TRANSGENE S.A. (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies, announces that the first patient has been dosed in a Phase 1 clinical trial in China, evaluating T101, a therapeutic vaccine based on Transgene’s immunotherapy technology for the treatment of chronic hepatitis B virus (HBV) infection. This product is a viral vector expressing the same suite of patented HBV antigens as in TG1050, currently in clinical development in Europe and North America.

T101 is being developed in China through Transgene’s joint-venture with Tasly Pharmaceutical Group Co, Ltd. This Chinese corporation was created in 2010 to develop biotechnology products, including Transgene products, in China. This company is jointly owned (50%/50%) with Tasly Pharmaceutical Group Co, Ltd, which is based in Tianjin, China.

The Phase 1 trial is a randomized, single-center, double-blind, placebo-controlled study evaluating T101 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy. The primary objective of this study is to validate the tolerability of T101 administered in single and multiple ascending doses. The trial will also evaluate the immunogenicity of the therapeutic vaccine in a patient population whose characteristics differ from European and North American patients (e.g. different modes of contamination, different population haplotypes), and who can be infected with different genotypes of the virus. This trial will include up to 36 patients. The first data readout from the study is expected at the beginning of 2019.

Currently available antiviral treatments can control the chronic hepatitis B but not cure the disease. Even under chronic treatment, patients still have a high probability to develop cirrhosis and liver cancer. In China, 500,000 patients could benefit from a better therapeutic option.

T101 is a targeted immunotherapy candidate for the treatment of chronic hepatitis B, based on a viral vector expressing three HBV antigens. It has been designed by Transgene’s infectious diseases research team, based on the technology of Transgene’s therapeutic vaccine TG1050.
TG1050 is currently being evaluated by Transgene in a Phase 1/1b trial with TG1050 in chronic HBV patients treated with standard-of-care antiviral therapies in Europe and Canada. The first results from this clinical trial have confirmed the good tolerability profile of TG1050. This study has also demonstrated the dose-related immunogenicity of this novel therapeutic vaccine following a single administration to patients with chronic hepatitis B receiving standard antiviral therapy. Additional data on patients receiving multiple doses of TG1050 are expected to be presented at a major international conference dedicated to liver diseases in H1 2018.