Project ELEVATE initiates clinical trial for development of novel cancer diagnostics

On February 25, 2022 Elthera AG, iCellate Medical AB, Targos Molecular Pathology GmbH and Prof. Dr. Susanne Sebens at the Institute of Experimental Cancer Research (IET) at the University of Kiel are proud reported that the clinical trial for their joint project ELEVATE, funded by the EUREKA Eurstars programme, has commenced (Press release, Elthera, FEB 25, 2022, View Source;utm_medium=rss&utm_campaign=1400-2 [SID1234609049]).

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We are excited to enroll the first subject into the ELEVATE clinical trial. Over the next two years, this trial aims to enroll approximately 200 subjects with colorectal or pancreatic cancer, as well as 50 healthy controls. Tumor and liquid biopsy samples will be collected at the Institute of Experimental Cancer Research at the University of Kiel and will be analysed by the project partners iCellate, Elthera, IET, and Targos. Samples will be analysed for the presence of the cancer-associated target protein L1CAM on tumors, circulating tumor cells and in plasma, with the aim of establishing an integrated diagnostic armamentarium to support patient selection and treatment monitoring for the anti-L1CAM immunotherapy developed by Elthera.

Since the project’s inception in late 2020, Elthera AG (Schlieren, Switzerland) has nominated the clinical candidate molecule for its anti-L1CAM therapy and has initiated pilot preclinical safety studies. iCellate Medical AB (Solna, Sweden) has developed a liquid biopsy-based analysis to identify patients with L1CAM+ circulating tumor cells (CTCs), and Targos Molecular Pathology GmbH (Kassel, Germany) has developed a solid tumor-based immunohistochemistry method to identify patients with L1CAM+ tumors. Prof. Dr. Susanne Sebens’ group at the IET (Kiel, Germany) has prepared for patient recruitment. IET will further evaluate the potential of the anti-L1CAM therapy to be combined with established chemo- and immunotherapies.

"I can’t describe how exiciting this is. To start this very important trial that we now have prepared for over a year is a significant milestone in this project and for iCellate’s circulating tumor cell (CTC) platform, CellMate" says Åsa Rosenquist, VP R&D at iCellate Medical.

Gunther Spohn, CSO of Elthera, comments: "This study will be instrumental in developing a powerful diagnostic toolbox for the clinical testing of our innovative anti-L1CAM immunotherapy. The integration of both solid and liquid tumor biomarkers will provide invaluable information for both patient selection and treatment monitoring in our upcoming clinical phase I/II studies."