Biotest-EpiVax Collaborative Research Targets New, Non-Immunogenic Treatment for Hemophilia A

December 3, 2013

Dreieich/ Germany, Rhode Island/ USA, 3 December 2013. 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 Jörg Schüttrumpf, M.D., Senior Vice President of Global Research at Biotest.

About Biotest
Biotest is a provider of plasma proteins and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has about 1.900 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

About EpiVax
EpiVax, Inc., located in Providence, Rhode Island, USA, is a biotechnology company focused on the development of vaccines and biologic therapies. EpiVax is one of the world’s leading innovators in the field of “Immunogenicity Screening”. The company uses proprietary immunoinformatics tools to screen protein therapeutics and to de-immunize these drugs so as to reduce adverse effects in the clinic. The Tregitope technology is an additional immune-modulating tool that is expected to improve tolerance of protein drugs such as replacement enzymes, blood factors, and monoclonal antibodies.

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