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CyTuVax starts Phase I Clinical trial with the
HBAI20 Hepatitis B vaccine for Non-responders

Press release


Effective vaccination for persons that do not respond to standard Hepatitis B vaccines

Maastricht, The Netherlands, 01 November 2015 – CyTuVax, a life science company focusing on the development of cancer, viral and bacterial vaccines, today announced the start of a phase I clinical trial assessing the safety and efficacy of its lead product, a Hepatitis B HBAI20 vaccine for non-responders to standard Hepatitis B vaccines. This trial will be conducted at the Ease Travel Clinic by the Department of Medical Microbiology of the MAASTRICHT UMC and is coordinated by Dr. A.M. L. Oude Lashof, MD PhD, Internist and Consultant Infectious Diseases of Maastricht UMC. The trial, for which 36 subjects are being recruited, started in October 2015 and data are expected to be published in Q3 of 2016.

Hepatitis B is an infectious disease caused by the hepatitis B virus (HBV), and could lead to acute or chronic liver inflammation that might trigger liver failure and liver cancer. Many people have no symptoms during the initial infection. Worldwide an estimated 360 million people are chronically infected, of whom almost one million people die annually of HBV-related liver disease. Chronic hepatitis B is the major cause of hepatocellular carcinoma (HCC), the most common type of liver cancer. The disease occurs in particular in Africa, south of the Sahara and in East Asia, where around 10% of the adults are chronic carriers of the virus.

Extra stimulus of immune system for non-responders

Safe and effective HBV vaccines have been available since 1982. The implementation of effective vaccination programs has resulted in a significant decrease in the incidence of chronic hepatitis B infection. Nevertheless, about 5% of the total population does not respond to the standard HBV vaccination. They do not built-up a protective antibody titer against HBV and represent the so-called ‘non-responders’.

For these non-responders CyTuVax developed the HBAI20 vaccine. The HBAI20 vaccine consists of a standard HBV vaccine to which the CyTuVax’ AI20 adjuvant is added. This adjuvant is able to give an additional stimulus to the immune system and may provide sufficient protection against HBV for non-responders. In addition, the HBAI20 gives a faster protection offering the potential of less vaccinations in the future.

About Cytuvax

CyTuVax was founded in Maastricht in 2012 by dr. René Vleugels and prof. Frank W. Falkenberg. The company has developed a platform vaccination technology consisting of depot-attached cytokines as immune stimulator (adjuvant).

The vaccination technology has been specifically designed for cancer vaccination therapy. The distinctive feature of CyTuVax’ cancer vaccine is the improved maturation of dendritic cell precursors to CD86+ T-cells and transport of cytokine-micro-aggregates directly into the lymph node, which together forcefully stimulates the activation of T-cells and other immune cells.

The main focus in the field of oncology is on the development of the pancreas cancer vaccine PanCaVax, together with prof. Eric van Cutsem of the University Hospital in Leuven and prof. Waldemar Uhl of the Academic Hospital in Bochum. Another target is the development of a vaccine against melanoma, for which promising preclinical studies have been completed.

CyTuVax is also pursuing the development of viral and bacterial vaccines. In preclinical studies the effectiveness of the vaccination technology was demonstrated in animal models of hepatitis B, Anthrax, Tetanus- and Diphtheria toxoids. The cytomegalovirus (CMV), which constitutes a major problem in transplant recipients, is another candidate for development into a new vaccine product.