Tabalumab Terminated Naked monospecific

Antibody Information

Entry ID	2221
INN	Tabalumab
Status	Terminated
Drug code(s)	LY-2127399
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Transgenic mouse

Therapeutic information

Target(s)	BAFF
Indications of clinical studies	Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Myeloma, Multiple Sclerosis, Kidney Failure, Chronic
Primary therapeutic area	Immune-mediated / inflammatory 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 3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	January 01, 2004
Start of Phase 2	March 15, 2006
Start of Phase 3	December 15, 2010
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	Eli Lilly and Company
Licensee/Partner	None
Comments about company or candidate	Studies in RA terminated in 2013; studies in lupus terminated in Oct 2014. Phase 1 study results published in Br J Clin Pharmacol. 2016 May; 81(5): 908–917. The initial phase 1 study of tabalumab included patients both with RA and SLE, as it was felt that tabalumab could be effective in both populations. Date of first phase 1 estimated.
Full address of company	Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us

Description/comment

B-cell activating factor (BAFF) is also known as tumor necrosis factor ligand superfamily member 13B and B cell activating factor (aka BLyS)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None