Zalutumumab Terminated Naked monospecific

Antibody Information

Entry ID	2126
INN	Zalutumumab
Status	Terminated
Drug code(s)	HuMAX-EGFR, mAb 2F8
Brand name	None
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	Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform)

Therapeutic information

Target(s)	EGFR
Indications of clinical studies	Head and neck cancer, non-small cell lung cancer, colorectal cancer
Primary therapeutic area	Cancer

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)	June 27, 2003
Start of Phase 2
Start of Phase 3	September 15, 2006
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

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None

Company	Genmab
Licensee/Partner	None
Comments about company or candidate	Fast track
Full address of company	Copenhagen, Denmark Europe Denmark https://www.genmab.com/