Berlin, 6 April 2010. The Berlin based biotechnology company MOLOGEN AG has received funding for the pre-clinical development of a MIDGE®-based vaccine against hepatitis B. The project has already commenced and is being carried out jointly with Synvolux Therapeutics B. V., a company based in the Netherlands.

 

The project's aim is to develop a new and highly effective vaccine against infection through hepatitis B viruses. The vaccine is to be available for preventative (prophylactic) use as well as for treatment (therapeutic use). All the necessary pre-clinical studies will be carried out so that by the end of the project the vaccine will be available for testing in clinical trials.

 

The project is being funded by the German Federal Ministry of Education and Research, as part of the EU's EuroTrans-Bio initiative, with around 280,000 euros, which equates to a 50% share of funding. The project is to be concluded by the end of 2012.

 

At the end of the project the vaccine is then to undergo testing in clinical studies.

 

"The funding enables us to develop a further MIDGE-based vaccine product for a disease where an improved method of treatment has always been a major medical need", said Dr. Matthias Schroff, the Chief Executive Officer of MOLOGEN AG. "Within the new project we will be developing another modern DNA vaccine based on one of our key technologies to add to the vaccine against leishmaniasis in humans, which also received significant funding. As well as our expertise in combating cancer, we can now demonstrate our extensive ability in the development of DNA-based vaccines, and further expand our product pipeline."

 

DNA vaccine against hepatitis B viruses

The new type of vaccine is based on the MIDGE® DNA vectors from MOLOGEN and is formulated with the well tolerated SAINT transfection reagent from Synvolux, which acts as an adjuvant.

 

The new DNA vaccine is to increase efficacy over existing vaccines and decrease the current requirement for repeat vaccinations per person. It is to be available as a prophylactic as well as for therapeutic uses. The new vaccine enables a reduction in vaccine costs as well as making the implementation of vaccine programs easier.

 

About hepatitis B

Hepatitis B is a serious disease of the liver following infection from hepatitis B viruses. Globally there are around 2 billion infected people of which around 350 million suffer from chronic hepatitis B.

 

In approximately 90% of cases the infection is acute and heals within two to six weeks. Around two thirds of all those infected with hepatitis B present no clinical symptoms. Serious cases can lead to acute liver tissue damage as well as blood coagulation disorders and brain damage.

 

Around 10% of infections develop into chronic disease. This can have serious consequences such as liver cirrhosis or cancer of the liver. The younger the infected person, the more likely the development of a chronic disease. Therefore in most countries there is a public vaccination program for newborns and young children.

 

Although there are already many approved vaccinations available, there is still demand for new types of hepatitis B vaccinations. These are intended to provide, for example, single dosage immunization (up to now three vaccinations are usually required) as well as being suitable for therapeutic purposes.

 

MIDGE® DNA vectors

MOLOGEN MIDGE® vectors are an excellent platform on which to develop well tolerated DNA-based vaccines. In contrast to other DNA vectors (plasmids, viruses), the MIDGE® vector contains only the required information for the actual action. It is free of any undesirable structures that are only useful within the manufacturing process. MIDGE® vectors are around 50-80% smaller than current plasmid-based DNA vectors and even considerably smaller than viral vectors.

 

MIDGE® vectors are non-toxic and non-inflammatory even when administered in dosages that far exceed what is clinically relevant. MIDGE® vectors do not trigger immune reactions and, more importantly, the vector is not integrated into the patient’s genetic make-up. MIDGE® vectors therefore provide a safe and efficient prophylactic or therapeutic gene expression.

 

MIDGE® vectors from MOLOGEN thus overcome the efficacy and safety disadvantages of other gene transfer and expression systems.