Clinical Trial Application (CTA) submitted for Phase I/II trial with TCR immunotherapy MDG1011 in three blood cancer indications

Medigene expects to run one of the first German clinical trials of TCR-modified T cells

Submission triggers final milestone payment for Trianta acquisition

PLANEGG, Germany I July 10, 2017 I Medigene AG (MDG1, Frankfurt, Prime Standard, TecDAX) has filed a clinical trial authorization application (CTA) to begin the Company’s first clinical trial with its proprietary T-cell receptor- (TCR) modified T cells as an immunotherapy to treat a range of blood cancer indications. The CTA was submitted to the German authority Paul-Ehrlich-Institute (PEI) today. As previously announced, Medigene expects to start this trial by year end 2017.

Medigene intends to start a combined Phase I/II safety and feasibility clinical trial of its TCR therapy MDG1011, subject to regulatory approval. MDG1011 targets PRAME and will be evaluated in patients with advanced hematological diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). The final study design will be made available after CTA approval by PEI. To date, no clinical trials utilizing TCR- modified T cells have been conducted in Germany.

The CTA submission triggers a final milestone payment of EUR 2.0 million from Medigene AG to the former contributing shareholders of Medigene Immunotherapies GmbH (formerly: Trianta Immunotherapies GmbH) within the next five months. Medigene intends to settle this payment through the issuance of new shares from authorized capital. The milestone payment was an agreed part of the purchase price for the acquisition of Trianta in January 2014. With this third and final milestone payment, the total purchase price of approximately EUR 10 million will have been entirely settled.

Dr. Kai Pinkernell, SVP and CMO of Medigene AG, noted: “Starting this TCR trial will be a major development for Medigene. We are excited to begin one of the first TCR trials in Germany so far, utilizing a cellular immunotherapy approach that could one day make a significant difference for cancer patients. In addition to our ongoing clinical trial with DC vaccines, this TCR study will move Medigene’s second immunotherapy technology into clinical stage.”

Prof. Dolores J. Schendel, CEO/CSO of Medigene AG, said: “Through several decades of research, it has been my and my group’s driving focus to develop treatments for patients with advanced hematological diseases. I would like to thank our fine team of scientists for their dedication in helping to fulfill this vision. We are proud of reaching the final milestone in connection with the Trianta acquisition which marks the completion of a successful corporate repositioning, transforming Medigene into a T-cell immunology company with our ‘living immunotherapies’ in clinical development.”

About Medigene’s TCR technology: 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.

The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors (TCRs). 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 first TCR immunotherapy “MDG1011” will be tested in a clinical Phase I/II trial intended to be started by the end of 2017.

Besides the planned company-sponsored TCR trial, Medigene is involved in the preparation of an investigator-initiated trial (IIT) with TCRs in multiple myeloma (MM) to be conducted by the Charité – Universitätsmedizin Berlin in cooperation with the Max Delbrück Centre (MDC), Berlin.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in preclinical and clinical development.

SOURCE: Medigene