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Transgene Presents Promising Pre-Clinical Data on TG1050
to Treat Chronic HBV at EASL 2013
– Initiation of a Phase I study in 2014
– New first in class immunotherapeutic to treat CHB
Strasbourg, April 29th, 2013 - Transgene SA (Euronext Paris: FR0005175080), a biopharmaceutical
company that develops targeted immunotherapy products to treat major unmet medical needs in
cancer and chronic infectious diseases, announced pre-clinical data obtained with its novel
immunotherapeutic, TG1050, to treat chronic hepatitis B infection (CHB). These results were
presented in an oral session (Hepatitis B and D Experimental) at this year’s European Association for
the Study of the Liver Conference (Amsterdam, Netherlands, April 24-28, 2013).
Philippe Archinard, Chairman and Chief Executive Officer of Transgene, stated: “We are excited that
TG1050 was selected for an oral presentation at EASL. We hope that this presentation will trigger
interest in the scientific community as well as discussions with potential partners. We expect to start
a first-in-human/phase 1 clinical trial in 2014 and we believe that TG1050 is currently the most
promising direct active immunotherapeutic in development for the treatment of CHB, an area of
unmet medical need and high worldwide prevalence.”
The selection process from 32 promising product candidates of TG1050 was endorsed and approved
by different panels of key opinion leaders in the viral hepatitis field. TG1050 is based on a nonreplicative Adenovirus 5 vector that encodes three HBV (Hepatitis B Virus) antigens or related
domains. The clinical candidate has demonstrated potent immunogenicity in pre-clinical mouse
models as well as genetic stability. Immunogenic properties include induction of potent, multispecific, functional and cross-reactive T cell responses, including both cytokines production
(IFN/TNF) and in vivo cytolysis; all important characteristics that have been associated with viral
clearance during natural infection.
Today’s presentation provided updated and more recent data that demonstrated the capacity of
TG1050 to induce long-lasting HBV-specific memory T cells. Experiments in two murine models based
on hepatic expression of the full length HBV genome, a HBV transgenic mouse model (University of
Ulm) and a model using a recombinant adenovirus associated virus encoding HBV (AAV-HBV,
Institute Pasteur) showed that a single injection of TG1050 had the capacity to educate HBV-specific
functional T cells within a tolerant environment without inducing liver inflammation, whilst
displaying antiviral activities, which were particularly shown in the AAV model.
“TG1050 is to my knowledge the most comprehensive HBV immunotherapeutic currently under
development that will be delivered by a single vector. Viral vectors and adenovirus-based vectors in
particular, remain today the most efficient delivery platform when it comes to inducing strong cellular
immune responses which play a central role in the control of HBV infection. A strong inverse
correlation exists between HBV specific functional T-cells and control/eradication of viremia;
immunotherapeutic for the treatment of CHB may provide a significant increased cure rate to the
existing antiviral drugs” stated Dr Fabien Zoulim, Medical Director of the Liver Department at the
Hospices Civils de Lyon and Scientific Director of the Hepatitis Research Laboratory at INSERM Unit
1052. He added further: “This type of approach provides new hope towards the development of a
treatment with limited duration either alone or in combination with nucleoside alogues.”
About TG1050
The novel immunotherapeutic product TG1050 developed by Transgene to treat chronic infection by
hepatitis B is based on a recombinant non-replicative human adenovirus serotype 5, expressing
multiple specific HBV antigens (Core, Polymerase and Envelope) from genotype D. The product has
been designed to prime de novo and/or stimulate functional T cells expected to control the HBV
replication and to elicit viral clearance.
According to the World Health Organization’s (“WHO”) estimates, 350 million people are chronic
carriers (WHO, 2009) of HBV. Hepatitis B is more common in some parts of the world than others. In
China and other parts of Asia, up to 10% of the population is believed to be chronically infected. In
addition to the significant burden of disease, CHB is responsible for 1 million deaths each year due to
related complications such as liver failure, cirrhosis or hepatocellular carcinoma (liver cancer).
About Transgene
Transgene (NYSE-Euronext: TNG), a member of the Institut Mérieux Group, is a biopharmaceutical
company. We create, develop and manufacture targeted immunotherapeutics for the treatment of
cancers and infectious diseases. Our products are major technological breakthroughs that use well
tolerated viruses to indirectly or directly kill infected or cancerous cells. Our four most advanced
products have generated proof of concept data in randomized clinical studies: in lung cancer
(TG4010), liver cancer (Pexa-Vec), hepatitis C (TG4040) and HPV-related cervical lesions (TG4001).
We have concluded strategic agreements for the development of three of these products: an option
agreement with Novartis for the development of TG4010, an in-licensing agreement with US-based
Jennerex, Inc. to develop and market Pexa-Vec and a strategic collaboration with EORTC to develop
TG4001 in cancer of the oropharynx. We also have a non-exclusive agreement with Sanofi/Genzyme
for the future commercial production of our products. Most of our 280 employees are based in
Strasbourg, France, and we have operations in Lyon, China and the USA. Additional information
about Transgene is available at http://www.transgene.fr.
Transgene Forward Looking Statements
This press release contains forward-looking statements notably referring to the future development
of TG1050 as a treatment against chronic hepatitis B. Such anticipated development is based on the
results obtained in preclinical models. These results are not necessarily predictive of the results that
we may obtain in future clinical testing on Man. We could never be able to develop, manufacture or
sell TG1050 in the future. For further information on the risks and uncertainties involved in the
testing and development of Transgene’s product candidates, see Transgene’s Document de
Référence on file with the French Autorité des marchés financiers on its website at http://www.amffrance.org and on Transgene’s website at http://www.transgene.fr.
ontacts:
Transgene
Philippe Archinard, Chairman & CEO, +33 (0)3 88 27 91 22
Stéphane Boissel, Executive Vice President & CFO, +33 (0)3 88 27 91 02
Elisabetta Castelli, Director IR, +33 (0)3 88 27 91 21
MC Services
Raimund Gabriel, +49 89 210 228 30
Shaun Brown, +44 207 148 5998
Трансгена Перспективная доклинических Данных по TG1050
для Лечения Хронического гепатита в 2013 EASL
- Начало Фазы исследования в 2014 году
- Новое в первый класс иммунотерапии для лечения ХГВ
как я поняла на геп В и D нацелен...
. Данный пост размещен был ни собакам на драку,а для прочтения и информации, Юрик сам сказал,даже не интересовался,видимо так просто написал " скептик" .
