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A novel Ebola virus disease treatment based on three monoclonal antibodies will advance in development through an agreement between the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Regeneron Pharmaceuticals, Inc. of Tarrytown, N.Y.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide up to a total of $38 million over the next 23 months to support development as well as manufacturing of the experimental monoclonal antibody therapeutic drug for use in studies. These monoclonal antibodies bind to a key Ebola viral protein and neutralize the virus, decreasing the amount of virus in the body that the patient's immune system has to fight.
Regeneron generated the fully human Ebola monoclonal antibodies using their proprietary VelociGene and VelocImmune technologies which manufactured the antibodies in a specialized proprietary line of mammalian cells. These technologies allowed for rapid discovery, development and production of monoclonal antibodies, which makes the system potentially well suited for generating therapeutic drugs during public health emergencies when turnaround time is critical.
As an option under today’s contract, more of the therapeutic drug can be manufactured for future development studies. The work conducted through this program will support filing of an investigational new drug application with the Food and Drug Administration. BARDA also could provide an additional $11.3 million to manufacture alternative monoclonal antibodies.
“The world has experienced the worst Ebola epidemic in history; by rapidly developing therapeutics and vaccines with nimble technologies, we may save lives and bring future outbreaks under control more quickly,” says BARDA director Robin Robinson, PhD. “Regeneron’s technology facilitated the discovery and development of this monoclonal antibody therapeutic candidate in real time in just nine months as compared to the normal development cycle of several years, and the technology may have potential applications in future public health responses.”
The Regeneron monoclonal antibody therapeutic candidate is BARDA’s latest development project in the global response to the Ebola epidemic in West Africa. BARDA has worked with industry and federal interagency partners to develop multiple monoclonal antibody and small molecule therapeutic drugs, Ebola vaccine candidates to protect against the virus, and a rapid point-of-care diagnostic test for Ebola virus disease.
HHS enhances and protects the health and well-being of all Americans by providing for effective health and human services and fostering advances in medicine, public health, and social services. 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.
Within ASPR, BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.