Transgene to Present Positive Results from Phase 1b Trial of TG1050 in Patients with Chronic Hepatitis B at Upcoming AASLD Liver Meeting 2018

  • Prof Fabien Zoulim will report that the Phase 1b trial reached its
    safety primary endpoint and that the therapeutic vaccine TG1050 breaks
    immune tolerance in patients with chronic hepatis B virus (HBV)
  • Transgene will also present new and promising preclinical data set
    on combination studies of TG1050 with antivirals and immunomodulators

STRASBOURG, France–(BUSINESS WIRE)–#HBV–Regulatory News:

Transgene (Paris:TNG), a biotech company that designs and
develops virus-based immunotherapies, announces that the detailed
results of the Phase 1b clinical trial using TG1050 confirm that the
safety primary endpoint was reached and that TG1050 breaks immune
tolerance through improvement of immune response directed against HBV
antigens in patients with chronic HBV receiving standard antiviral
. The complete Phase 1b data will be presented by Prof
Fabien Zoulim, MD, PhD, on November 9, 2018, at the annual meeting of
the AASLD (American Association for the Study of Liver Diseases)
in San Francisco (USA).

Transgene will also present new and promising preclinical data that
showed an improved antiviral activity of TG1050 (including on the
decrease of circulating HBV surface antigen – HBsAg) when administered
in combination with direct acting antivirals or immunomodulators in
HBV-persistent mice.

Safety and Immunogenicity of Single and Multiple Injections of the
Therapeutic Vaccine TG1050 in NUC-Suppressed Chronic Hepatitis B (CHB)
Patients: Unblinded Analysis of a Double-Blind, Placebo-Controlled Phase
1b Study

  • Presenter: Prof Fabien Zoulim, principal investigator of the trial and
    head of the gastro-enterology service of the Croix-Rousse Hospital
    (Lyon, France)
  • Abstract number: 426
  • Session date, time and location: Session I, November 9, 2018, 12
    pm-1.30 pm (PT), Hall C

Investigational treatment combining TG1050, an HBV-specific
immunotherapeutic, with direct acting antivirals or immunomodulators,
improves sustained antiviral effects and immune responses in
HBV-persistent mice

  • Presenter: Roland Kratzer, Transgene
  • Abstract number: 438
  • Session date, time and location: Session I, November 9, 2018, 12
    pm-1.30 pm (PT), Hall C

Both abstracts published in Hepatology can be downloaded from the AASLD


About TG1050
TG1050 is a targeted immunotherapy
candidate for the treatment of chronic hepatitis B, based on a viral
vector expressing three HBV antigens (POL, CORE, ENV). The first-in-man
Phase 1/1b trial met its primary safety endpoint and also showed that
TG1050 is able to break immune tolerance in patients chronically
infected with HBV.
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 TG1050 have also been shown1

The technology of TG1050 is also being developed in
Greater China by Tasly Biopharmaceuticals Co., Ltd.

About the Phase 1b trial evaluating TG1050
international first-in-man Phase 1/1b trial of TG1050 has recruited
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 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.
48 patients were enrolled (Europe and
North America), randomized 1:1:1 across 3 dose levels of 109,
1010, 1011 viral particles (vp) and then 3:1
within each dose level to placebo. 12 patients were enrolled in the
single dose cohort and received a single subcutaneous (sc) injection
while 36 patients enrolled in the multiple dose cohort received 3 weekly
sc injections. At inclusion, patients had to be HBV DNA negative after
at least 2 years of NUC therapy.

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
throughout their lifetime. Therefore, there is an urgent need to develop
new therapeutic approaches to improve the cure rate.
The latest
publications on TG1050 are available on: www.transgene.fr.

About Transgene
Transgene (Euronext: TNG) 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 (a therapeutic
vaccine for the treatment of chronic hepatitis B) and TG6002 (an
oncolytic virus for the treatment of solid tumors).
With its
proprietary Invir.IOTM, Transgene builds on its expertise in
viral vectors engineering to design a new generation of multifunctional
oncolytic viruses.
MyvacTM, an individualized
MVA-based immunotherapy integrating neoantigens, completes this
innovative research portfolio.
Additional information about
Transgene is available at www.transgene.fr.Follow
us on Twitter: @TransgeneSA

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 (
or on Transgene’s website (
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 Gut. 2015 ; TG1050, an immunotherapeutic to treat
chronic hepatitis B, induces robust T cells and exerts an antiviral
effect in HBV-persistent mice.Martin P et al., 2015 Dec, 64(12):1961-71.
doi: 10.1136/gutjnl-2014-308041

2 Hum Vaccin
Immunother. 2018;
A meta-analysis of the antiviral activity of the
HBV-specific immunotherapeutic TG1050 confirms its value over a wide
range of HBsAg levels in a persistent HBV pre-clinical model, Kratzer R.
et al., 2018 Jun 3;14(6):1417-1422.


Lucie Larguier
Director Corporate
Communications & IR
+33 (0)3 88 27 91 04

Citigate Dewe Rogerson
David Dible/Marine
+ 44 (0)20 7638 9571


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