Medigene commissions EUFETS for cell production process for first own TCR studies
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Medigene AG /
Medigene commissions EUFETS for cell production process for first own TCR
studies
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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 GMP(1)in 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:
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 personalized T-cell-
based immunotherapies.
For more information, please visit www.medigene.com
About EUFETS
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.
Contact Medigene
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor(at)medigene.com
In case you no longer wish to receive any information about Medigene, please
inform us by e-mail (investor(at)medigene.com). We will then delete your address
from our distribution list.
--------------------------------------------------------------------------------
[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.
Press release in English:
http://hugin.info/132073/R/2013218/746167.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Medigene AG via GlobeNewswire
[HUG#2013218]
Unternehmensinformation / Kurzprofil:
Datum: 18.05.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 471848
Anzahl Zeichen: 7107
contact information:
Town:
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Kategorie:
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