Medigene AG: Medigene announces clinical trial agreement for HA-1 TCR immunotherapy MDG1021 with University of Leiden

Martinsried/Munich (pta005/22.05.2019/07:30 UTC+2) -
- MDG1021 selected as Medigene's next proprietary clinical TCR-T candidate
- Preparations ongoing for a Phase I clinical trial in relapse after allogeneic hematopoietic stem cell transplantation
- Clinical trial start scheduled for 2020

Medigene AG (FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, announced today that it entered into a Clinical Trial Agreement with the Leiden University Medical Center (LUMC), the Netherlands, to conduct a Phase I clinical trial with Medigene's T cell receptor (TCR) modified T cell therapy MDG1021 targeting the HA-1 antigen. The study is scheduled to start in 2020 as Medigene's second company-sponsored clinical TCR-T trial.

Medigene plans to assess the safety, feasibility and preliminary efficacy of MDG1021 in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation, an area with high unmet medical need. HA-1, expressed on normal cells of the patient's hematopoietic system as well as on lymphoma or leukemic cells, can be targeted by MDG1021 with the goal to eradicate the disease and allow the donor stem cells to repopulate the blood forming system.

Dr. Kai Pinkernell, Chief Medical Officer and Chief Development Officer at Medigene, comments: "We are excited to announce MDG1021 as Medigene's next clinical TCR therapy candidate. In collaboration with the team at LUMC we are looking forward to expand the existing clinical experience with this T cell receptor. We will now develop a clinical trial design, set up a GMP-compliant manufacturing process and prepare a clinical trial application to move this interesting immuno-therapeutic candidate into clinical development as fast as possible."

Mirjam Heemskerk, Associate professor at the Department of Hematology, LUMC, comments: "We are excited to collaborate with Medigene and start a new clinical trial in which patients with relapsed or persistent hematologic malignancies will be treated with the HA-1 TCR immunotherapy MDG1021."

Medigene in-licensed the HA-1 TCR from the Leiden University Medical Center at the end of 2018 to broaden and accelerate the development of its proprietary TCR pipeline. The TCR specific for the minor histocompatibility antigen HA-1 was developed by LUMC and tested for preliminary safety and tolerability in a Phase I clinical trial involving five patients. LUMC will conduct the planned clinical trial on behalf of Medigene.

About HA-1: HA-1 is a well-characterized minor histocompatibility antigen, based on the variable expression of the HMHA1 gene. It is present in all cells of the hematopoietic system, but not on other normal cells. It is also present in leukemia, lymphoma cells, as well as in various solid tumors. The immunogenic variant of HA-1 is present in approximately 50% of individuals and, in the setting of allogeneic hematopoietic transplant and an HLA-A*02:01 background, has been associated with positive clinical benefit through a 'graft versus leukemia' mechanism, without causing severe side effects.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) 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 the focus on T cell-receptor modified T cells (TCR-Ts) and has associated projects currently in pre-clinical and clinical development.

For more information, please visit http://medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

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Tel.: +49 - 89 - 20 00 33 - 33 01,
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