Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2209 |
| INN | Roledumab |
| Status | Terminated |
| Drug code(s) | LFB-R593 |
| Brand name | Dmatria |
| 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) | Rhesus D |
| Indications of clinical studies | Hemolytic disease of newborns, idiopathic thrombocytopenic purpura |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2008 |
| Start of Phase 2 | |
| Start of Phase 3 | April 15, 2014 |
| 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 | LFB Group |
| Licensee/Partner | None |
| Comments about company or candidate | No development reported as of Aug 2019. No information found on the LFB Group website as of Aug 1, 2018. NCT02287896 Phase 2/3 study completed as of Sep 2017. Very little information available as of Feb 2014. Only the 2012 annual report is available, no pipeline listed on LFB Group web site. |
| Full address of company | Suite 104, Spirella Building, Bridge Road, Letchworth Garden City, SG6 4ET Europe United Kingdom https://www.groupe-lfb.com/en/the-group/the-lfb-group/ |
Low fucose; produced in YB2/0 cells. IgG1 human sequence that was specific for RhD antigen was derived from Epstein–Barr virus-transformed B cells obtained from an RhD− male donor who had been immunized previously with RhD+ RBCs. The corresponding cDNA was transfected into various cell lines and the antibody produced was tested in stringent in vitro binding and functional assays; this led to the selection of an YB2/0 cell clone producing an antibody that mediates strong FcγRIII-dependent ADCC in vitro (Siberil et al, 2006; Br J Haematol. 2008 Apr;141(1):109-19. doi: 10.1111/j.1365-2141.2008.06985.x.).
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |