Gumokimab Regulatory review Naked monospecific

Antibody Information

Entry ID	250
INN	Gumokimab
Status	Regulatory review
Drug code(s)	AK111
Brand name	(Pending)
mAb sequence source	mAb chimeric/humanized
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-17A
Indications of clinical studies	Psoriasis, ankylosing spondylitis
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)	Regulatory review China
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 01, 2019
Start of Phase 2	April 28, 2021
Start of Phase 3	March 15, 2023
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	Akesobio Australia Pty Ltd
Licensee/Partner	None
Comments about company or candidate	January 26, 2025 I Akeso, Inc. announced that the New Drug Application (NDA) of its internally-developed IL-17-targeting monoclonal antibody gumokimab (AK111) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. NCT06378697 Phase 3 in ankylosing spondylitis started in Nov 2023. CTR20230111 / NCT06066125 Phase-3 clinical trial in Plaque psoriasis (Treatment-resistant) in China (SC) started in April 2023. NCT05096364 Phase 2 in psoriasis started in April 2021. Phase 2 in Ankylosing Spondylitis started in June 2021. First patient with moderate-to-severe plaque psoriasis was dosed with AK111 in Phase Ib study in China (June 2020); Phase 1 as per company pipeline update dated Aus 2020. https://www.akesobio.com/media/1306/akeso-2020-interim-results-presentation.pdf In addition to psoriasis, we may potentially expand our evaluation of AK111 into additional indications such as ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA). We have completed a Phase I clinical trial of AK111 in New Zealand. We have also obtained an IND approval for psoriasis in China and plan to enroll patients in a Phase Ib trial in the first half of 2020. https://www1.hkexnews.hk/app/sehk/2020/101281/a103181/sehk20020303464.pdf
Full address of company	Address : 17/F, HWT Tower, No. 40, City Road Southbank, VIC 3006, Australia Australia Australia https://www.akesobio.com/en/about-us/contact-us/

Description/comment

Target is IL-17A according to https://www.akesobio.com/en/media/akeso-news/20210929/

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None