Transgene S.A. (Paris:TNG) announces that its Phase IIb/III trial
testing TG4010 in patients with advanced Non-Small Cell Lung Cancer
("NSCLC") expressing MUC11 has recently started receiving
approvals from regulatory agencies and ethical committees in Europe (UK
and France notably) and is expecting more in the coming weeks.
The Phase IIb part of the trial will recruit around 200 patients in 70
clinical centers, in 11 countries. TG4010 will be administered as an
adjunct to chemotherapy, as a first line of treatment, to patients who
have not previously received a chemotherapy treatment. Its primary
objective will be to measure progression-free survival ("PFS").
Recruitment of patients should start in December 2011 and will enroll
both patients with normal and high levels of activated NK cells at
Overall survival will also be observed as a secondary endpoint in the
Phase IIb and will be the primary endpoint of the Phase III part of the
study, which is set to start in 2013 and to recruit around 800 patients
in more than 200 clinical sites.
Depending on the Phase IIb data, the Phase III part of the trial should
recruit only patients with normal levels of activated NK cells, the
population for which a meaningful clinical benefit in terms of overall
survival was observed in the study detailed in an article published
online on October 22, 2011, in The Lancet Oncology journal (the
article was also referenced in The Lancet the same day). The
publication presents the key clinical findings of Transgene's previous
Phase II data with TG4010 in NSCLC. These data had previously been
reported at the annual meeting of the American Association of Cancer
Research as well as at the annual meeting of the American Society of
Clinical Oncology in 2009.
Novartis has an exclusive option to in-license TG4010 based on Phase IIb
"We are very pleased to have the previous Phase II data published in
such a prestigious journal as The Lancet Oncology, as it further
demonstrates the medical relevance of our very innovative approach" said
Philippe Archinard, Chairman and CEO of Transgene. He added: "We
are now all set to start the most ambitious clinical trial Transgene has
ever begun, with the parallel development of a therapeutic vaccine and
two companion diagnostics in a landmark, seamless Phase IIb/III trial."
Selection of MUC1-positive patients with a companion diagnostic
test in development
Measure of activated NK cells by another companion diagnostic test
About TG4010 cancer vaccine:
TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a
poxvirus that combines distinguishing advantages for an optimized
MVA is a highly attenuated strain which has been tested extensively in
humans as a smallpox vaccine and is known to strongly stimulate innate
and adaptive immune responses to antigens.
MUC1 is a major tumor-associated antigen that provides a viable target
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 the study published in The Lancet
The efficacy and safety of TG4010 have been assessed in a randomized,
controlled Phase II study evaluating the therapeutic vaccine TG4010 as
an adjunct to standard chemotherapy in 148 patients with advanced NSCLC.
The primary objective of the study was met (Progression free survival at
6 months of at least 40% in the experimental arm).
During the phase II trial, Transgene retrospectively identified a
subpopulation of patients who benefited from the treatment with TG4010
and chemotherapy, versus chemotherapy alone. This sub-population
consisted of patients with normal levels of activated NK cells (natural
killer cells) at baseline and represented some 73 per cent of the
evaluable patient population (101 out of 138 patients). The phase II
clinical results have demonstrated an improved clinical outcome for
patients in this subpopulation with a statistically significant 6 month
increase in median survival (17.1 months in the experimental arm versus
11.3 months in the control arm).
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 II clinical
development: TG4010 and JX594/TG6006 having already completed initial
Phase II 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 forward-looking statements referring to
the clinical testing and development of Transgene's product candidates.
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 favorable 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 Référence on file with
the French Autorité des marchés financiers on its website at http://www.amf-france.org
and Transgene's website at www.transgene.fr
Philippe Archinard, +33 (0)3 88 27 91 22
Boissel,+33 (0)3 88 27 91 02
Executive Vice President & CFO
Castelli, +33 (0)1 44 08 55 05
Raimund Gabriel, +49 89 210 228 30
Brown, +44 207 148 5998