ITM, Helmholtz Munich and the University of Münster Announce Updated Preliminary Phase 1 Data with ITM-31 in Glioblastoma Patients

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Garching/Munich and Münster, Germany - June 29, 2026 - ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, Helmholtz Munich and the University of Münster today announced updated preliminary results from a Phase 1 clinical trial of investigational candidate, ITM-31 ( 177 Lu-6A10-Fab), an intracavitary targeted radiotherapy, in patients with glioblastoma. These data showed a manageable safety profile, with all patients remaining alive since enrollment began in January 2024. Enrollment is now complete, and the initial six-month follow-up period for all patients is expected to be completed by the end of 2026. Preliminary data were recently presented at the Nuclear Medicine and Neuro-Oncology (NMN) Society Annual Symposium, in Vienna, Austria. The investigator-initiated Phase 1 trial (NCT05533242) is a prospective, single-arm, multicenter, dose-escalation study evaluating the safety, tolerability, and maximum tolerated dose of ITM-31, as well as progression-free survival (PFS) and overall survival (OS) in patients with newly diagnosed glioblastoma, following surgical resection and standard radio-chemotherapy, with no or minimal residual disease. ITM-31 is designed as a maintenance therapy applied during a period of stability. The study enrolled ten patients across four clinical sites at German university hospitals in Münster, Würzburg, Essen, and Cologne. ITM-31 is a Lutetium-177-labeled 6A10 Fab fragment targeting carbonic anhydrase XII (CA XII), a cell surface protein expressed in more than 90% of glioblastoma cases but absent in healthy brain tissue. It is administered via intracavitary injection directly into the post-surgical resection cavity, enabling targeted radiation of residual tumor cells, bypassing the blood–brain barrier. Under a licensing agreement with Helmholtz Munich, ITM holds exclusive rights to develop and commercialize ITM-31. “By delivering ITM-31 directly into the surgical resection cavity, our goal is to achieve high targeted radiation exposure at the site of residual disease, while minimizing systemic toxicity,” said Dr. Michael Müther , study investigator and neurosurgeon at the University of Münster . “Given the disease’s high rate of recurrence, strategies that address residual tumor cells locally may play an important role in improving outcomes.” “We have come a long way from validating our antibody in the first cell assays to bringing it into the clinic. It has been a wonderful experience to partner with the University of Münster and ITM for this first study, and we are hopeful that this approach may ultimately benefit patients with glioblastoma,” said Prof. Reinhard Zeidler, group leader at the Institute of Structural Biology, Molecular Targets and Therapeutics Center, Helmholtz Munich , who identified and developed the CA XII-targeting 6A10 antibody fragment used in ITM-31. Study design: