Transgene to Collaborate with the EORTC on a Phase 2b Trial with TG4001 in Head and Neck Cancer
13 November 2012 - 5:45PM
Business Wire
Regulatory News :
Transgene SA (Euronext Paris: FR0005175080) (Paris:TNG) today
announced that it will collaborate with the European Organization
for Research and Treatment of Cancer (“EORTC”) for the conduct of a
randomized phase 2b study of TG4001 in patients with HPV16 positive
Oropharyngeal Squamous Cell Carcinomas (OSCCs).
The study will be a multinational, placebo controlled,
randomized, phase 2b trial led by the EORTC in which TG4001 will be
administered in combination with chemo-radiotherapy in patients
with HPV16 positive OSCCs whose tumor is locally advanced
(non-metastatic). The main objective of the study will be to show a
reduction in the relapse rate in patients receiving TG4001 in
addition to this standard of care. Approximately 200 patients
should be enrolled.
“The EORTC welcomes this new partnership with Transgene aiming
at improving outcomes for the HPV16-positive subset of patients”
said EORTC Director Dr. Denis Lacombe. He added: “Currently the
standard treatment is chemo-radiotherapy and we believe combining
it with TG4001, an HPV-targeted immunotherapy, could potentially
improve the survival rate of patients.”
The trial is scheduled to start in late 2013 and should deliver
its first safety and efficacy results in 2016. Under certain
conditions, to be further discussed between Transgene and EORTC,
this clinical trial could be extended to a phase 3 that could serve
as a registrational study for TG4001 in this indication.
Since 2011, Transgene has regained full rights to TG4001 from
Roche. Clinical results (released in 2012) from a phase 2b trial
conducted by Roche in 206 high grade cervical dysplasia (CIN2/3)
patients demonstrated a significant level of activity of the
therapeutic vaccine compared to placebo.
"We are very pleased to announce this collaboration with the
EORTC, a leading independent European cancer research organisation
which is at the forefront of the development new cancer treatment
strategies” said Philippe Archinard, President and CEO of
Transgene. He added: “This is an opportunity to improve the cure
rate for patients and also a good opportunity for Transgene to
explore and extract value from this asset, for which interesting
proof of concept data were previously obtained in a monotherapy
trial. The combination of therapeutic vaccine and chemotherapy is
based on a strong clinical rationale as evidenced by Transgene in a
previous trial combining TG4010, an MVA-MUC1 vaccine, to
chemotherapy in non-small cell lung cancer".
About the Targeted
Market:
The market for head and neck cancers was valued by Transgene at
$1 billion in annual sales in 2010. It is currently growing fast
and is expected to reach close to $2 billion in value by 2017. This
growth is primarily attributed to the increasing prevalence and
diagnosis rate of the disease but also to the introduction of new
effective therapies as unmet medical needs are significant.
Transgene estimates the eligible population (incidence) for the
combination of TG4001 and radio-chemotherapy in the HPV16-related
head and neck squamous cell carcinomas (“HNSCC”) to be between
10,000 and 15,000 patients. As the only HPV-targeted therapy in
advanced clinical development in HNSCC, the combination could
expect a penetration superior to 50% of the eligible
population.
About Transgene:
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
2 clinical developments: TG4010 and JX594/TG6006 having already
completed initial phase 2 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.
About the EORTC:
The EORTC is a unique organization – a vibrant example of the
fact that academic science and research know no national
boundaries. Established in 1962, the EORTC is a non-profit European
research organization operating as an international association
under Belgian law. The EORTC currently links a network of more than
2,500 pre-clinical scientists and oncologists in more than 300
hospitals in over 30 countries. It encompasses all aspects of
cancer research, from translational research and new drug
development to large phase III clinical trials and meta-analyses.
The 170 members of the EORTC Headquarters staff handle some 6,000
new patients enrolled each year in cancer clinical trials,
approximately 30 protocols that are permanently open to patient
entry, over 50,000 patients who are in follow-up, and a database of
more than 180,000 patients. The ultimate goal of the EORTC is to
improve the future of cancer therapy by developing new agents and
innovative approaches and to test more effective treatment
strategies using commercially available drugs, or surgery and
radiotherapy.www.eortc.org
Disclaimer:
This press release contains certain forward-looking statements.
Although the company believes its expectations are based on
reasonable assumptions, these forward-looking statements are
subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated. In
particular, the Company’s ability to commercialize its first
product depends on the continuing success of clinical studies,
ongoing financing for further product developments and marketing
launch, a positive response from the medical community regarding
the product’s costs and effectiveness. 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
Reference prospectus, which is available on the AMF website
(http://www.amf-france.org) or on Transgene’s website
(www.transgene.fr). This press release and the information
contained herein do not constitute an offer to sell or a
solicitation of an offer to buy or subscribe to shares in Transgene
in any country.
Société anonyme au capital de 72.523.405 € –
R.C. Strasbourg B 317 540 581400 boulevard Gonthier d’Andernach –
Parc d’Innovation - CS80166 – 67405 ILLKIRCH GRAFFENSTADEN CEDEX
(France)Tél : + 33 (0)3 88 27 91 00
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