MappBio Announces Contracts with BARDA for ZMappTM and Additional Filovirus Medical Countermeasures
Sep 29, 2017—(SAN DIEGO, CA)— Mapp Biopharmaceutical, Inc., announced today that it has been awarded a Project BioShield contract (HHSO100201700017C) of approximately $46 million by The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance ZMappTM to licensure by the Food and Drug Administration (FDA). A separate contract (HHSO100201700023C) of $1.9 million has been awarded (with options for an additional $6.6 million) to support Mapp’s preclinical stage products for Sudan virus (MBP134) and pan-Marburg virus (MBP091).
ZMapp is a monoclonal antibody cocktail for the treatment of Ebola Virus Disease (EVD) that has yielded promising safety and efficacy data from animal models and the PREVAIL II clinical trial conducted during the 2013-2016 outbreak in West Africa. ZMapp is currently being made available to EVD patients through an Expanded Access Protocol offered to sites in the United States, Guinea, Liberia, and Sierra Leone.
The Project BioShield contract involves a five-year commitment, with options for an additional $297 million of funding that could extend the agreement an additional five years, and separate options for procurement of ZMapp for the Strategic National Stockpile.
“We are pleased to continue our productive relationship with BARDA, and believe both these programs represent strong examples of public-private partnership to advance much needed therapeutics for patients and the Strategic National Stockpile,” said Dr. Kenneth G. Payie, Chief Operating Officer and Principal Investigator on the ZMapp contract.
MBP134 and MBP091 are monoclonal antibody products with unprecedented therapeutic efficacy in non-human primate models of Sudan and Marburg virus infection, respectively. Sudan and Marburg are viruses from the same family of viruses, Filoviridae, as Ebola. Like Ebola, they cause disease characterized by severe hemorrhagic fever and high mortality. “This award will allow us to advance these molecules to be better prepared for future outbreaks,” said Dr. Ellen Monson, Senior Advisor and Principal Investigator on the Sudan/Marburg contract.
“Together, these two awards are a credit to the productivity and success of the Mapp team, and also highlight the potential of monoclonal antibodies to address even the most challenging of infectious disease threats to public health,” said Dr. Larry Zeitlin, President.
About Mapp Biopharmaceutical and LeafBio: Mapp Biopharmaceutical was founded in 2003 to develop novel pharmaceuticals for the prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense. As these products transition to clinical evaluation, LeafBio assumes ownership and commercialization responsibilities.
These projects have been funded in part with federal funds from the Department of Defense under Contract No. HDTRA1-13-C-0018, the Department of Health and Human Services; National Institutes of Health (AI061270, AI109762) and Office of the Assistant Secretary for Preparedness and Response; and Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400009C. HHSO100201600021C.