The Biomedical Advanced Research and Development Authority (BARDA) today took an exciting next step in implementing a three-prong strategy to develop, manufacture, test, and make available Ebola monoclonal antibody therapeutic candidates as part of the U.S. Ebola response. BARDA now is partnering with Medicago and Fraunhofer to produce Ebola monoclonal antibodies similar to ZMapp from Mapp BioPharmaceuticals to study efficacy in nonhuman primates and then potentially for clinical studies in humans.

These studies will help to determine whether Ebola monoclonal antibodies produced by other tobacco biopharmaceutical companies are as effective as ZMapp. ZMapp is now entering clinical trials in West Africa. If they are as effective, the U.S. could increase the overall manufacturing capacity for ZMapp and similar products.

Medicago is a Canadian company that develops and produces plant-based vaccines and therapeutics; Fraunhofer is a non-profit research and development organization. They will utilize their own proprietary tobacco expression systems in producing the antibodies, which will be compared to ZMapp. BARDA is collaborating with the Department of Defense using existing DoD contracts with Medicago and Fraunhofer to expedite the manufacturing of the product for use in studies and to conduct the animal studies.

BARDA has taken other steps to implement the three-prong strategy:

• Supporting Mapp BioPharmaceuticals in developing and manufacturing ZMapp for clinical trials.
• Partnering with Regeneron and Genentech to develop and manufacture new Ebola monoclonal antibodies using specialized CHO mammalian (Chinese hamster ovary) cell lines for nonhuman primate studies and potentially clinical studies.

Together these three prongs will help make safe, effective therapeutics – known as monoclonal antibody therapeutics – available as quickly as possible in the ongoing fight against Ebola. Since the beginning of the Ebola outbreak in West Africa, BARDA has been working with our private industry partners to explore all possible means to speed development and production of therapeutics and vaccines. We are leaving no stone unturned.