A biotech company that designs and develops virus-based immunotherapies, Transgene confirms dosing the first patient in a Phase 1 Clinical Trial in China, evaluating T101, therapeutic vaccine for treatment of chronic hepatitis B virus infection. This trial will include up to 36 patients. The first data readout from the study is expected at the beginning of 2019.
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 goal of this study is to testify the tolerance level 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.
Currently available antiviral treatments can curb 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 more suitable therapeutic alternative.