A Monoclonal Antibody Immunoprotectant for Ebola Virus

DESCRIPTION (provided by applicant): The primary focus of this proposal is development of a product for protection against Ebola virus (Category A agent). Through collaboration between Mapp Biopharmaceutical and Dr. Mary Kate Hart (USAMRIID), three murine monoclonal antibodies (Mabs) that were found to have protective efficacy in a murine model of Ebola infection have been humanized. These humanized Mabs retain their efficacy in mice. The goal of this proposal is to test these Mabs in a non-human primate efficacy model. In the first Specific Aim of this proposal, high-producing CHO cell lines expressing the three Mabs will be generated and used to produce gram quantities of Mab for macaque experiments. The second Specific Aim will be to test the efficacy of these Mabs in the macaque Ebola virus model. A future Phase 2 submission will propose manufacturing and formulating the product under cGMPs, completing all IND-enabling studies, submitting an IND, and testing the safety of the product in human volunteers. The efforts in this proposal will help in the development of a drug for preventing and/or treating Ebola virus, a potential biowarfare agent, for which no treatment currently exists.