Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 117 |
| INN | Docaravimab, Miromavimab |
| Status | Approved |
| Drug code(s) | Rabimabs |
| Brand name | Twinrab |
| mAb sequence source | mAb murine |
| General Molecular Category | Mixture of 2 |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2b |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Mouse origin |
| Target(s) | Rabies virus (glycoprotein) |
| Indications of clinical studies | Rabies (post-exposure) |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved India |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2012 |
| Start of Phase 2 | |
| Start of Phase 3 | August 01, 2017 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2019 |
| Date of first US approval | |
| INN, US product name | Rabimabs |
| US or EU approved indications | None |
| Company | Zydus Research Center, Cadila Healthcare Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | Phase 1 and Phase 1/2 studies in healthy volunteers conducted in India. Phase III protocol approved by DCGI - “Randomized, Multi-centric, Open-label, Comparator-controlled study to evaluate the efficacy and safety of RabiMabs administered in conjunction with Vaxirab N for Post-exposure prophylaxis in patients following potential rabies exposure” (CTRI/2017/07/009038). May 2019: FDA grants orphan drug desination for anti-rabies monoclonal antibody in Rabies |
| Full address of company | Zydus Research Centre Sarkhej-Bavla N.H. No. 8A Moraiya, Ahmedabad – 382210 Gujarat, India Asia India https://zyduslife.com/research |
Cocktail of 2 anti-rabies monoclonal antibodies being developed at Zydus Research Center, Cadila Healthcare Ltd. is a unique combination of two murine anti-G monoclonal antibodies (MAbs) selected from a panel of five MAbs shortlisted by WHO from collaborating research centres around the world, that bind to two different epitopes on the G protein expressed on the surface of Rabies virus. From panels of anti-rabies Mabs available through its collaborating centers, WHO had initially selected a smaller panel of five murine anti-G MAbs on the basis of their ability to neutralise a broad range of rabies viruses and their heavy chain isotype, selected to be either IgG1 or IgG2a. From this shortlisted panel of WHO, Zydus selected two monoclonals primarily on the basis of their ability to bind two different epitopes on the G protein, and secondarily on the basis of the phenotypic stability of the clone, ability to grow in bioreactors, ability for scalability of the clone, expression levels of the clone etc. M777-16-3 (IgG1) - Binds to site II on G protein of rabies virus envelope; 62-71-3 (IgG2b) - Binds to site III on G protein of rabies virus envelope. Equipotent mix of 2 monoclonals; Hybridoma production.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |