Medigene AG, a biotechnology company headquartered in Martinsried near Munich, Germany, announced that the German Senior Federal Authority “Paul-Ehrlich-Institute” (PEI) and the relevant ethics committee have approved the study design of the first planned Phase I/II clinical trial with its T cell receptor (TCR)-modified T cell therapy MDG1011.
Additionally, Medigene’s contract manufacturer has received the required product-specific manufacturing license to produce the study material from the local competent authority. PEI is currently reviewing the locally granted manufacturing license and Medigene expects to start the trial within the coming weeks.
MDG1011 is Medigene’s first proprietary, clinical stage TCR immunotherapy product candidate. The TCR-modified T cell product targeting the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma) will be tested in a Phase I/II clinical trial in approximately 92 blood cancer patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM).
The clinical trial will be performed by the Department of Internal Medicine III of the University Hospital Regensburg (Director: Prof. Dr. Wolfgang Herr) under the leadership of the coordinating investigator PD Dr. Simone Thomas, as well as by the University Hospitals of Erlangen and Würzburg, Germany.
The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex vivo).
Medigene AG is developing highly innovative immunotherapies to target various forms and stages of cancer. Company concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.