YAbS







Roledumab Terminated Naked monospecific

Antibody Information

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

Therapeutic information

Target(s) Rhesus D
Indications of clinical studies Hemolytic disease of newborns, idiopathic thrombocytopenic purpura
Primary therapeutic area Cardiovascular / hemostasis disorders

Development stage information

Phase lengths*
*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).
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 information

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/

Description/comment

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.).

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None