Ridgeback Biotherapeutics LP Announces Orphan Drug Designation for mAb114
MIAMI, May 30, 2019 /PRNewswire/ -- Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Orphan Drug Designation.
mAb114 has completed a Phase 1 safety study and is currently being used to treat Ebola patients in the Democratic Republic of Congo under two separate protocols. The first is a randomized controlled trial in which mAb114 and other Ebola therapeutics will be evaluated for efficacy and safety in the treatment of Ebola patients. This trial is coordinated by the World Health Organization, and led and sponsored by the DRC's National Institute for Biomedical Research (INRB) in partnership with the DRC Ministry of Health, the United States National Institute for Allergy and Infectious Diseases (NIAID), The Alliance for International Medical Action (ALIMA) and other organizations. The second is an expanded access program in which mAb114 is given in-line with the WHO ethical framework known as Monitored Emergency Use of Unregistered Interventions (MEURI), which allows for access to investigational therapeutics outside of clinical trials. In preclinical studies, mAb114 has shown protection against Ebola in non-human primates with only one dose of treatment.
"We are pleased to receive orphan drug designation for mAb114 which has shown the potential to address an area of high unmet medical need. This is an important regulatory milestone for Ridgeback as we continue to focus on meeting the needs of the infectious disease and rare disease community," said Wendy Holman, CEO and co-founder of Ridgeback Biotherapeutics LP. "We believe that mAb114 has great potential in the treatment of Ebola Virus Disease and we are actively advancing the development of mAb114. Powerful Ebola treatments are an essential tool for containing this very difficult disease which knows no borders. Our partners at NIAID's Vaccine Research Center have done an incredible job supplying mAb114 during the current Ebola outbreak in the Democratic Republic of the Congo. We have completed the manufacturing technology transfer process and have begun manufacturing mAb114 at a commercial manufacturing facility. We hope to soon assist our partners in supplying mAb114 to patients in need."
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.
About Ridgeback Biotherapeutics LP:
Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held biotechnology company focused on orphan and infectious diseases. The team at Ridgeback is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions.
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SOURCE Ridgeback Biotherapeutics LP