becomes ineffective after only a short time. Radiopharmaceuticals must therefore be used within a few days of synthesis. ITM operates two production facilities for manufacturing in Garching and Neufahrn near Munich.

"Radiopharmaceuticals are an essential new class of cancer drugs that have the potential to improve treatment outcomes and quality of life for many patients.  With state-of-the-art, highly efficient manufacturing facilities and excellent training, ITM has the knowledge and skills to take on this responsible task and to meet the highest quality and safety standards for patients at all times – with innovative cancer drugs ‘made in Germany’," says Udo J. Vetter, Chairman of the Supervisory Board, founding investor, and major shareholder of ITM.

ITM is currently researching various product candidates that target difficult-to-treat diseases such as brain tumors, lung or ovarian cancer, and neuroendocrine tumors. The most advanced candidate is ITM-11, which targets neuroendocrine tumors that frequently occur in the gastrointestinal tract and pancreas. It consists of the synthetic peptide edotreotide, which binds to tumor-specific receptors, and the medical radioisotope lutetium-177. Its beta radiation is intended to destroy the tumor cells. The drug is administered intravenously and is currently being tested in clinical trials. It consists of the synthetic peptide edotreotide, which binds to tumor-specific receptors, and the medical radioisotope lutetium-177. Its beta radiation is designed to destroy tumor cells in a targeted manner while sparing the surrounding tissue.

ITM recently achieved the most important goal of the Phase 3 COMPETE study with ITM-11. The study data showed a significant improvement in what is known as progression-free survival time – this refers to the period of time during which the patient lives with the disease without it progressing. The biotech company now wants to work quickly towards the potential commercialization of ITM-11 in the US – and to obtain approval from the American Food and Drug Administration (FDA). The financial conditions for this are favorable: In 2023 and 2024, ITM raised around 440 million euros in two financing rounds. In 2025, the company also received a loan of up to $262.5 million from the funds of US investor Blue Owl to prepare for the market launch of ITM-11. The money from Blue Owl will also be used to expand the production of another isotope, actinium 225.

In 2023, ITM opened the world's largest facility for the production of lutetium-177 for targeted radiopharmaceuticals against cancer in Munich-Neufahrn, thereby increasing its production capacity tenfold. Covering an area of around 7,000 m², the new site offers clean rooms, laboratories, and offices that can be used by up to 200 employees for research, radiopharmaceutical manufacturing, and aseptic production with the highest quality standards. At its German sites in Munich-Garching and Munich-Neufahrn, as well as in Princeton, New Jersey, ITM employs around 200 people for research, radiopharmaceutical manufacturing, and aseptic production in accordance with the highest quality standards. At its German locations in Munich-Garching and Munich-Neufahrn, as well as in Princeton, New Jersey (USA), ITM employs a total of more than 800 people from numerous countries.

itm

The aim of ITM is to provide highly precise radiodiagnostics and radiotherapeutics for the identification and treatment of cancers with a high unmet need. The company is leveraging its longstanding radioisotope leadership to build a broad precision oncology pipeline to improve clinical outcomes and quality of life for people living with cancer.

www.itm-radiopharma.com

"With our broad pipeline of new drugs and highly specialized teams in research and development, our leading isotope production capabilities and robust supply chain, and our strong marketing expertise, we are ideally positioned to take a leading role in the dynamically growing radiopharmaceutical industry and actively shape the field of precision oncology,“ emphasizes CEO Dr. Andrew Cavey. ”Our goal is to expand global access to radiopharmaceutical therapies for cancer patients by driving innovation and technology."

All previous CMV drugs were unsuitable for prophylaxis because they attacked not only the virus, but also the human organism. Letermovir, on the other hand, inhibits a viral enzyme that is not present in humans. Phase II clinical trial results published in 2012 showed good tolerability and efficacy for the compound – and piqued Big Pharma’s interest. In October 2012, AiCuris licensed the compound to MSD, the trade name of Merck & Co., Inc., with headquarters in Rahway, N.J., USA, (NYSE: MRK). This deal earned the company €110 million – the largest upfront payment at the time for a research project from the German biotech scene – and potential milestone payments worth an extra €332.5 million.

Editoral: Dr. Claudia Englbrecht englbrecht@biodeutschland.org, Dr. Monika Mölders-Felgenhauer Monika.Moelders@t-online.de