TRANSGENE Presents Preclinical Results Of TG1050, An HBV-Targeted Immunotherapy, At American Association for Study of Liver Diseases 2016 Liver Meeting

STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:

Transgene (Paris:TNG) (Euronext Paris: TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today presented a poster on TG1050 preclinical results at the AASLD (American Association for the Study of Liver Diseases) Liver Meeting 2016, Boston (MA). TG1050 is a therapeutic vaccine for the treatment of chronic hepatitis B (or HBV¹ infection).

The abstract published in Hepatology can be downloaded on the AASLD website (DOI: 10.1002/hep.28800). The poster is available on Transgene’s website.

Poster title: TG1050, an HBV-targeted immunotherapeutics, efficiently decreases HBV viremia and antigenemia in a preclinical model; a meta-analysis and the determination of the involvement of CD4 and CD8 T cells.

The poster shows a meta-analysis of preclinical data obtained with TG1050 in HBV persistent mice and preliminary data on the mode of action of TG1050.

Transgene scientists showed:

• A significant treatment effect on viremia and HBsAg (surface antigen of the hepatitis B virus) levels and a higher percentage of responders for viremia and HBsAg in TG1050-treated mice;
• That the period needed to observe a decrease in viral parameters is shorter in TG1050-treated mice;
• That some mice treated by TG1050 displayed anti-HBsAg antibody seroconversion (clinical goal of HBV therapies);
• The involvement of TG1050-induced HBV-specific CD8 and CD4 T cell responses in TG1050 antiviral effects.

Transgene is currently conducting a Phase 1/1b clinical study evaluating the safety and tolerability of TG1050 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy.

About TG1050

TG1050 is a targeted immunotherapy candidate for the treatment of chronic hepatitis B, based on a viral vector expressing 3 HBV antigens. Transgene has initiated a randomized, multi-center, double-blind, placebo-controlled safety and dose-finding first-in-man Phase 1 study (NCT02428400) evaluating the safety and tolerability of TG1050 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy. The technology of TG1050 is also being developed in China, where it is currently under SFDA evaluation and has been recently granted an IND number. In China, Transgene operates a joint-venture with Tasly Biopharmaceutical Technology.

The latest publications on TG1050 are available on: www.transgene.fr.

About Transgene

Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biopharmaceutical company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s two lead clinical-stage programs are: TG4010, a therapeutic vaccine for non-small cell lung cancer and Pexa-Vec, an oncolytic virus for liver cancer. The Company has several other programs, including TG4001, in clinical and preclinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a joint venture in China. Additional information about Transgene is available at www.transgene.fr.

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Forward-looking statements

This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, 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, available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

¹ HBV: hepatitis B virus