Transgene Announces Data on TG1050 Presented at Recent Medical and Scientific Conferences

Regulatory News :

Transgene SA (Paris:TNG) (NYSE-Euronext: TNG) today announced that pre-clinical data on TG1050, a targeted immunotherapy candidate for the treatment of chronic Hepatitis B (CHB), were presented recently at two major scientific and medical meetings.

An oral presentation entitled, "TG1050, a viral-vector based immunotherapeutic designed to treat chronic Hepatitis B induces immune responses with properties similar to those displayed by HBV resolving patients and has an early antiviral effect in a HBV tolerant model,” was given by Geneviève Inchauspé, Ph.D., Department Head, Infectious Diseases at Transgene on November 3, 2013 at the 64^th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, DC.

The presentation featured a summary of pre-clinical data regarding the potential of TG1050 to treat patients with CHB. The data included new results from an in vivo model that demonstrated the proper functioning of T cells (important cells of the immune system) following treatment with TG1050.

Geneviève Inchauspé said: "The pre-clinical data we have presented continue to support the potential of TG1050 for treating patients suffering from chronic Hepatitis B, an infectious disease causing over a million deaths each year worldwide. Importantly, the data indicate that TG1050 has the potential to be active across various genotypes of this disease, including those most common in Europe, the U.S., as well as China”.

An oral presentation entitled "Cross-reactivity studies of an immunogenic fusion sequence show potential for the development of a novel pan genotypic immunotherapeutic to treat chronic Hepatitis B,” was given recently at the 2013 International Meeting on Molecular Biology of Hepatitis B Viruses in Shanghai, China. This presentation was given by Ren Zhu, Ph.D., Senior Scientist, Head of the HBV Program at Transgene's China subsidiary, Transgene Biopharmaceutical Technology (Shanghai) Co., Ltd.

Dr. Zhu presented detailed pre-clinical data supporting the potential utility of TG1050 across a number of genotypes of HBV. TG1050 expresses a gene sequence from genotype D, common in Europe. The data presented showed that this sequence can induce immune responses capable of recognizing antigenic sequences from genotypes B and C, the most prevalent in China. Equivalent data has also been generated with respect to genotypes A and E. These findings support the potential for TG1050 to be developed to treat CHB patients irrespective of genotype, which may facilitate the development of TG1050 for a number of markets.

About TG1050

TG1050 is an adenovirus-based targeted immunotherapy candidate for the treatment of CHB.

CHB is a significant unmet medical need in the infectious disease space causing 1-1.2 million deaths per year. Overall, less than 10% of patients are cured, leading to the need to take lifelong antiviral therapies for most patients.

The pre-clinical package for TG1050 is indicating the capacity of TG1050 to induce robust, broad, long-lasting and cross-reactive T cells with characteristics similar to those found in patients who resolve infection, together with some antiviral activity. Pharmaceutical development and preparation for toxicity studies are currently ongoing. Transgene expects to initiate a first-in-humans clinical trial in late 2014. TG1050 is being developed for the Chinese market by Transgene Tasly (Tianjin) Biopharmaceutical Co., Ltd., a 50:50 equity joint venture between Transgene and Tasly Pharmaceutical Group Co., Ltd.

About Transgene:

Transgene, a member of the Institut Mérieux Group, is a publicly traded French biopharmaceutical company focused on discovering, developing and manufacturing targeted immunotherapies for the treatment of oncology and infectious diseases. Transgene’s programs utilize well-tolerated viruses with the goal of indirectly or directly killing infected or cancerous cells. The Company’s four clinical-stage programs are: TG4010 for non-small cell lung cancer; Pexa-Vec for liver cancer; TG4001 for oropharyngeal cancer (under a collaboration agreement with the EORTC) and TG4040 for chronic Hepatitis C. Transgene has concluded corporate strategic agreements for the development of two of its immunotherapy products: an exclusive option agreement with Novartis for the development and commercialization of TG4010 and an in-licensing agreement with US-based Jennerex, Inc. for the development and commercialization of Pexa-Vec in certain territories. The Company also has several programs in research and pre-clinical development that are based on its core viral vector technology. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S. Additional information about Transgene is available at www.transgene.fr.

Disclaimer:

This press release contains 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 but is not limited to the following factors: positive pre-clinical data may not be predictive of clinical results in humans, the success of clinical studies, the ability to obtain financing and/or partnerships for product 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, which is available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr).

Société anonyme au capital de 72.886.317 € – R.C. Strasbourg B 317 540 581
400 boulevard Gonthier d’Andernach – Parc d’Innovation - CS80166 – 67405 ILLKIRCH GRAFFENSTADEN CEDEX (France)
Tél : + 33 (0)3 88 27 91 00 - Fax : + 33 (0)3 88 27 91 11