VPM, Vakzine Projekt Management GmbH, together with GBF, the German Research Centre for Biotechnology, has licensed in its first project: a new, soluble beta-interferon that promises improved treatment of multiple sclerosis, the most common disease of the central nervous system. The substance – already patented in Germany and the United States – was studied and developed in the laboratory by the Hannover-based Gene Technology Department of the Fraunhofer Institute for Interfacial Engineering and Biotechnology (IGB) in Stuttgart. Under an exclusive, worldwide agreement, VPM will now carry out development up to proof of clinical effectiveness. The project management company, VPM, was set up last year by GBF under a program of the Federal Ministry of Education and Research (BMBF) in order to improve the commercial prospects of academic research on vaccine candidates and other immunological products.

Estimates put the number of people suffering from multiple sclerosis worldwide at about 2.5 million. Until today therapeutic successes have been achieved using natural beta-interferon. Biotechnology procedures make it possible to engineer this endogenous protein in bacteria or mammalian cells. “However,“ says Prof. Dr. Bernd Otto, now Professor at Hannover Veterinary University and previously head of the Gene Technology Department at IGB, “beta-interferon is not well soluble in water, which makes manufacturing difficult and diminishes the pharmacological efficacy of the drug. This is why we have altered the amino acid sequence of beta-interferon at nine positions,“ says Otto, “to genetically engineer a variant with improved water solubility. This variant offers a better bio-availability and is more stable.“ With this process, researchers hope to reduce unwanted side effects and increase the drug's efficacy. Furthermore, the new beta-interferon may find applications in the treatment of other diseases, such as viral infections or cancer.

Due to the broad spectrum of possible applications, beta-interferon enjoys substantial market potential. “The global market for beta-interferons last year was 2.4 billion U.S. dollars,“ says VPM Managing Director Dr. Albrecht Läufer, “and for 2007, market volume estimates go as high as 3.7 billion dollars.“ And Läufer notes,“if our expectations are met in the upcoming tests this new product will surely garner a share of that substantial market – a positive signal for the German biotechnology sector.“ VPM plans initially to test beta-interferon in pre-clinical and clinical trials, up to clinical phase IIa. If successful with the so-called “proof of concept“, VPM intends to continue development in the very complex and costly phases IIb and III with a partner from the pharmaceutical industry.

Project partners

Vakzine Projekt Management GmbH in Braunschweig organizes and finances the pre-clinical and clinical development of vaccines and related products nationwide.

The Fraunhofer Institute for Interfacial Engineering and Biotechnology develops solutions for business, industry and public agencies in the areas of health care, environment and technology. IGB headquarters are in Stuttgart with a branch office in Hannover.

The German Research Centre for Biotechnology in Braunschweig is the Helmholtz Centre for in-fection research and amongst others holder of the BMBF program “promoting development and commercialization of vaccines“.