Transgene's Therapeutic Vaccine TG4010 Shows Promising Preliminary Phase IIbData in Advanced Non-Small Cell Lung Cancer



    STRASBOURG, France, Jan. 10 /CNW/ - Transgene (Euronext Paris:
FR0005175080) announces promising preliminary data from the Phase IIb trial
evaluating its therapeutic vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to
first line chemotherapy in patients with advanced non-small cell lung cancer
(NSCLC).
    This on-going trial is a randomized, open label and controlled study
designed to assess the efficacy of TG4010 in combination with cisplatin and
gemcitabine compared to the chemotherapy regimen alone. The trial completed
the enrolment of 148 patients at the end of May 2007 and was conducted in 27
centres located in France, Poland, Germany, and Hungary. The patients had
NSCLC expressing MUC1, either stage IIIB with effusion or stage IV, and had
not received prior systemic treatment for their advanced disease. Half of the
patients received the combination regimen (TG 4010 vaccine plus chemotherapy)
and the other half of the patients received chemotherapy alone.
    The trial confirmed the favourable safety profile of TG4010 when
associated to chemotherapy: most adverse events observed so far were
considered related to chemotherapy as well as to the underlying disease.
Hematological toxicity was equivalent in both treatment groups. Most frequent
adverse events related to TG4010 were injection site reactions and asthenia,
which are classical vaccine associated reactions.
    Based on the local evaluations performed at investigation centres,
results so far are showing a positive trend in favour of the combination of
TG4010 with the chemotherapy. These results nevertheless remain subject to a
centralised review process that is presently on-going.
    "We report today encouraging trends on the preliminary results of our
Phase IIb trial with TG4010 in non-small cell lung cancer" said Philippe
Archinard, Chief Executive Officer of Transgene. "We expect to present data
during the second quarter of this year and final data by the fourth quarter of
2008."

    About TG4010 cancer vaccine

    TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a
poxvirus that combines distinguishing advantages for an optimized systemic
vaccination:

    - MVA is a highly attenuated strain which has been tested extensively in
humans as a smallpox vaccine and is known to strongly stimulate the immune
response to antigens.

    - MUC1 is a major tumor-associated antigen that provides a viable target
for vaccination.

    - TG4010 expresses the entire MUC1 gene sequence and has the potential to
generate an immune response to all antigenic epitopes of MUC1.

    - The sequence coding for the cytokine Interleukin 2 (IL2) is included to
help stimulate specific T-cell response.

    About previous TG4010 clinical data

    Non-controlled Phase II data are available at:
http://www.transgene.fr/us/pdf/communique_presse/communiques_divers_2005/PR- U
S_17-05-2005_ASCO_POUMON.pdf (Due to the length of this URL, it may be
necessary to copy and paste this hyperlink into your Internet browser's URL
address field. Remove the space if one exists.)

    About Transgene

    Transgene is a France-based biopharmaceutical company dedicated to the
development of therapeutic vaccines and immunotherapeutic products in oncology
and infectious diseases. The company has one product which has completed Phase
II trials (TG4001/R3484), two compounds in Phase II trials (TG4010 and TG1042)
and one compound in Phase I studies (TG4040). Transgene has concluded a
strategic partnership agreement with Roche for the development of its
TG4001/R3484 therapeutic vaccine to treat HPV-mediated diseases. Transgene has
bio-manufacturing capacities for viral-based vectors and technologies
available for out-licensing. Additional information about Transgene is
available on the Internet at http://www.transgene.fr.

    Cautionary note regarding forward-looking statements

    This press release contains forward-looking statements referring to the
encouraging trends on preliminary results of one of Transgene's therapeutic
vaccine candidates. However, because these results are preliminary, are based
on local evaluations performed at the clinical trial centres and are subject
to an additional centralised review process by evaluation experts, there can
be no certainty that they will be confirmed. This additional centralised
review may lead to a different evaluation of the results, positive or
negative. Clinical testing and successful product development depend on a
variety of factors, including the timing and success of future patient
enrolment and the risk of unanticipated adverse patient reactions. Results
from future studies with more data may show less favourable outcomes than
prior studies, and there is no certainty that product candidates will ever
demonstrate adequate therapeutic efficacy or achieve regulatory approval or
commercial use. For further information on the risks and uncertainties
involved in the testing and development of Transgene's product candidates, see
Trangene's Document de reference on file with the French Autorite des marches
financiers on its website at http://www.amf-france.org and Transgene's website
at http://www.transgene.fr.





For further information:

For further information: Investor contacts: Transgene: Philippe Poncet,
Chief Financial Officer, Phone: +33-3-88-27-91-21; Press contacts: Capital
MS&L, Mary Clark, Anna Mitchell, Phone: +44-20-7307-5330,
anna.mitchell@capitalmsl.com

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