Ebola Treatment mAb114 Granted Fast Track Status
Ridgeback Biotherapeutics LP announced that the Food and Drug Administration (FDA) recently granted the mAb114 experimental treatment for Ebola, Breakthrough Therapy designation.
This announcement on September 6, 2019, says ‘Breakthrough Therapy designation was based on interim data from the Pamoja Tulinde Maisha (PALM) study.
“The substantial survival improvement seen with mAb114 in the PALM trial catalyzed this important regulatory milestone,” said Wendy Holman, CEO of Ridgeback Biotherapeutics, in this press release.
mAb114 is a monoclonal antibody, which is a protein that binds to a single target on a pathogen, isolated from a human survivor of the 1995 Ebola outbreak in the Democratic Republic of Congo (DRC).
"The FDA's decision to grant mAb114 Breakthrough Therapy designation for the treatment of Ebola reflects a recognition of the promising efficacy and safety data that has been collected to date for this investigational drug.”
This is important news since increased mortality among survivors of the Ebola virus disease compared with the general population is alarming.
The Ebola virus disease, also known as Ebola hemorrhagic fever, is a rare and deadly disease that periodically causes outbreaks in several African countries. The virus is spread by contact with blood or body fluids of a person infected with Ebola.
Previous mAb114 news
- Two Ebola Zaire Medications Offer Greater Chance of Survival
- Experimental Ebola Treatment Reported Safe
- Travel Alert Expanded for Ebola Outbreak in The Democratic Republic of Congo
The PALM study is co-sponsored and funded by the INRB (Institut National de Recherche Biomédicale) and the National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health and carried out by an international research consortium coordinated by the World Health Organization (WHO).
During January 2019, mAb114 was found safe, well-tolerated, and easy to administer, according to an early-stage clinical trial published in The Lancet.
Nancy Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID's Vaccine Research Center (VRC), and her team, in collaboration with researchers from the National Institute of Biomedical Research (INRB) in the DRC and the Institute for Research in Biomedicine and Vir Biotechnology, Inc.'s subsidiary Humabs BioMed, both based in Bellinzona, Switzerland, discovered that the survivor retained antibodies against Ebola 11 years after infection.
They isolated the antibodies and tested the most favorable ones in the laboratory and non-human primate studies, and selected mAb114 as the most promising.
Professor Jean-Jacques Muyembe, director general of INRB and one of the scientists involved in the original detection of the Ebola virus in 1976, played a key role in discovering mAb114.
Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.’
Ridgeback Biotherapeutics LP is a privately held, majority woman-owned biotechnology company focused on orphan and infectious diseases. To date, all funding for Ridgeback Biotherapeutics has originated from Wayne and Wendy Holman.
Published by Vax Before Travel
- Ridgeback Biotherapeutics LP announces receipt of Breakthrough Therapy designation from FDA for mAb114
- NIH: Investigational Monoclonal Antibody to Treat Ebola Is Safe in Adults
- Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus
- NIH: Clinical Trial of Investigational Ebola Treatments Begins in the Democratic Republic of the Congo
- Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy