The investigator initiated, multicenter phase I trial is designed to evaluate the safety, tolerability and efficacy of LuCaFab and to establish the dosing scheme for future studies. It is sponsored by the University of Münster, conducted in hospitals in Münster, Essen, Cologne and Würzburg, and supported by Helmholtz Munich and Isotope Technologies Munich (ITM). LuCaFab is an antibody-fragment targeting carbonic anhydrase (CA) XII, coupled with ITM’s highly pure medical radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu, EndolucinBeta®).
The candidate has strong potential to improve the prognosis of patients suffering from glioblastoma, one of the most malignant and difficult-to-treat brain tumours. With standard therapies, median survival is currently only 16 to 18 months after diagnosis, mainly due to residual tumour cells that have spread into surrounding tissues. Following surgery, they can regrow and eventually lead to tumour relapse. LuCaFab will be applied directly into the tumour cavity resulting from surgery to deliver its toxic load specifically to residual glioblastoma cells. Because normal brain cells do not express Ca XII and the n.c.a. 177Lu radioisotope has a very short penetration range, healthy tissues will largely be spared.
The therapeutic target and specific antibody fragment originate from the work of Prof. Reinhard Zeidler, who is a professor at the ENT department of the LMU Klinikum and a group leader at Helmholtz Munich. Together with experts at the LMU Klinikum, including Prof. em. Hans-Jürgen Reulen (Neurosurgery) and Dr. Franz Josef Gildehaus (Nuclear Medicine & Radiopharmacy), he evaluated the application of a radiolabelled version of the fragment in the context of glioblastoma surgery to reduce the risk of later relapse.
Ascenion, Helmholtz Munich’s long-standing technology transfer partner, has been working with Reinhard Zeidler for years, supporting IP- and transfer related aspects of his work. Ascenion, in close coordination with the Innovation Management Department at Helmholtz Munich, was also instrumental in structuring the licence agreement concluded between Helmholtz Munich and ITM last year for the compound, related patents and know-how for the manufacturing, use and application of LuCaFab. As part of the project team, Ascenion will stay involved and continue to support the translation of this promising approach into clinical practice.
Further information: