Du är här

2016-02-16

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

Medigene AG / Medigene secures additional viral vector production capacities
for its clinicalTCR studies . Processed and transmitted by NASDAQ OMX
Corporate Solutions.The issuer is solely responsible for the content of this
announcement.
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 anex-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 visitwww.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 ofin 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.

Contact Medigene

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

In case you no longer wish to receive any information about Medigene, please
inform us by e-mail (investor@medigene.com). We will then delete your address
from our distribution list.

Press release English PDF
http://hugin.info/132073/R/1986124/728644.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medigene AG via Globenewswire

HUG#1986124

Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.