Medigene commissions EUFETS for cell production process for first own TCR studies

Martinsried/Munich, 18 May 2016. Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, has signed an agreement with the contract manufacturer EUFETS GmbH, a subsidiary of BioNTech AG, for the production of T-cell receptor-modified T cells. EUFETS will set up the cell production together with Medigene for supplying the company's planned phase I/II TCR studies.

In its own clinical TCR studies, Medigene plans to equip the patient's T cells with specially selected T-cell receptors. This transduction called transfer of genetic information is accomplished by viral vectors of the latest generation that are also produced at EUFETS. As part of this new agreement, the transduction and the subsequent cultivation and multiplication of T cells will be carried out according to GMP1in the clean rooms at EUFETS. The modified T cells are infused back into the patient's body where they should identify and destroy the cancer cells.

Prof. Dolores Schendel, CEO and CSO of Medigene, comments on the agreement: "As with the viral vectors, we want to secure the necessary capacity for our first own TCR studies at an early stage. EUFETS is very experienced in dealing with T cells and is therefore especially suited as a partner. Since the necessary viral vectors are also produced by EUFETS, administration and logistics are additionally simplified."

Dr. Klaus Kühlcke, Managing Director of EUFETS GmbH, adds: "EUFETS will make an important contribution to the implementation of these promising and exciting trials by producing both the vectors and the genetically modified T cells. We are very pleased that this project will further strengthen the good cooperation between EUFETS and Medigene."

About Medigene's TCR technology: Medigene's technology for T-cell receptor-modified T cells is one of the company's highly innovative and complementary immunotherapy platforms for adoptive T-cell therapy. The TCR therapy is designed to treat patients with high tumor loads. The clinical development of Medigene's TCRs is in preparation.

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). A large army of specific T cells to fight the tumor is made available to patients within a short period of time.

In the scope of this platform, Medigene is developing a comprehensive library of recombinant T-cell receptors. Moreover, a good manufacturing practice (GMP[1])-compliant process for their combination with patient-derived T cells is currently being established.

Medigene is preparing the clinical development of its first product candidates. In addition, novel TCRs with specificities for promising tumor-associated antigens will be isolated and characterized. In the years ahead, Medigene plans to initiate up to three clinical TCR trials, the first to be started in 2016/2017 (IIT phase I study with participation of Medigene, subject to grant funding). Medigene-sponsored trials are planned to start in 2017 and in 2018.

Further audio-visual education about Medigene's TCR technology at:

Medigene AG is a publicly listed (Frankfurt: MDG1, prime standard) biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative, complementary treatment platforms to target various types and stages of cancer with candidates in clinical and pre-clinical development. Medigene concentrates on the development of personalized T-cell-based immunotherapies.

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EUFETS GmbH, a subsidiary of BioNTech AG specializes in providing services in the area of development and manufacture of cell-based and gene-based therapeutics. EUFETS possesses comprehensive know-how in the development and production of stem cell preparations, retroviral vectors, and genetic modification of primary cells and cell lines. Since 1999, the company has been GMP-certified, and is meanwhile recognized as a leading producer of retroviral vectors for clinical trials worldwide. Since 2012, EUFETS has also added the GMP manufacturing of in vitro transcribed mRNA to its portfolio.

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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[1] Good Manufacturing Practice (GMP)are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products.