[October 23, 2017] |
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TG1050 is Well Tolerated and Induces a Strong Specific Immune Response in Patients with Chronic Hepatitis B
Regulatory News:
Transgene (Paris:TNG), a biotech company that designs and develops
viral-based immunotherapies, announces that the analyses conducted on
patients with chronic hepatitis B receiving standard antiviral therapies
and a single dose of TG1050 in the Phase 1/1b trial, confirm the good
tolerability profile and demonstrate the immunogenicity of this novel
therapeutic vaccine.
Transgene presented a poster describing the first promising clinical
data of TG1050 on October 21, 2017, at the annual meeting of the AASLD (American
Association for the Study of Liver Diseases) that is currently
taking place in Washington, DC. These results were obtained from
the first cohort of patients included in the Phase 1/1b trial;
patients that are currently treated with standard antiviral therapy also
received a single dose of TG1050. The data presented further
strengthen the first elements communicated in 20161, i.e.
a very satisfying tolerability profile of TG1050. They also confirm
the product's mechanism of action.
The immunologic analyses show that TG1050 induces a specific immune
response in the patients:
-
Strong immune responses against the different HBV antigens that are
vectorized by TG1050 (core protein, polymerase and envelop protein
- HbsAg) have been shown in the patients who received the two highest
doses (1010 vp et 1011 vp);
-
A dose-effect relationship was observed in terms of number of
patients developing responses against the different viral antigens,
with a higher intensity of responses in the groups receiving the two
highest doses (1010 vp et 1011 vp).
The abstract published in Hepatology can be downloaded on the AASLD
website. The poster is accessible from Transgene's website: www.transgene.fr.
Prof Fabien Zoulim, MD, PhD, principal investigator of the trial and
head the gastro-enterology service of the Croix-Rousse Hospital (Lyon,
France), commented: "Patients with chronic hepatitis B are currently
treated over very long periods. They live with the risk of developing
severe complications due to the disease and are expecting therapies that
can cure them. The results obtained after a single injection of TG1050
are very promising and confirm the expected mechanism of action of this
novel therapeutic vaccine. We are looking forward to presenting the full
results of the trial at upcoming major international conferences
dedicated to liver diseases."
-End-
Notes to editors
About TG1050 TG1050 is a targeted immunotherapy
candidate for the treatment of chronic hepatitis B, ased on a viral
vector expressing three HBV antigens. It is a therapeutic vaccine that
has been designed and developed by Transgene's antiviral research team.
Preclinical results have demonstrated TG1050's capacity to induce
robust, broad, and long-lasting HBV-specific T cells with
characteristics similar to those found in patients whose infection has
been resolved. Antiviral effects of TG1050have also been shown2 3.
TG1050 is currently being evaluated in an international first-in-man
Phase 1/1b trial in patients who are being treated for chronic HBV
infection with standard-of-care antiviral therapies. This trial is
randomized, multi-center, double-blind, and placebo-controlled. The
primary objectives of the Phase 1/1b study are to evaluate the safety
and tolerability of TG1050 administered in single and multiple doses and
to determine the dose and schedule of TG1050 administration for further
development. Secondary objectives correspond to the exploration of
antiviral activity and immune responses to TG1050.
The technology of TG1050 is also being developed in China through
Transgene's joint-venture with Tasly Biopharmaceutical Technology, where
it is currently under SFDA evaluation and has been recently granted an
IND number. The latest publications on TG1050 are available on: www.transgene.fr.
About Chronic Hepatitis B Hepatitis B is a
potentially life-threatening liver disease caused by HBV infection. It
puts patients at high risk of death from cirrhosis and liver cancer.
Recent figures indicate the number of patients being treated for chronic
hepatitis B was 200,000 in total in the United States, Germany, France,
Italy, Spain and the United Kingdom and 100,000 patients in Japan. The
eligible Chinese market represents 500,000 patients. Those numbers are
expected to increase (Sources: ECDC- Incidence of Hepatitis B, Decision
Resources: expert opinions). Currently available antiviral treatments
can control the disease but not cure it. Patients in the developed world
must take these treatments for an average of 15 years and often for
their lifetime. Therefore, there is an urgent need to develop new
therapeutic approaches to improve the cure rate.
About Transgene Transgene S.A. (Euronext: TNG), part
of Institut Mérieux, is a publicly traded French biotechnology company
focused on designing and developing targeted immunotherapies for the
treatment of cancer and infectious diseases. Transgene's programs
utilize viral vector technology with the goal of indirectly or directly
killing infected or cancerous cells. The Company's lead clinical-stage
programs are: TG4010, a therapeutic vaccine against non-small cell lung
cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a
therapeutic vaccine against HPV-positive head and neck cancers. The
Company has several other programs in clinical development, including
TG1050 (chronic hepatitis B) and TG6002 (solid tumors). Transgene is
based in Strasbourg, France, and has additional operations in Lyon, as
well as a joint venture in China. Additional information about Transgene
is available at www.transgene.fr.
Follow us on Twitter (News - Alert): @TransgeneSA
Disclaimer This press release contains
forward-looking statements, which are subject to numerous risks and
uncertainties, which could cause actual results to differ materially
from those anticipated. The occurrence of any of these risks could have
a significant negative outcome for the Company's activities,
perspectives, financial situation, results, regulatory authorities'
agreement with development phases, and development. The Company's
ability to commercialize its products depends on but is not limited to
the following factors: positive pre-clinical data may not be predictive
of human clinical results, the success of clinical studies, the ability
to obtain financing and/or partnerships for product manufacturing,
development and commercialization, and marketing approval by government
regulatory authorities. 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 Référence, available on the AMF
website (http://www.amf-france.org)
or on Transgene's website (www.transgene.fr).
Forward-looking statements speak only as of the date on which they are
made and Transgene undertakes no obligation to update these
forward-looking statements, even if new information becomes available in
the future.
1 Press release distributed on July 21, 2016 2
Gut. 2015 Dec;64(12):1961-71. doi: 10.1136/gutjnl-2014-308041 3
J Hepatol, 2015, Vol 62 (Suppl N° 2), S205
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