Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2605 |
| INN | Cosfroviximab, larcaviximab, porgaviximab |
| Status | Terminated |
| Drug code(s) | Zmapp |
| Brand name | ZMapp |
| mAb sequence source | mAb chimeric |
| 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 | None |
| Target(s) | Ebola virus glycoprotein |
| Indications of clinical studies | Ebola infection |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | February 15, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | November 20, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Mapp Biopharmaceutical |
| Licensee/Partner | None |
| Comments about company or candidate | Terminated; company is continuing development of MBP134, which is a 2-antibody combination with pan-ebola efficacy in non-clinical studies. June 2021: No recent development reported. Considering 2 mAb products (REGN-EB3 or mAb114) are aleady approved for Ebola, and both of these had better clinical study results, it is not clear if the company will pursue further development. 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; listed as Phase 2 when first posted in Oct 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. Sep 29, 2017: Mapp Biopharmaceutical, Inc., announced today that it has been awarded a Project BioShield contract (HHSO100201700017C) of approximately $46 million by The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to advance ZMappTM to licensure by the Food and Drug Administration. IND filed with FDA for clinical studies to be started in Liberia. August 8, 2016: Mapp Biopharmaceutical, Inc. (Mapp Bio) announced it has received funding from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to offer an expanded access protocol (EAP) for ZMapp™ to the four countries that participated in the PREVAIL II trial. An expanded access protocol is a U.S. regulatory mechanism for making an unlicensed drug available for the treatment of a serious or life-threatening disease for which no approved therapeutic is available. The PREVAIL II trial – sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted in Liberia, Sierra Leone, Guinea and the United States – evaluated the efficacy of ZMapp™ in treating Ebola Virus Disease (EVD). While the trial did not ultimately enroll enough patients to produce definitive results, the drug was well-tolerated and showed promise in improving survival of patients with EVD |
| Full address of company | 4921 Directors Pl #100, San Diego, CA 92121, USA North America United States of America https://mappbio.com/contact-us/ |
Mixture of 3 antibodies (https://pubmed.ncbi.nlm.nih.gov/27279622/)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |