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TRANSGENE (ENX:TNG) Release: First Patient Dosed In A Phase 1/2 Trial Of Pexa-Vec + Opdivo For The First-Line Treatment Of Advanced Liver Cancer

7/31/2017 12:25:37 PM

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Transgene (Paris:TNG), a company that designs and develops viral-based
immunotherapies, today announces that the first patient has been treated
in a Phase 1/2 clinical trial evaluating the combination of Pexa-Vec
with Opdivo® (nivolumab) as a first-line treatment of advanced
hepatocellular carcinoma (HCC), which accounts for approximately 75% of
liver cancers. This open-label trial will assess the safety and
tolerability as well as the anti-tumor activity and efficacy of this
immunotherapy combination regimen in up to 36 patients (NCT03071094).

The principal investigator of this multi-center trial is Prof Olivier
Rosmorduc, MD, Head of Hepato-gastroenterology department at La
Pitié-Salpêtrière Hospital in Paris (France).

More information on the trial is available on

Pexa-Vec: an oncolytic immunotherapy that has shown efficacy

Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic
vaccinia virus expressing GM-CSF. In a Phase 2 trial of Pexa-Vec in
first-line HCC, overall survival was improved in a dose dependent
manner. The median overall survival was 14.1 months for the high-dose
group compared to 6.7 months for the low-dose group.

Pexa-Vec is designed to:

  • selectively destroy cancer cells through the direct lysis (breakdown)
    of cancer cells via viral replication,
  • reduce the blood supply to tumors through tumor vascular disruption,
  • stimulate the body's immune response against cancer cells.

Pexa-Vec + Opdivo® (nivolumab): a promising immunotherapy combination

Pexa-Vec's mechanism of action and its safety profile make it an
appropriate candidate for use in combination with immune checkpoint
inhibitors (ICIs) such as nivolumab.

Nivolumab (Opdivo®, Bristol-Myers Squibb) is a monoclonal antibody
targeted against the PD-1 receptor. It is approved in several cancer
indications and is currently being investigated in HCC within a global
Phase 3 trial.

By targeting two distinct steps in the immune response against cancer
cells, the combination of Pexa-Vec and nivolumab has the potential to be
significantly more effective than either product alone. There is a
strong scientific rationale that suggests that Pexa-Vec's anti-cancer
effects could be enhanced by combining it with nivolumab, which
suppresses the cancer cells' ability to escape the body's immune

Commenting on this innovative clinical trial, Prof Olivier Rosmorduc,
MD, head of Hepato-gastroenterology department at La Pitié-Salpêtrière
Hospital in Paris and principal investigator of the trial, added: "Improving
the treatment of HCC needs a therapeutic approach capable of
significantly boosting the immune system. I am confident that combining
immunotherapies with local and systemic effects such as anti-PD1
nivolumab and the oncolytic virus Pexa-Vec is a powerful strategy to
better treat patients with advanced hepatocellular carcinoma."

Maud Brandely, Chief Medical Officer of Transgene, said: "HCC has a
dismal prognosis which has been marginally improved by current
therapeutic options. Preclinical and clinical data generated
respectively with Pexa-Vec and nivolumab suggest that, in combination,
these novel immunotherapies, with their complimentary modes of action,
have the potential to be more active than each single agent alone. This
may translate into better response rate and increased overall survival
in HCC patients."

About Transgene
Transgene (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 two lead
clinical-stage programs are: TG4010, a therapeutic vaccine against
non-small cell lung cancer and Pexa-Vec, an oncolytic virus against
liver cancer. The Company has several other programs in clinical and
preclinical development, including TG4001 (HPV-positive head and neck
cancers), 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
us on Twitter: @TransgeneSA

About Pexa-Vec
Pexa-Vec (JX594/TG6006 - pexastimogene
devacirepvec) is an oncolytic immunotherapy product based on an
oncolytic vaccinia virus armed with a GM-CSF gene that promotes an
anti-tumor immune response. Pexa-Vec is designed to selectively target
and destroy cancer cells through three different mechanisms of action:
selectively destroy cancer cells through the direct lysis (breakdown) of
cancer cells through viral replication, reduce the blood supply to
tumors through vascular disruption, and stimulate the body's immune
response against cancer cells. The lead indication for Pexa-Vec is
hepatocellular carcinoma (HCC, liver cancer); trials in other cancer
types are underway or planned.
Transgene has exclusive rights to
develop and commercialize Pexa-Vec for the treatment of solid tumors in
Europe. Its partner SillaJen, Inc. is focused on developing Pexa-Vec for
the North American market and has also granted exclusive development and
commercial rights to Pexa-Vec in Hong Kong and The People's Republic of
China to Lee's Pharmaceutical.

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.

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