Transgene (Euronext Paris: TNG, FR0005175080) today announced that it
has achieved pre-clinical proof of concept with a new therapeutic
vaccine candidate, TG1050, aiming at treating chronic infection by the
hepatitis B virus ("HBV").
Positive pre-clinical data supports further development of the product.
These data include:
Robust and broad immune (T cell) response in pre-clinical models after
one or more injections;
Potent in vivo cytolysis1 against several epitopes2;
Genetic stability of the vaccine.
Despite the introduction in the past decade of efficacious new drugs
(Nucleoside analogs - "NUCs"- and PEG-IFN?) to treat CHB, these drugs
result only rarely in the resolution of the infection, which is defined
by the disappearance of circulating hepatitis B virus surface antigen
("HBsAg") and a measurable antibody response against this same antigen,
or HBsAg seroconversion3.
In combination with standard of care, TG1050 has the potential to
increase the level of seroconversion in comparison to current
treatments, and thus could provide a new option for the cure of the
The product is expected to enter clinical development in 2014.
"The promising preclinical proof of concept on this new vaccine
candidate, together with the clinical efficacy data obtained with
TG4040, our therapeutic vaccine against hepatitis C, proves again the
excellence of Transgene's research in the field of infectious diseases" said
Philippe Archinard, Chairman and CEO of Transgene. He added: "Although
the management of CHB has significantly improved over the past decade,
the long-term control of the infection is very rarely achieved and
patients have to endure decades-long treatments. We believe that a
combination of TG1050 with the standard of care could potentially help
to cure the infection, providing relief to millions of patients".
Transgene's HBV research program will be presented today in a poster at
the EASL congress (European Association for the Study of Liver),
in Barcelona, Spain. During the same EASL congress (on April 21, 2012),
Pr. Heiner Wedemeyer, MD, of the Department of Gastroenterology,
Hepatology and Endocrinology at Hannover Medical School (Germany), will
give a "late breaker" oral presentation and present follow up data from
the randomized Phase 2b clinical trial with TG4040, a therapeutic
vaccine against chronic hepatitis C infection for which initial proof of
concept data were released at AASLD in November 2011.
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
About Transgene's HBV vaccine:
Transgene's therapeutic CHB vaccine is based on a recombinant
non-replicative human adenovirus serotype 5, expressing multiple
specific HBV antigens (Core, Envelope and Polymerase) from genotype D.
The vaccine has been designed to prime de novo and/or stimulate
functional T-cells expected to control the HBV replication and to elicit
Transgene, a member of the Institut Mérieux Group, is a publicly traded
French biopharmaceutical company dedicated to the development of
therapeutic vaccines and immunotherapeutic products in oncology and
infectious diseases and has four compounds in Phase 2 clinical
development: TG4010 and JX594/TG6006 having already completed initial
Phase 2 trials, TG4001 and TG4040. Transgene has concluded strategic
agreements for the development of two of its immunotherapy products: an
option agreement with Novartis for the development of TG4010 to treat
various cancers and an in-licensing agreement with US-based Jennerex,
Inc. to develop and market JX594/TG6006, an oncolytic virus. Transgene
has bio-manufacturing capacities for viral-based products. Additional
information about Transgene is available at www.transgene.fr.
This press release contains certain forward-looking statements.
Although the company believes its expectations are based on reasonable
assumptions, these forward-looking statements are subject to numerous
risks and uncertainties, which could cause actual results to differ
materially from those anticipated. In particular, the Company's ability
to commercialize its first product depends on the continuing success of
clinical studies, ongoing financing for further product developments and
marketing launch, a positive response from the medical community
regarding the product's costs and effectiveness. For a discussion of
risks and uncertainties which could cause the company's actual results,
financial condition, performance or achievements to differ from those
contained in the forward-looking statements, please refer to the Risk
Factors ("Facteurs de Risque") section of the Document de Reference
prospectus, which is available on the AMF website (http://www.amf-
france.org) or on Transgene's website (www.transgene.com).
This press release and the information contained herein do not
constitute an offer to sell or a solicitation of an offer to buy or
subscribe to shares in Transgene in any country.
1 Cytolysis is the cell death induced by a rupture in the
cell's membrane following the action of cells from the immune system.
2 An epitope, also known as antigenic determinant, is the
part of an antigen that is recognized by the immune system, specifically
by antibodies, B cells, or T cells.
3 Seroconversion is the development of detectable specific
antibodies to microorganisms in the blood serum as a result of infection
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Philippe Archinard, Chairman & CEO
+33 (0)3 88 27 91 22
Stéphane Boissel, Executive Vice
President & CFO
Phone: +33 (0)3 88 27 91 02
Castelli, Director IR
Phone: +33 (0)1 44 08 55 05
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