Medigene AG: Announces target and outlines design for its first clinical trial in TCR cancer immunotherapy

Medigene AG (FSE: MDG1, Prime Standard, TecDAX), today announced details on the Company's first clinical trial with T-cell receptor-modified T cells, planned to start in late 2017. Medigene will use an HLA-A2:01-restricted T-cell receptor (TCR) that targets PRAME, a well characterized tumor antigen. Medigene identified a TCR candidate for this target that demonstrates favorable safety and efficacy in extensive preclinical studies. Data on Medigene's selected TCR candidate will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting taking place from April 1-5, in Washington, D.C., USA.

Subject to regulatory approval, Medigene intends to start a combined Phase I/II safety and feasibility trial of its TCR targeting PRAME, named MDG1011, in patients with advanced hematological diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). The Phase I part of this First-in-Man trial is designed as a dose escalation, testing up to 4 dose cohorts in a 3+3 design. The chosen dose will then be further tested in the Phase II part which will include a prospective control group and might potentially be extended into further malignancies. Final details, including trial size, study sites and timelines will become available after clinical trial approval by the competent authority.

Prof. Dolores Schendel, CEO and CSO of Medigene, commented: "Based on extensive preclinical assessment, we are convinced that our TCR specific for the PRAME antigen with high avidity, potent antitumor efficacy and a favorable safety profile will enable us to execute a unique clinical program. This particular trial design examining various indications in parallel allows for faster decisions about future clinical development options based on multiple clinical data sets."

The antigen PRAME (Preferentially Expressed Antigen in Melanoma) was first discovered in melanoma and is overexpressed in a variety of solid cancer indications and several hematological malignancies, while its expression pattern in normal tissue is mainly limited to testis, making it an attractive target for adoptive T cell therapy. As this antigen is expressed intracellularly, it is an ideal candidate for a TCR approach, which otherwise could not be targeted with chimeric antigen receptor (CAR) T cells. Medigene already uses PRAME as a target in its ongoing DC-vaccine trial in AML, where the favorable safety profile of this vaccine allowed the trial to advance into Phase II in April 2016 (Phase I/II final data expected for late 2019).

To view the abstract of the upcoming AACR presentation please visit: http://bit.ly/2nnExnY

About Medigene's TCR technology: 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).

TCR therapy is developed to utilize a higher number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a pipeline of recombinant T-cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells.

Medigene's TCR technology for adoptive T-cell therapy is one of the company's three highly innovative and complementary immunotherapy platforms in immuno-oncology.