July 20, 2015
HHS partnership advances experimental Ebola drug
One of the nation’s centers dedicated to developing and manufacturing drugs and vaccines for emergencies will produce a novel therapeutic drug to treat Ebola virus disease under a task order issued by the U.S. Department of Health and Human Services (HHS). This is the first task order to a Center for Innovation in Advanced Development and Manufacturing (CIADM) and will support the ongoing global public health response to the Ebola epidemic in West Africa.
“Preventing, detecting and treating Ebola infections remain critical not only for the current epidemic in West Africa but also to minimize the impacts of future outbreaks,” explained Robin Robinson, Ph.D., director of HHS’ Biomedical Advanced Research and Development Authority (BARDA), the office that will oversee the program. “The development of this experimental drug represents significant progress in making Ebola therapeutics available. Our CIADM partners have the expertise, capacity, and state-of-the-art facilities required to make promising therapeutic candidates quickly.”
Under the two-year, $19.7 million task order from BARDA, Emergent BioSolutions of Gaithersburg, Maryland, will begin advanced development and manufacturing activities for an experimental monoclonal antibody drug at its Baltimore Bayview CIADM.
The Emergent facility is one of three CIADMs established as public-private partnerships with BARDA in 2012 to respond rapidly to national needs for medical countermeasures. Over the last three years, the CIADM partners have been designing and building the necessary physical infrastructure, including facilities and manufacturing lines, for the CIADMs.
Under this first task order to a CIADM, Emergent will transfer manufacturing processes and materials from the early-stage development work of other companies on this experimental drug to the CIADM to begin advanced development. Emergent also will manufacture the experimental drug for use in nonclinical and clinical studies and will conduct the work necessary to scale up production to commercial volumes if studies prove successful.
The experimental drug is similar to ZMapp, made by Mapp Biopharmaceuticals of San Diego using tobacco plants. This new drug uses a combination of the same three monoclonal antibodies as ZMapp, but is produced using special mammalian cells rather than tobacco. Monoclonal antibodies bind to key viral proteins and neutralize a virus, decreasing the amount of the virus in the body that the patient's immune system has to fight.
Because large quantities of cell-based monoclonal antibodies can be produced more quickly than tobacco-based monoclonal antibodies, this CIADM project will provide more product for clinical studies and, if clinical studies are successful, for potential stockpiling.
The CIADMs were established in the wake of the 2009 H1N1 influenza pandemic and are a component of BARDA’s National Medical Countermeasures Response Infrastructure that provides core services for private partners to speed development, manufacturing and availability of drugs, vaccines and medical devices including diagnostic tests. Additional core services available through this response infrastructure include a nonclinical studies network, a clinical studies network, and a fill-finish manufacturing network.
The National Medical Countermeasures Response Infrastructure and development of Ebola therapeutic drugs are part of BARDA’s integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance.
BARDA is part of HHS’ Office of the Assistant Secretary for Preparedness and Response
(ASPR). ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about Ebola, visit www.cdc.gov/ebola and for more about preparedness, response and recovery from the health impacts of emergencies, visit the HHS public health and medical emergency website, www.phe.gov. Information about medical countermeasures is available at www.medicalcountermeasures.gov.