Medigene secures additional viral vector production capacities for its clinical TCR studies

Martinsried/Munich, 16 February 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 for the production and delivery of viral vectors. EUFETS is an experienced contract manufacturing organisation (CMO) that will take over further process development tasks and vector optimisation processes, the establishment of different cell banks, and the batch production of viral vectors for Medigene's T-cell receptor (TCR) based cancer therapies.

These viral vectors ("gene ferries") are required for Medigene's upcoming clinical TCR studies. Viral vectors are non-infectious virus particles that are used for an ex-vivo (outside the body) transfer of T-cell receptor DNA into the patient's own T cells, equipping these cells with the tumour-specific T-cell receptors selected by Medigene. The modified T cells are then reintroduced into the patient's body, where they are intended to identify and destroy the cancer cells.

Within the framework of this staggered agreement, EUFETS will also be responsible for the creation of different master cell banks that can produce vectors coding for further TCRs from Medigene's TCR library. The agreement therefore also ensures the viral vector supply for various future clinical studies.

Prof. Dolores Schendel, CEO and CSO of Medigene , comments on the agreement: "Already last year, when the consortium for the 2016 planned investigator initiated trial on TCRs arranged the viral vector production, we realised that the world's increased research activities in the field of immunotherapies also involves a growing demand for viral vector production capacities. There are not so many companies worldwide able to provide viral vectors in the quantity and quality required for clinical trials. Hence we are particularly pleased that we won EUFETS as a competent local partner for Medigene, able to assure production capacities for any of our planned TCR studies."

Dr. Klaus Kühlcke, Managing Director of EUFETS GmbH, adds: "At EUFETS we have years of experience in the development and optimisation of high-performance cell cultures and the design and manufacturing of state of the art retroviral vectors. I am particularly happy being able to support Medigene in preparing the planned T-cell receptor-based studies."

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 tumour loads. The clinical development of Medigene's TCRs is in preparation.

The TCR technology aims at arming the patient's own T cells with tumour-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumour cells. This immunotherapy approach attempts to overcome the patient's tolerance towards cancer cells and tumour-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 tumour 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)-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 tumour-associated antigens will be isolated and characterised. In the years ahead, Medigene plans to develop up to 10 lead candidates for the TCR technology, and to initiate up to three clinical TCR trials, the first to be started in 2016 (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: https://vimeo.com/123007480

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 personalised T-cell-based immunotherapies.

For more information, please visit www.medigene.com

About EUFETS
EUFETS GmbH, a subsidiary of BioNTech AG specialises 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 recognised 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.

Contact Medigene

Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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