An investigational treatment for Ebola virus disease will receive advanced development support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide $14 million and expertise to Ridgeback Biotherapeutics of Miami to manufacture the therapeutic, mAb114, and support activities required to apply for licensure from the U.S. Food and Drug Administration (FDA).
The therapeutic is a single monoclonal antibody. Monoclonal antibodies bind to a virus protein, reducing the ability of the virus from infecting human cells.
Scientists from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, isolated and developed the antibody from a survivor of the 1995 Ebola outbreak in the Democratic Republic of the Congo (DRC), in collaboration with the Institut National de Recherche Biomedicale, the Institute for Research in Biomedicine, and the U.S. Army Research Institute of Infectious Diseases.
“Effective Ebola therapeutics are essential in saving lives not only in the current outbreak in the DRC but also in future outbreaks anywhere in the world and to discourage any potential use of this virus in bioterrorism,” said BARDA Director Rick Bright, Ph.D. “Combating this horrific disease requires every tool we can provide to healthcare providers and patients.”
Currently mAb114 is being offered to Ebola patients in the DRC under an expanded access protocol led by the World Health Organization and as part of an extension of a clinical trial called PALM or “Pamoja Tulinde Maisha,” which translates to “together save lives”. The trial is co-sponsored by NIAID and the National Biomedical Research Institute in the DRC, and is being carried out by an international consortium coordinated by the World Health Organization.
This product received FDA Breakthrough Therapy Designation, which helps facilitate development toward approval of critical medical products by allowing companies to submit parts of their application on a rolling basis and to work more closely with FDA officials throughout the review process.
The investigational treatment initially was manufactured in collaboration with the Defense Advanced Research Projects Agency and has been deployed to DRC as a powder that is reconstituted onsite at the Ebola Treatment Centers and as a liquid. This powder formulation does not require freezer storage, which has been helpful in the current outbreak region where freezer storage sometimes has been unreliable.
Clinical use of mAb114 within the current outbreak was the result of an extensive collaborative effort among HHS agencies, most prominently NIAID’s Vaccine Research Center and Division of Clinical Research, as well as with the Institut National de Recherche Biomedicale and the Ministry of Health in the DRC.
In addition to mAb114, BARDA is supporting advanced development of Ebola therapeutics under public-private partnerships with Regeneron Pharmaceuticals, Inc. and Mapp Biopharmaceutical, Inc. and is working with Merck and Janssen to develop Ebola vaccines. BARDA also directly supports the U.S. government’s response to the outbreak in the DRC.
According to the World Health Organization, in the year since the DRC declared the current Ebola virus outbreak, the country’s health ministry has confirmed more than 3,000 cases of Ebola virus disease and more than 2,000 deaths from the illness.