February 4, 2020
HHS, Regeneron Collaborate to Develop 2019-nCoV Treatment
To develop therapeutics to treat the 2019 novel coronavirus, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) will expand an existing collaboration with Regeneron Pharmaceuticals Inc. of Tarrytown, New York.
"Emerging infectious diseases can present serious threats to our nation's health security," said Rick Bright, Ph.D., deputy assistant secretary for preparedness and response and director of the Biomedical Advanced Research and Development Authority (BARDA) at ASPR. "Working as public-private partners like we have with Regeneron since 2014, we can move rapidly to respond to new global health threats."
BARDA and Regeneron now will leverage their partnership agreement to develop multiple monoclonal antibodies that, individually or in combination, could be used to treat this emerging coronavirus, also known as 2019-nCoV.
These monoclonal antibodies are produced by a single clone of cells or a cell line with identical antibody molecules. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells. Medicines developed for 2019-nCoV through the expanded BARDA-Regeneron partnership will leverage Regeneron's monoclonal antibody discovery platform called VelocImmune, part of the company's VelociSuite technology.
VelociSuite was used to develop a promising investigational three- antibody therapeutic which was deployed to treat Ebola in the most recent outbreak in the Democratic Republic of the Congo, and an investigational two-antibody therapeutic to treat Middle East Respiratory Syndrome coronavirus (MERS-CoV). The technology shortened multiple aspects of the product development timeline for therapeutics to treat MERS-CoV and Ebola from years to months. The technology helped shorten certain stages of drug development, including the process of antibody discovery and selection, preclinical-scale manufacturing and clinical-scale manufacturing.
In addition to expanded collaboration with Regeneron, BARDA is working with counterparts across the government, including within HHS and with the Department of Defense. The team is reviewing potential vaccines, treatments and diagnostics from across the public and private sectors, particularly products in development for MERS or Severe Acute Respiratory Syndrome (SARS), to identify promising candidates for development to detect, protect against or treat 2019 nCoV.
To obtain information about any potential products in development in the private sector that could be used in responding to 2019-nCoV, the U.S. government on Friday launched a single point of entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies relevant to this new virus. Federal agencies are particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, or utilize a platform already approved by the U.S. Food and Drug Administration (FDA).
HHS Secretary Alex Azar declared a nationwide public health emergency January 31 to aid state health departments' efforts to curb the spread of the virus in the United States. On January 30, 2020, the World Health Organization identified the current outbreak of 2019-nCoV as a Pandemic Health Emergency of International Concern. There are currently no FDA-approved vaccines to protect individuals or FDA-approved medicines to treat individuals who may become ill from 2019-nCoV infections.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, devices, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. Since 2007, 53 BARDA-supported products have achieved regulatory approval. For more about ASPR and BARDA, visit www.phe.gov/aspr, and to learn more about partnering with BARDA, visit www.medicalcountermeasures.gov.