Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 126 |
| INN | Atoltivimab, odesivimab, Maftivimab |
| Status | Approved |
| Drug code(s) | REGNEB3, REGN3470-3471-3479 |
| Brand name | Inmazeb |
| mAb sequence source | mAb human |
| General Molecular Category | Mixture of 3 |
| 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 | Transgenic mouse (VelocImmune) |
| 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) | May 15, 2016 |
| Start of Phase 2 | |
| Start of Phase 3 | November 20, 2018 |
| Date BLA/NDA submitted to FDA | October 02, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | October 14, 2020 |
| INN, US product name | Odesivimab, Maftivimab, atoltivimab; atoltivimab, maftivimab, and odesivimab-ebgn |
| US or EU approved indications | Treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | April 16, 2020: Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a new Biologics License Application (BLA) for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. PDUFA date is October 25, 2020. Nov 2019: Breakthrough Therapy designation granted and rolling BLA initiated. Rolling review was granted on October 2, 2019; final submission Feb 25, 2020. [https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761169Orig1s000MultidisciplineR.pdf] 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. Listed as Phase 3 in Regeneron pipeline update June 2019. NCT03719586 Phase 2/3 study started in Nov 2018. Nov 2018: An international research team has begun patient enrollment in a clinical trial testing multiple investigational Ebola therapies in the Democratic Republic of the Congo (DRC). The randomized, controlled trial is enrolling patients of any age with confirmed Ebola virus disease (EVD) at a treatment unit in the city of Beni The trial aims to compare mortality among patients who receive one of three investigational Ebola drugs with a control group of patients who receive the investigational monoclonal antibody cocktail treatment ZMapp, developed by Mapp Biopharmaceutical, Inc. The therapies being tested include: mAb114, a single monoclonal antibody developed by NIAID, with early support from the INRB; and remdesivir (also known as GS-5734), an antiviral drug developed by Gilead Sciences, Inc. The trial has been approved to begin enrolling patients in these three groups, and plans are underway to amend the trial to include REGN-EB3 (also known as REGN3470-3471-3479), a monoclonal antibody cocktail developed by Regeneron Pharmaceuticals, Inc. Still listed in Regeneron pipeline as of July 2018. May 2018: Regeneron Pharmaceuticals, Inc. announced that REGN-EB3 (also known as REGN3470-34713479), its investigational therapy that combines three fully-human monoclonal antibodies, is being shipped to the Democratic Republic of the Congo for use in the current Ebola virus infection outbreak. NCT02777151 Phase 1 completed. US orphan designation for Ebola infection |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
Combination of 3 antibodies to Ebola virus. Pascal KE et al. The Journal of Infectious Diseases, jiy285, https://doi.org/10.1093/infdis/jiy285
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |