Ridgeback Biotherapeutics Announces FDA Breakthrough Therapy Designation for mAb114 in Ebola Treatment

On September 11, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that biopharmaceutical company Ridgeback Biotherapeutics (Ridgeback) announced that its drug mAb114 had received FDA Breakthrough Therapy Designation for the treatment of Ebola virus.

Breakthrough Therapy designation is intended to accelerate the development and review of new drugs for treating serious conditions. The criteria for Breakthrough Therapy designation require preliminary clinical evidence demonstrating that the drug offers a substantial improvement over existing therapies. The Breakthrough Therapy designation was based on data from the Pamoja Tulinde Maisha (PALM) study.

PALM is jointly funded by the Institut National de Recherche Biomédicale (INRB) and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health. The PALM Ebola Treatment Center is jointly funded by the Institut National de Recherche Biomédicale (INRB), the Ministry of Health of the Democratic Republic of the Congo, the Alliance for International Medical Action (ALIMA), International Medical Corps (IMC), and Médecins Sans Frontières (MSF).

Ridgeback is a biotechnology company headquartered in Miami, Florida, focused on researching innovative therapies for infectious diseases. The company’s CEO and co-founder is Wendy Commins Holman. Prior to founding Ridgeback in 2015, Holman served as Principal at Ziff Brothers Investments and Head of Research at ZBI Equities, a multi-billion-dollar public equity investment fund. The Ridgeback team is dedicated to finding life-saving and life-changing solutions for patients.

mAb114 is a monoclonal antibody isolated from a survivor of the 1995 Ebola outbreak in Kikwit, Democratic Republic of the Congo. Through a collaborative effort involving the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), the Institut National de Recherche Biomédicale (INRB), the Biomedical Research Institute of the Democratic Republic of the Congo, and Humabs BioMed, mAb114 was identified as the most promising antibody in non-human primate studies. Professor Jean-Jacques Muyembe, Director General of INRB and one of the scientists who first discovered the Ebola virus in 1976, played a pivotal role in the discovery of mAb114.

Wendy Commins Holman stated, “The U.S. Food and Drug Administration’s (FDA) decision to grant Breakthrough Therapy designation to mAb114 for the treatment of Ebola virus reflects recognition of the drug’s efficacy and safety. We plan to work closely with the FDA, and Ridgeback will continue to advance the development program for mAb114. In the PALM trial, mAb114 demonstrated favorable therapeutic effects, and the Breakthrough Therapy designation marks a milestone in the drug’s development. Ridgeback is deeply grateful to the PALM trial partners for their assistance in advancing treatments for Ebola patients, as well as to the study participants and their families, whose trust and support will transform the trajectory of therapeutic development for this disease.”

(Compiled by Hu Yifan)