Alimentary Tract and Metabolism
T101Indication——Chronic hepatitis B
T101 is a novel immunotherapeutic vaccine intended to treat chronic hepatitis B .T101 was initially developed by Transgene. Transgene is conducting simultaneous development of TG1050, a counterpart of T101 in France, across the globe. Transgene has completed TG1050’s Phase I clinical trials in Canada, France, and Germany ,which produced positive results. Transgene provides technical support for Transgene Tasly, which is responsible for implementing the development of T101 in China. Tasly Biopharma has the right to manufacture and sell T101 in China upon its commercialization.
Mechanism of Action
T101 is a vaccine using recombinant replication-defective adenovirus type 5 (“Ad5”) as the vector to carry three core antigen genes of HBV. T101 functions by inducing HBV-specific cytotoxic T cells (“CTL”) to kill infected liver cells; and inducing the production of cytokines (such as IFN- and TNF-) to neutralize the HBV (clear HBV through a non-cytolytic mechanism) in the infected liver cells.
The diagram below illustrates the mechanism of action of T101 ：
(1) The first immunotherapeutic vaccine using virus as the vector for hepatitis B that has initiated clinical trials in China;
(2) Expected to neutralize HBV infection thoroughly by inducing specific cellular immune response similar to the body’s mechanism of self-recovery from virus infection.
Through Transgene Tasly, Tasly Biopharma initiated the preclinical research of T101 in June 2014, submitted an investigational new drug (IND) application in January 2016, obtained IND approval in June 2017, and initiated its Phase I clinical trial in China in December of the same year; T101’s Phase II clinical trial was initiated in October 2019 and currently is still ongoing. The Phase II clinical trial is expected to be completed in September 2022.