ASKB589 Clinical Naked monospecific

Antibody Information

Entry ID	325
INN	None
Status	Clinical
Drug code(s)	ASKB589
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Rabbit B cell derived

Therapeutic information

Target(s)	Claudin-18.2
Indications of clinical studies	Solid tumors
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)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 15, 2020
Start of Phase 2	January 18, 2021
Start of Phase 3	January 25, 2024
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	Jiangsu Aosaikang Pharmaceutical Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	NCT06206733 / CTR20233416 Phase 3 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced, and Unresectable G/GEJ Cancer started in Jan 2024. NCT05632939 Phase 1/2 study due to start in Dec 2022. NCT04632108 Phase 1/2 study in solid tumors. On April 13, 2020, Aosaikang Pharmaceutical announced that the clinical application of ASKB589 was accepted by NMPA.
Full address of company	Jiangsu, China Asia China https://www.ask-pharm.com/en/inside/50/76.html

Description/comment

ASKB589 is a humanized rabbit antibody targeting Claudin 18.2. https://ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.397

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None