French biopharmaceutical company Transgene has randomised its first patient in the multiple-dose cohort of its Phase I/Ib trial of TG1050 to treat chronic hepatitis B virus (HBV) infection.
TG1050 has been developed as a targeted immunotherapy candidate indicated for the treatment of chronic hepatitis B, based on a viral vector expressing three HBV antigens.
Hepatitis B is a malignant liver infection caused by HBV infection, which can result in chronic infection and liver disease.
The condition can lead to death from cirrhosis of the liver and liver cancer if left untreated.
The Phase I/Ib trial is a first-in-man study conducted as an international, randomised, multi-centre, double-blind, placebo-controlled study.
It is intended to evaluate TG1050 in patients who are currently undergoing treatment for chronic HBV infection with standard-of-care anti-viral therapy.
The study is primarily focused on assessing the safety and tolerability of TG1050 while being administered in single and multiple doses, as well as determining the dose and schedule of the immunotherapy candidate for further development.
The secondary goals of the study are to determine the antiviral activity of and immune responses triggered by TG1050.
TG1050 has demonstrated its efficacy in inducing robust, broad and long-lasting HBV-specific T-cells, as well as exhibiting its anti-viral effects such as seroconversion to the surface antigen (HBsAg).