Ebanga™ Ebola Monoclonal Antibody Clinical Trials, Dosage, Indication, Side Effects
Ebanga™ (mAb114, Ansuvimab-zykl) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody (mAb) indicated for treating infection in adults and children. Ebanga (mAb114) is available in a lyophilized form and is a single mAb 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). mAb are proteins produced in a lab or other manufacturing facility that act like natural antibodies to stop a germ, such as a virus, from replicating after it has infected a person. These particular mAb binds to a portion of the Ebola virus's surface called the glycoprotein, which prevents the virus from entering a person's cells. This area of the Ebola glycoprotein, receptor binding domain (RBD), was previously thought unreachable by antibodies because it is well-hidden by other parts of the virus and only becomes exposed after it enters the inside cells.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID) and Dartmouth College researchers studied how Ebangneutralizedes the EBOV and determined that it binds to the core of the Ebola glycoprotein, blocking its interaction with a receptor on human cells. 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). Ebanga was granted an FDA Orphan Drug and Breakthrough Therapy designation. The U.S. Food and Drug Administration (FDA) authorized Ebanga for intravenous injections on December 21, 2020.
On August 19, 2022, the World Health Organization (WHO) Guideline Development Group (GDG) made a Strong Recommendation for treatment with mAb114 for patients with real-time polymerase chain reaction (RT-PCR) confirmed EVD and for neonates of unconfirmed EVD status, seven days or younger, born to mothers with confirmed EVD. This new WHO living guideline is written to accompany the optimized supportive care (oSoC) for EVD standard operating procedures.
Emergent BioSolutions agreed with Ridgeback Biotherapeutics to expand the availability of Ebanga on July 7, 2022. Emergent is responsible for the manufacturing, sale, and distribution of Ebanga in the USA and Canada, and Ridgeback Bio serves as the global access partner for Ebanga. Ridgeback Biotherapeutics L.P. is located in Miami, FL. Ridgeback obtained a license for mAb114 from the U.S. NIH in 2018. DrugBank: DB16385; UNII: TG8IQ19NG2.
Ebanga Indication
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. Zaire ebolavirus is one of four Ebolavirus species that can cause a potentially fatal human disease. It is transmitted through blood, body fluids, and tissues of infected people or wild animals and surfaces and materials, such as bedding and clothing, contaminated with these fluids. The efficacy of Ebanga has not been established for other species of the Ebolavirus and Marburgvirus genera. And Zaire ebolavirus can change over time, and factors such as the emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use Ebanga.
Ebanga Dosage
Ebanga is administered by IV infusion of 5, 25, and 50 mgial. Ebanga is available in a lyophilized form. For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution.
Ebanga Side Effects and Interactions
Hypersensitivity reactions, including infusion-associated events, have been reported with Ebanga. These may include acute, life-threatening responses during and after the infusion. Discontinue the administration of EBANGA immediately and administer appropriate emergency care. And no vaccine interaction studies have been performed. Ebanga may reduce the efficacy of the live vaccine. The interval between the administration of Ebanga therapy and live vaccination should be in accordance with current vaccination guidelines.
BARADA Agreements
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). On September 12, 2024, Emergent announced that it was awarded a contract modification valued at $41.9 million for drug substance engineering and scale-up process validation, long-term stability, and commercial readiness to support its ongoing scale-up program for Ebanga. On July 31, 2023, Emergent announced that the BARDA awarded it a 10-year contract, valued at up to a maximum of $704 million, under contract number 75A50123C00037, for advanced development, manufacturing scale-up and procurement of Ebanga™.
Ebanga (mAb114) News
September 12, 2024 - Paul Williams, senior vice president of products business, Emergent, stated, “We look forward to progressing the program with the goal of supplying treatment courses to enable preparedness against the Ebola virus. We believe this important work demonstrates our position as a leader in providing critical medical countermeasures.”
July 31, 2023 - Dr. Kelly Warfield, senior vice president, science and development at Emergent, stated in a press release, "Ebola virus can emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, underscoring the importance of preparedness efforts against this public health threat."
March 8, 2023 - The journal Frontiers published an article: Ebanga™: The most recent FDA-approved drug for treating Ebola.
September 30, 2022 - AllAfrica published Ebola - What Are the Symptoms, How Does It Spread, and Where Did It Come From?
August 19, 2022 - The WHO published its first guideline for Ebola virus disease therapeutics, with strong new recommendations for monoclonal antibodies. WHO calls on the global community to increase access to these lifesaving medicines.
July 7, 2022 - Emergent BioSolutions Inc. confirmed 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 showed that the patient relapsed 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 L.P. of Miami, which licensed the antibody and manufacturing processes from NIAIOverhan 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 L.P. 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.
September 6, 2019: Ridgeback Biotherapeutics L.P. 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 L.P. announced that it has entered into a patent license agreement with the NIH for intellectual property related to the mAbs 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.
