ASPR awards $110 million to advance development, procure therapeutic for Sudan ebolavirus
The Administration for Strategic Preparedness and Response (ASPR) today announced a $109.8 million contract with Mapp Biopharmaceutical Inc., for the advanced development and potential purchase of a monoclonal antibody therapeutic to treat Sudan ebolavirus (SUDV).
Using authority under the 2004
Project BioShield Act, the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR within the U.S. Department of Health and Human Services, will work with Mapp Biopharmaceutical Inc. of San Diego, California, on advanced development of MBP134, a combination of monoclonal antibodies.
“One of the ways we enhance the nation’s readiness for health emergencies is by investing in medical countermeasures for which there is no commercial market,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “The funding being provided by BARDA will advance this research. If approved this treatment will put the U.S. in a better position to prepare for and respond to future potential ebolavirus incidents. Given the current outbreak of Ebola Sudan in Uganda, this work is now even more important.”
In 2006, the Department of Homeland Security determined ebolavirusesto be a material threat to national security. No products are approved to treat SUDV infections; the vaccines and therapeutics developed and supported by BARDA and other partners in the U.S. government to treat a different species, Zaire ebolavirus, have not been studied or approved for prevention or treatment of Sudan virus disease.
Given the four reported SUDV outbreaks since 2000, including the current outbreak in
Uganda, developing therapeutics that address SUDV infections is critical to U.S. public health preparedness.
In laboratory studies to date, MBP134 also demonstrated efficacy against other filoviruses, including
Zaire ebolavirus and
Bundibugyo ebolavirus, suggesting that it may have the potential to serve as a broad-spectrum Ebolavirus countermeasure.
This award follows Advanced Research and Development awards BARDA previously issued to Mapp Biopharmaceutical to develop MBP134. Those contracts supported late-stage product optimization, manufacturing, IND submission, and a first in human clinical trial.
The funding under this new award supports activities necessary to request regulatory approval of MBP134, including support for manufacturing, efficacy and safety evaluations, and regulatory submissions. Under the contract, the company will develop a lyophilized (freeze-dried) formulation of MBP134 to help reduce the need for cold-chain storage and make transporting the therapeutic easier worldwide.
If the product receives U.S. Food and Drug Administration approval as a treatment for Sudan virus infection, BARDA will purchase the product for use in the United States as needed.
MBP134 is the first SUDV therapeutic in
BARDA’s portfolio. Visit the
CBRN portfolio to learn more.
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