Transgene (Euronext Paris: FR0005175080) today announced that it has achieved pre-clinical proof of concept with a new therapeutic vaccine candidate, TG1050, aiming at treating chronic infection by the hepatitis B virus ("HBV"). Positive pre-clinical data supports further development of the product. These data include:
- Robust and broad immune (T cell) response in pre-clinical models after one or more injections;
- Potent in vivo cytolysis1 against several epitopes(2); and
- Genetic stability of the vaccine.
Despite the introduction in the past decade of efficacious new drugs (Nucleoside analogs - "NUCs"- and PEG-IFNa) to treat CHB, these drugs result only rarely in the resolution of the infection, which is defined by the disappearance of circulating hepatitis B virus surface antigen ("HBsAg") and a measurable antibody response against this same antigen, or HBsAg seroconversion 3. In combination with standard of care, TG1050 has the potential to increase the level of seroconversion in comparison to current treatments, and thus could provide a new option for the cure of the infection.
The product is expected to enter clinical development in 2014.
"The promising preclinical proof of concept on this new vaccine candidate, together with the clinical efficacy data obtained with TG4040, our therapeutic vaccine against hepatitis C, proves again the excellence of Transgene’s research in the field of infectious diseases"
said Philippe Archinard, Chairman and CEO of Transgene. He added: "Although the management of CHB has significantly improved over the past decade, the long-term control of the infection is very rarely achieved and patients have to endure decades-long treatments. We believe that a combination of TG1050 with the standard of care could potentially help to cure the infection, providing relief to millions of patients".
Transgene’s HBV research program will be presented today in a poster at the EASL congress (European Association for the Study of Liver), in Barcelona, Spain. During the same EASL congress (on April 21, 2012), Pr. Heiner Wedemeyer, MD, of the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School (Germany), will give a "late breaker" oral presentation and present follow up data from the randomized Phase 2b clinical trial with TG4040, a therapeutic vaccine against chronic hepatitis C infection for which initial proof of concept data were released at AASLD in November 2011.