Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 97 |
| INN | Ansuvimab |
| Status | Approved |
| Drug code(s) | mAb114, VRC-EBOMAB092-00-AB |
| Brand name | Ebanga |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Human B cell-derived |
| Target(s) | Ebola virus glycoprotein |
| Indications of clinical studies | Ebola infection |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 25, 2018 |
| Start of Phase 2 | |
| Start of Phase 3 | November 20, 2018 |
| Date BLA/NDA submitted to FDA | May 29, 2020 |
| Year of first approval (global) | 2020 |
| Date of first US approval | December 21, 2020 |
| INN, US product name | Ansuvimab, Ansuvimab-zykl |
| US or EU approved indications | Treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children |
| Company | Ridgeback Biotherapeutics |
| Licensee/Partner | None |
| Comments about company or candidate | On July 29, 2020, Ridgeback Biotherapeutics LP announced FDA has accepted the BLA and granted priority review designation for Ridgeback’s investigational Ebola treatment, ansuvimab (mAb114). Sep 2019: MAb114 granted Breakthrough Therapy designation. Aug 2019: Pamoja Tulinde Maisha (PALM [together save lives]) study announced early termination of the four-arm study and changes in treatment for patients with Ebola. The preliminary results in 499 study participants indicated that those individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to those participants in the other two arms. The PALM study is 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. As of August 9, 2019, the trial had enrolled 681 patients toward an enrollment goal of 725. NCT03719586 Phase 2/3 study started in Nov 2018. Dec. 13, 2018: Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that it has entered into a patent license agreement with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health, for intellectual property related to the monoclonal antibody mAb114, an experimental treatment for Ebola. mAb114 has completed a Phase 1 safety study and is currently being administered to some Ebola patients in the Democratic Republic of Congo under two separate protocols. mAb114 was 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 Biomedical Research in 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. US orphan designation IND 138090 was submitted on January 25, 2018 by the National Institute of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), to study VRC-EBOMAB092-00-AB (mAb114) referred to as ansuvimab-zykl, for the indication of treatment of Zaire ebolavirus (EBOV) infection [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761172Orig1s000IntegratedR.pdf] |
| Full address of company | 3480 Main Highway, Miami, FL 33133 North America United States of America https://ridgebackbio.com/contact/ |
mAb114 is a human IgG1 antibody that binds to a highly conserved region of amino acids in the receptor-binding domain of EBOV variants and prevents the interaction of the glycoprotein with the NPC1 receptor, thus blocking virus entry into the cytoplasm of the host cell. mAb114 has several advantageous properties that allow it to remain functional during many steps of the viral lifecycle, including remaining bound to the receptor-binding domain in both physiological and low pH intracellular environments and after glycoprotein cathepsin cleavage events. (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30036-4/fulltext)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |