Ebanga (mAb114) Antibody Description
Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga (mAb114) is a human IgG1 MAb targeted to the Zaire ebolavirus (EBOV) glycoprotein, available in a lyophilized form.
The US Food and Drug Administration (FDA) issued authorization for Ebanga on December 21, 2020.
Ebanga (mAb114) is a single monoclonal antibody that binds to the Zaire ebolavirus surface protein's core receptor binding domain, preventing the virus from infecting human cells. It was isolated from the blood of a survivor of the 1995 Ebola virus disease outbreak in the Democratic Republic of Congo.
The Vaccine Research Center developed Ebanga (mAb114) with support from the U.S. NIH and the Defense Advanced Projects Agency.
Wendy Holman, CEO and co-founder of Ridgeback said in a press statement issued on December 22, 2020: 'the true heroes are the patients and their families who allowed themselves to be carried away from their homes – not knowing if they would ever return – to enroll in a randomized controlled trial at the Ebola treatment centers during the 2018-2020 Ebola outbreak in the DRC. Your trust and belief in science, innovation, and the people caring for you have transformed Ebola forever. Thanks to you, Ebola is now a treatable disease.'
Ridgeback will continue to make Ebanga available to patients who need it. In 2020, Ridgeback initiated a compassionate use protocol for Ebola patients during the DRC’s 11th Ebola outbreak in Équateur Province. Ebanga was provided to all PCR-positive Ebola patients under this protocol.
Dr. Sabue Mulangu, Senior Vice President of Global Affairs at Ridgeback, commented: “We were hopeful that news of an effective treatment would encourage patients with Ebola symptoms to present early in the disease course, which should lead to even better outcomes for patients and less spread in the community. We are looking forward to publishing the tremendous results of this effort in Équateur Province. In addition, we are working with at-risk African nations and non-government agencies to preposition Ebanga and ensure access for patients.”
Ridgeback Biotherapeutics LP obtained a license for mAb114 in 2018 from the U.S. NIH.
Ebanga (mAb114) Antibody Indication
Ebanga is indicated to protect from the Ebola virus. mAb114 has been shown success with lowering the mortality rate from ~70% to about 34%.
Ebanga (mAb114) Antibody Dosage
Ebanga is administered by IV infusion at dosages of 5, 25, and 50 mg/kg in the clinical trial. Ebanga is available in a lyophilized form.
Ebanga (mAb114) Antibody Therapy Updates
December 22, 2020 - Ridgeback Biotherapeutics LP announced today that the U.S. Food and Drug Administration approved Ebanga to treat Ebola. Ebanga is now approved to treat infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. The efforts of the Pamoja Tulinde Maisha (PALM [“Together Save Lives” in the Kiswahili language]) study team conclusively demonstrated Ebanga’s safety and efficacy in a randomized controlled trial conducted during the 2nd largest and longest outbreak in DRC history. The PALM study team efforts represent a landmark achievement in developing medical countermeasures for emerging infectious diseases.
December 21, 2020 - The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for Zaire's treatment ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks the binding of the virus to the cell receptor, preventing its entry into the cell.
August 28, 2020 - Ridgeback Biotherapeutics LP. announced the implementation of an expanded access protocol to ensure rapid access to its promising Ebola treatment, ansuvimab, in the Democratic Republic of the Congo (DRC). The Institut National de Recherche Biomédicale of the DRC is conducting this open-label expanded access clinical trial initiated earlier this month. Ridgeback is providing study drug and operational support for this trial.
December 12, 2019 - Editorial: Monoclonal Antibody Therapy for Ebola Virus Disease.
September 6, 2019: Ridgeback Biotherapeutics LP announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.
August 13, 2019: The first-ever multi-drug randomized control trial to evaluate Ebola Zaire therapeutic medications' safety and efficacy reported 2 experimental products would continue to be studied. The Pamoja Tulinde Maisha study’s investigational agents were ZMapp, remdesivir, mAb114, and REGN-EB3. Additionally, this DSMD said, ‘all future study participants should be randomized to receive either the REGN-EB3 or mAb114 medications.’
December 13, 2018 - Ridgeback Biotherapeutics LP announced that it has entered into a patent license agreement with the NIH for intellectual property related to the monoclonal antibody mAb114, an experimental treatment for Ebola.
Ebanga (mAb114) Antibody Clinical Trials
Clinical Trial NCT03719586: Investigational Therapeutics for the Treatment of People With Ebola Virus Disease.
Clinical Trial NCT03478891: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adult.