Transgene Announces Presentations Relating to TG4010 and JX594/TG6006

le
0

Transgene Announces Presentations Relating to TG4010 and JX594/TG6006

at Annual Meeting of the American Society of Clinical Oncology (ASCO)

Strasbourg, France, May 17, 2012 - Transgene (Euronext Paris: FR0005175080)today announces that four separate abstracts relating to clinical studies of the therapeutic cancer vaccine TG4010 and the oncolytic virus JX594/TG6006 have been released today by the American Society of Clinical Oncology (ASCO), ahead of its annual meeting that will take place from June 1st through 5th, 2012 in Chicago, Illinois.

The ongoing TIME study, a phase 2b/3 double-blind, placebo-controlled study comparing first-line chemotherapy with or without TG4010 in patients with stage IV non-small cell lung cancer (« NSCLC ») is presented in abstract #TPS7610 and will also be presented in the General Poster Session on June 2nd, 2012 (Poster Board #53D).

The other three abstracts (#TPS4152, #e14566 and #e13044) relate to data of completed and ongoing clinical trials of JX594/TG6006 (jointly developed by Transgene, Jennerex, Inc. and their partners) in lead indication hepatocellular carcinoma (liver cancer) and in colorectal cancer. All the abstracts are available on ASCO website only at the following address: http://chicago2012.asco.org/Home.aspx.

TG4010: A Therapeutic Vaccine Targeting Cancer

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 innate and adaptive immune responses to antigens.

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

·         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.

The efficacy and safety of therapeutic vaccine TG4010 have been assessed in a randomized, controlled phase 2 study evaluating the 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 2 trial, Transgene retrospectively identified a subpopulation of patients who benefited from the treatment with TG4010 and chemotherapy. 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 2 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).

TG4010 is currently being evaluated in TIME, a phase 2b/3 trial in NSCLC. Novartis has an exclusive option for an exclusive licence on the therapeutic vaccine.

JX-594/TG6006: A Multi-MechanisticApproach To Targeting Cancer

JX-594/TG6006 is a n engineered oncolytic virus that is designed to selectively target and destroy cancer cells. JX-594/TG6006 is designed to attack cancer through three diverse mechanisms of action: 1) the lysis of cancer cells through viral replication, 2) the shutdown of the blood supply to tumors through vascular targeting and destruction, and 3) the stimulation of the body's immune response against cancer cells, i.e., active immunotherapy. Phase 1 and phase 2 clinical trials in multiple cancer types to date have shown that JX-594/TG6006, delivered either directly into tumors or intravenously, induces tumor shrinkage and/or necrosis and is well-tolerated by patients (over 130 treated to date). Objective tumor responses have been demonstrated in a variety of cancers including liver, colon, kidney, lung cancer and melanoma.

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 development: 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 transgene.fr.

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.

Contacts:

Transgene

MC Services

Philippe Archinard, CEO

Raimund Gabriel

Phone: +33 (0)3 88 27 91 22

Phone: +49 89 210 228 30

Stéphane Boissel, Executive Vice President & CFO

Shaun Brown

Phone: +33 (0)3 88 27 91 02

Phone: +44 207 148 5998

Elisabetta Castelli, Director IR

Phone: +33 (0)1 44 08 55 05


Valeur associée
  Libellé Bourse Dernier Var. Vol.
Vous devez être membre pour ajouter des commentaires.
Devenez membre, ou connectez-vous.
Aucun commentaire n'est disponible pour l'instant