Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 113 |
| INN | Ormutivimab |
| Status | Approved |
| Drug code(s) | NM57 |
| Brand name | None |
| 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 | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Rabies virus (glycoprotein) |
| Indications of clinical studies | Rabies (post-exposure) |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved China |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 01, 2009 |
| Start of Phase 2 | |
| Start of Phase 3 | July 01, 2018 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2022 |
| Date of first US approval | |
| INN, US product name | Ormutivimab |
| US or EU approved indications | Post-exposure prophylaxis of rabies |
| Company | Molecular Targeting Technologies Inc |
| Licensee/Partner | North China Pharmaceutical Group Corp, Janssen |
| Comments about company or candidate | Jan 2022: Molecular Targeting Technologies, Inc., announced that the Chinese NMPA has approved a rabies virus neutralizing, fully human antibody, Ormutivimab for post-exposure prophylaxis. Clinical results showed Ormutivimab to be safe and effective, achieving its main and secondary efficacy endpoints after a single injection in exposed individuals. Ormutivimab was invented at Thomas Jefferson University and licensed to MTTI which has conducted trials in China in partnership with the North China Pharmaceutical Co., Ltd (NCPC). https://www.businesswire.com/news/home/20220126005104/en/Molecular-Targeting-Technologies-Inc.-Thomas-Jefferson-University-and-North-China-Pharmaceutical-Co.-Ltd-Announced-the-Chinese-Approval-for-a-Rabies-Drug Preregistration for Rabies in China (IM) (Molecular Targeting Technologies pipeline, March 2021), according to Adis Insight. Sep 2019: No additional information found. Listed on MTT website as Phase 3 (accessed Nov 2018). As of info on MTT website accessed Aug 2018, they completed IIa clinical trial (rhRIG and HRIG comparison test, 60 patients) and IIb trials (rhRIG and vaccine combined with vaccines and HRIG and combined with the comparison test, 200 patients). North China Pharmaceutical Company (NCPC) is initiating the phase III clinical trial in China in 2018. September 18, 2003: Molecular Targeting Technologies, Inc. announced today it has signed an agreement with the North China Pharmaceutical Group Corporation (NCPC) to develop a human anti-rabies monoclonal antibody product in China for post-exposure treatment of rabies. NCPC has optimized the cell lines and processes for production of clinical material. NCPC submitted a dossier to the Chinese FDA in 2007 for the conduct of clinical trials. They have completed a phase Ia safety and pharmacokinetic study in 40 subjects dosing at 10, 20, and 40 IU/kg and a subsequent phase Ib study. As per MMTI web page accessed August 2013, candidate is in Phase 1b by NCPG. As per MMTI web page accessed April 2017, NCPG is currently conducting a phase II clinical study. MTTI licensed from the Thomas Jefferson University and shares co-exclusive rights in China with Johnson & Johnson (previously Crucell) |
| Full address of company | 833 Lincoln Ave., Unit 9, West Chester, PA 19380 North America United States of America https://www.mtarget.com/CTUS.html |
immunoglobulin G1-lambda2, anti-[rabies lyssavirus (rabies virus, RABV) surface glycoprotein 4 (gp4) epitope I], Homo sapiens monoclonal antibody; gamma1 heavy chain Homo sapiens. produced in a Chinese hamster ovary (CHO)-K1 cell line, glycoform alfa
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |