After a recent funding announcement, Isotope Technologies Munich SE (ITM), a radiopharmaceutical biotech company, has opened its new production facility for therapeutic radionuclides in Neufahrn near Munich, Germany.
ITM’s new facility is the world’s largest production site of lutetium-177, an innovative medical isotope used in targeted cancer therapies.
Due to its medical properties, lutetium-177 has gained importance in precision oncology treatments internationally as a valuable starting material for the production of various radiotherapeutics in recent years.
Once the new NOVA production facility is fully operational, Isotope Technologies Munich will increase its capacity to supply clinics, pharmaceutical partners and its own drug pipeline tenfold. This will help Isotope Technologies Munich meet the rapidly growing demand for radiopharmaceuticals used in patient care worldwide.
“With the significant expansion of our production capacities we are solidifying our leading market position while, as the world’s largest manufacturer of n.c.a. lutetium-177, supporting the growth of the radiopharmaceutical industry globally, for which we are a driver and a partner. Together, it is our goal to develop and provide innovative diagnostics and therapeutics for the treatment of cancer patients,” said Steffen Schuster, CEO of Isotope Technologies Munich.
Targeted radionuclide therapy
Targeted radionuclide therapy applies very small amounts of radioactive compounds to diagnose and treat various solid tumor indications. Injected in vivo, radiopharmaceuticals accumulate directly in the affected organ or tumor, largely sparing surrounding healthy tissue.
The high specificity of radiopharmaceutical diagnostics and therapeutics has the potential to detect and target even the smallest tissue changes such as tumor metastases. Due to these properties and its safety profile, targeted radionuclide therapy is already being used for the treatment of various cancers including neuroendocrine tumors (NETs) and certain metastatic prostate tumors.
Financial boost for Isotope Technologies Munich
The news follows on from the announcement of an equity investment round of €255 million ($274.2 million) led by Temasek with participation from BlackRock Alternatives, Qatar Investment Authority (QIA), Nextech, ATHOS and Carbyne.
The round comprised mostly of primary capital alongside a minority transaction of secondary shares. Primary net proceeds to the company will support further development of ITM’s broad Targeted Radionuclide Therapies (TRT) oncology pipeline and enhance commercial readiness as the company nears the final stages of phase III clinical development for its lead pipeline candidate, ITM-11 (n.c.a. 177Lu-edotreotide) in gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In addition, the company will expand its market-leading manufacturing capacities and infrastructure for n.c.a. 177Lu, scale GMP-manufacturing for 225Ac, and expand in-house drug product manufacturing capabilities to accelerate the global access to radiopharmaceuticals worldwide.
Since its inception, Isotope Technologies Munich said it has made progress in delivering on its corporate and clinical goals, namely to advance its lead drug candidate ITM-11 into two phase III clinical trials for GEP-NETs and ITM-31 (Lu-177 labeled 6A10 Fab-fragments) into clinical studies for glioblastoma; to expand production capacity by building a second manufacturing facility in Germany; to open a U.S. headquarters; and to establish a subsidiary in Shanghai, China.
“ITM is a leading radiopharmaceutical company with an advanced proprietary pipeline and has established itself as the major radioisotope supplier globally. This financing supports our objective to serve a broad patient population by ensuring a consistent supply of radionuclides and radiopharmaceuticals to meet the growing demand of medical professionals and our partners across the pharmaceutical, healthcare and research sectors globally,” said Udo J. Vetter, chairman of the supervisory board at Isotope Technologies Munich.
“Securing one of the largest private biotechnology financing rounds ever in our home market from major, globally active investors with deep biotech experience underscores our presence at the forefront of the radiopharmaceutical space on an international scale,” Schuster added.
“As we near the final stages of clinical development for ITM-11 in GEP-NETs, this substantial investment will help to further grow our supply network and accelerate our efforts to bring new, targeted treatments to patients living with hard-to-treat cancers.”
Isotope Technologies Munich also announced that Petrichor’s €90 million ($96.8 million) convertible loan was converted into equity per the terms of that initial agreement.
Last week, Australian company Telix also opened its own radiopharmaceutical production facility in Brussels South, Belgium.
Located in the heart of Belgium’s ‘Radiopharma Valley’, the 2,800-square-meter facility is one of Europe’s largest radiopharmaceutical production facilities. It will serve as the company’s primary manufacturing site for radioisotopes and commercial and clinical products for patients in the Europe Middle East and Africa (EMEA) region and beyond.
“Recent events – including COVID – have taught us that if we are to invest in developing radiopharmaceutical products, we must also invest in ensuring that patients can have access to this new generation of cancer treatments. Given the just-in-time manufacturing and complex logistics required for radiopharmaceuticals, this is vital to building a foundation for long-term, commercial success in our field and delivering to the needs of patients,” said Raphael Ortiz, Telix’s CEO for the EMEA region.
The first stage of the buildout – which is now complete – included installation of nine GMP manufacturing lines, two research and development laboratories, quality control labs and warehousing space with capacity to support Telix’s operations. One of the first GMP lines will be dedicated for the use of industry and research partners and collaborators. The company is also preparing to install the first of two planned cyclotrons for the site.
“Belgium’s ‘Radiopharma Valley’ is a fundamental part of Telix’s innovation success – in fact, the technology that underpins our first commercial product was invented in Belgium. It is our vision that this facility, will not only exist for Telix but operate as a hub for research, development and manufacturing for our partners and collaborators across industry, academia and clinical practice. We are very grateful for the support of the Walloon regional government and AWEX, and hope that this facility will contribute to the ongoing growth of our industry and drive further investment in the region,” Ortiz added.