YAbS







Actoxumab, bezlotoxumab Terminated Mixture of 2

Antibody Information

Entry ID 2311
INN Actoxumab, bezlotoxumab
Status Terminated
Drug code(s) MK-3415A
Brand name None
mAb sequence source mAb human
General Molecular Category Mixture of 2
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 Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform)

Therapeutic information

Target(s) C. difficile (enterotoxin A and B)
Indications of clinical studies Clostridium difficile infection
Primary therapeutic area Infectious diseases

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 3
Status Inactive
Start of clinical phase (IND filing or first Phase 1) December 15, 2005
Start of Phase 2
Start of Phase 3 October 15, 2011
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 Bristol Myers Squibb
Licensee/Partner Merck
Comments about company or candidate Phase 3 studies of monotherapy or bezlotoxumab+actoxumab demonstrated that the combination did not provide added efficacy over bezlotoxumab alone
Full address of company New York, United States
North America
United States of America
https://www.bms.com/in

Description/comment

Mixture with MK-6072 (aka MDX-066, actoxumab, IgG1 kappa); bezlotoxumab = MDX-1388. MK-3415A (combination of mAb to toxin B, MDX-1388, and mAb to toxin A, MK-6072/MDX066/GS-CDA1)

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None