Ebanga™ Ebola Antibody
Ebanga™ (Ansuvimab-zykl) is a human monoclonal antibody (mAbs) for treating Zaire 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. Ebanga 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 (EVD) outbreak in the Democratic Republic of Congo (DRC).
The U.S. Vaccine Research Center developed Ebanga (mAb114) with support from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract Numbers 75A50119C00059 and 75A50120C00009. Ridgeback obtained a license for mAb114 from the U.S. NIH in 2018. The U.S. Food and Drug Administration (FDA) issued authorization for Ebanga on December 21, 2020.
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 Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries.
Ridgeback Biotherapeutics LP is located in Miami, FL. DrugBank: DB16385; UNII: TG8IQ19NG2.
EBANGA is indicated for treating 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. In addition, Ebanga is indicated to protect from the Ebola virus.
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 News 2018 - 2022
July 7, 2022 - Emergent BioSolutions Inc. issued a press release confirming an agreement with Ridgeback Biotherapeutics to expand the availability of Ebanga™.
April 1, 2021 - The NEJM Journal reported during the 2018–2020 Ebola virus disease (EVD) outbreak in North Kivu province in the Democratic Republic of Congo, EVD was diagnosed in a patient who had received the recombinant vesicular stomatitis virus-based vaccine expressing a ZEBOV glycoprotein (rVSV-ZEBOV) (Merck). His treatment included an Ebola virus (EBOV)–specific monoclonal antibody (mAb114), and he recovered within 14 days. However, six months later, he presented again with severe EVD-like illness and EBOV viremia and died. Epidemiologic and genomic investigations were initiated that showed that the patient had had a relapse of acute EVD, leading to a transmission chain resulting in 91 cases across six health zones over four months.
February 2, 2021 - The antibody, mAb114 or ansuvimab, is marketed as Ebanga by Ridgeback Therapeutics LP of Miami, which licensed the antibody and manufacturing processes from NIAID. More than 10,000 drug product vials were manufactured by the Frederick National Laboratory's Vaccine Clinical Materials Program in 2018 for clinical trials in the Democratic Republic of Congo.
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's 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 of 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 two experimental products that 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
The Pamoja Tulinde Maisha (PALM [together save lives]) study was a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114, and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018, in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces. EBANGA lowered the risk of dying from the infection. Out of 174 patients treated with EBANGA, 61 patients (35%) died within 28-days in comparison to 83 out of the 168 patients (49%) who were treated with another experimental drug.