Biotest AG, Dreieich, Germany and EpiVax, Inc., Providence, Rhode Island, USA are pleased to announce a new Collaborative Research Agreement. With this collaboration a novel, non-immunogenic Factor VIII (FVIII) should be developed. The coagulation factor VIII used for Hemophilia therapy will be altered in such a way that the immune system of the patients may not respond by developing inhibitory antibodies. The formation of inhibitory antibodies against the Coagulation factor VIII reduces its efficacy and may lead to severe bleeding disorders. Immunogenicity suppression will be also achieved through integration of EpiVax' proprietary Tregitope, an immune-modulating technology, with the FVIII treatment.
A tolerized and de-immunized version of factor VIII would allow patients and their families to experience the benefits of FVIII treatment, which does not induce a reaction of the immune system (no immunogenicity) without the fear of developing inhibitory antibodies ("inhibitors") against the therapeutic factor VIII. Studies carried out by EpiVax and collaborators indicate that Tregitope may be useful for reducing the antibody formation (inducing tolerance) to transplants, protein drugs, and allergens by "Tregitopes" (http://bit.ly/Tregi-Pubs). This announcement marks the initiation of the joint program, which is in the pre-clinical phase of development.
"This is an entirely novel approach to improving factor VIII therapy. In addition, a whole range of other biologics such as toxins and monoclonal antibodies might also benefit from the same approach." said Anne De Groot, M.D., President and CEO of EpiVax. "The development of "inhibitors" is a life-threatening complication with a profound impact on patients' lives. We want to make it possible to avoid the most serious side effect of today's hemophilia treatment.–" added Jorg Schuttrumpf, M.D., Senior Vice President of Global Research at Biotest.
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