Telikibart Clinical Naked monospecific

Antibody Information

Entry ID	675
INN	Telikibart
Status	Clinical
Drug code(s)	GR1802, GR-1802
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	None

Therapeutic information

Target(s)	IL-4R alpha
Indications of clinical studies	Allergic rhinitis, asthma, chronic urticaria, rhinosinusitis, atopic dermatitis
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)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 21, 2021
Start of Phase 2	July 01, 2022
Start of Phase 3	January 15, 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	Genrix (Shanghai) Biopharmaceutical Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	Phase 3 study in Chronic Rhinosinusitis With Nasal Polyps (NCT06516302) started in September 2024 NCT06216392 / CTR20233857 Phase 3 in Atopic Dermatitis started in Jan 2024. NCT05873803 Phase 2 in Chronic Rhinosinusitis With Nasal Polyps started in Feb 2023. CTR20212483 Phase 1b/II started in Nov 2021. CTR20211101 Phase 1 started in May 2021.
Full address of company	Shanghai, China Asia China http://www.genrixbio.com/

Description/comment

immunoglobulin G1-kappa, anti-[Homo sapiens IL4R (interleukin 4 receptor, IL4RA, IL-4RA, interleukin 13 receptor, CD124)], Homo sapiens monoclonal antibody;

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None