LuCaFab (ITM-31) / ITM Isotope Technologies Munich, German Research Center for Environmental Health - LARVOL DELTA

RIT in GBM: Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: University Hospital Muenster | N=15 ➔ 10

Enrollment change • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

RIT in GBM: Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: University Hospital Muenster | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2026 ➔ Oct 2027 | Trial primary completion date: Apr 2026 ➔ Oct 2026

Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

RIT in GBM: Radioimmunotherapy with Lu-177 Labeled 6A10 Fab-fragments in Patients with Glioblastoma After Standard Treatment (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: University Hospital Muenster | Trial completion date: Jun 2025 ➔ Apr 2026 | Trial primary completion date: Jun 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

ITM, Helmholtz Munich and University Hospital Münster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial (GlobeNewswire) - "The Departments of Neurosurgery and Nuclear Medicine at the University Hospital Münster, Helmholtz Munich, and ITM Isotope Technologies Munich SE (ITM)...announced that the first patient has been dosed in an investigator-initiated trial (IIT) with ITM’s radiopharmaceutical drug candidate, ITM-31 for the potential use in glioblastoma patients. The IIT is sponsored by the University Hospital Münster, conducted in hospitals in Münster, Essen, Cologne, and Würzburg, and supported by Helmholtz Munich and ITM."

Trial status • Glioblastoma

RIT in GBM: Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: University Hospital Muenster | Trial completion date: Dec 2023 ➔ Jun 2025 | Trial primary completion date: Sep 2023 ➔ Jun 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

ITM Announces €255m Investment Round, Plans to Advance Radiopharmaceutical Pipeline and to Expand Radioisotope Production Capacities (GlobeNewswire) - "ITM Isotope Technologies Munich SE...announced an equity investment round of €255 million led by Temasek with participation from BlackRock Alternatives, Qatar Investment Authority (QIA), Nextech, ATHOS and Carbyne...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...ITM has made substantial progress in delivering on its ambitious corporate and clinical goals...Advancing 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."

Financing • Pipeline update • Gastrointestinal Cancer • Glioblastoma • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

RIT in GBM: Radioimmunotherapy With Lu-177 Labeled 6A10 Fab-fragments in Patients With Glioblastoma After Standard Treatment (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: University Hospital Muenster | Initiation date: Oct 2022 ➔ Jun 2023

Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

ITM, Helmholtz Munich and University Hospital Münster Announce Start of Phase I Clinical Trial with Radiotherapeutic ITM-31 for Glioblastoma (GlobeNewswire) - "ITM Isotope Technologies Munich SE (ITM)...Helmholtz Munich and the Departments of Neurosurgery and Nuclear Medicine at the University Hospital Münster today announced the start of a Phase I clinical trial with ITM’s drug candidate ITM-31 (formerly LuCaFab), a novel Targeted Radionuclide Therapy candidate for the treatment of malignant glioblastoma."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

ITM Executes Option to In-license Targeted Radionuclide Therapy Candidate LuCaFab (ITM-31) for the Treatment of Malignant Brain Tumors (GlobeNewswire) - "ITM Isotope Technologies Munich SE (ITM)...announced the execution of an exclusive licensing option for LuCaFab (now ITM-31), a novel Targeted Radionuclide Therapy candidate for the treatment of malignant glioblastoma....The exclusive license from Helmholtz Munich is based on the option and cooperation agreements announced in January 2022, which the partners entered into with the goal of advancing ITM-31 into clinical development. Under the terms of the license agreement, ITM will hold exclusive rights to the compound ITM-31 as well as the rights to related patents and know-how for the manufacturing and use of ITM-31."

Licensing / partnership • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor