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Ridgeback Biotherapeutics Breakthrough Therapy Designation for mAb114

September 10, 2019 By americanpharmaceuticalreview

Ridgeback Biotherapeutics announced the Food and Drug Administration (FDA) has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.

 Ebola

Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.  Breakthrough Therapy designation was based on interim data from the Pamoja Tulinde Maisha (PALM [together save lives]) study.

"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.  We plan to work closely with the FDA as we continue to advance our development program for mAb114.  The substantial survival improvement seen with mAb114 in the PALM trial catalyzed this important regulatory milestone.  We are grateful to our PALM partners for all of their help in advancing treatments for Ebola patients and our ultimate gratitude goes to the study's participants and their families.  Their trust and support will change the course of this disease," said Wendy Holman, CEO of Ridgeback Biotherapeutics.

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).  The Ebola treatment centers in the PALM trial have been overseen by staff from the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; and three medical humanitarian organizations:  the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médicins Sans Frontières (MSF).

mAb114 is a monoclonal antibody — a protein that binds to a single target on a pathogen — isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the DRC. 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.

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