TG4040 is being developed to treat patients that are chronically infected with the hepatitis C virus.
Transgene’s TG4040 product candidate is based on the MVA virus carrying and expressing non-structural proteins (NS3, NS4 and NS5B) of the hepatitis C virus.
Hepatitis C currently represents a major public health concern. The number of people chronically infected with HCV is estimated at between 170 to 200 million people worldwide, and growing. Almost half a million hepatitis C related deaths occur each year. HCV infection leads to liver diseases such as fibrosis, cirrhosis and liver carcinoma which are the prime reasons for liver transplants. The current standard of care for patients infected with the HCV genotype 1 (a combination of pegylated interferon alpha and ribavirin) is lengthy, often poorly tolerated and effective in only 50 per cent of patients that complete therapy. Many patients receive no treatment at all and the medical need for new alternative approaches, including combination therapies, is extremely high.
TG4040 has completed two phase I trials in France and in Canada. The French trial involved 39 treatment naïve patients chronically infected with the genotype 1 HCV. The Canadian trial consisted of 11 patients with the same chronic HCV infection but who had relapsed after standard of treatment with Ribavirin and Pegylated-Interferon Alpha. The trials primary endpoints were safety and the secondary endpoints were immune response to the vaccinations, and overall effect on viral load.
Clinical results from both phase I trials show that the product is safe and well tolerated by patients at all dose levels. Immunological analyses on 15 patients involved in the French trial were very encouraging and supported the expected mechanism of action of TG4040, which aims at inducing an effective HCV-specific T cell based immune response, able to control viral replication. The final results of the French trial were presented at the EASL (European Association for the Study of the Liver) conference in April 2009 (see press release 23rd April 2009) and at the AASLD (American Association for the Study of Liver Diseases) meeting in November 2009.
Transgene has begun a phase II trial (named HCVac) of TG4040 in combination with standard of care, in July 2010. HCVac is a randomized, open-label, multi-site, international study that will enrol 140 patients chronically infected with genotype 1 HCV who have not been previously treated for their infection.
In 2006 Transgene was awarded a €1.3 million grant by the Lyonbiopôle Competitiveness Cluster for the development of TG4040 for patients infected with chronic hepatitis C. The funding, which originated from the French Ministry of Industry covered approximately 30 per cent of the research and development costs of the phase I program.
The phase I trial conducted in Canada was sponsored by the University of Montreal and supported by the Canadian Network for Vaccines and Immunotherapies.
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