Date: 2013-10-22
Type of information: R&D agreement
Compound: epicutaneous delivery of recombinant Factor VIII (FVIII) protein via Viaskin
Company: DBV Technologies (France) Inserm (France) Inserm Transfert (France)
Therapeutic area: Genetic diseases - Hematological diseases - Rare diseases
Type agreement: R&D
Action mechanism:
Disease: hemophilia A
Details: * On October 22, 2013, DBV Technologies has announced that it has entered into a research collaboration with Institut national de la Santé et de la recherche médicale, Inserm and Inserm Transfert, to investigate the effect of epicutaneous delivery of recombinant Factor VIII (FVIII) protein via Viaskin® in an animal model of hemophilia A. DBV and Inserm are teaming up to combine the Viaskin® technology and a world-class expertise in hemophilia A to develop a potential standard of care for refractory hemophilia A patients, by providing a cost-effective, and non-invasive treatment. The protective effect conferred by the immunological response induced by epicutaneous immunotherapy using Viaskin® will be tested at the humoral level, and is expected to induce tolerance to FVIII in mice with severe hemophilia A. The DBV-Inserm research collaboration will last 12 months. Different mice cohorts will be treated with Viaskin® containing the FVIII protein versus placebo for 45 days. After 45 days, all mice will be subject to a protocol of replacement therapy for 4 weeks. The levels of anti-FVIII IgG and of FVIII inhibitors will then be assessed by immunological and functional assays. Various approaches have investigated treatments aimed at inducing tolerance to exogenous FVIII in hemophilic mice. Through the Viaskin platform, DBV Technologies has developed a first-in-class approach to deliver antigens of choice to immuno-sensitized organisms as a method to induce antigen-specific tolerance, and in this case, tolerance to therapeutic FVIII in hemophilia A.
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