Agreements

* On December 3, 2013, Biotest, a german provider of plasma proteins and biotherapeutic drugs, and EpiVax have announced 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. 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. Epitope Presentation Tregitopes are linear sequences of amino acids contained within the framework of a common serum protein known as immunoglobulin G. Tregitopes act as a natural immune system ‘off switch” and have been shown in standard preclinical models, to “reset” the immune response away from immunogenicity and towards tolerance. In the current collaboration, EpiVax and Biotest scientists will use Tregitopes to selectively dampening unwanted immune responses to factor VIII, the primary therapeutic used to control bleeding for individuals who have hemophilia A. This announcement marks the initiation of the joint program, which is in the pre-clinical phase of development.