YL201 Clinical ADC

Antibody Information

Entry ID	1480
INN	None
Status	Clinical
Drug code(s)	YL201
Brand name	None
mAb sequence source	mAb human
General Molecular Category	ADC
Format, general category	TBD
Format details	TBD
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	Tumor Microenviroment Activable Linker
Ave. DAR	___
Conjugated/fused moiety	Topoisomerase I inhibitor, YL0010014
Discovery method/technology	None

Therapeutic information

Target(s)	B7-H3
Indications of clinical studies	Nasopharyngeal Carcinoma, Small cell lung cancer, 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)	March 15, 2022
Start of Phase 2	September 15, 2023
Start of Phase 3	December 17, 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	MediLink Therapeutics (Suzhou) Co. Ltd.
Licensee/Partner	None
Comments about company or candidate	NCT06629597 Phase 3 in Nasopharyngeal Carcinoma due to start in Dec 2024. NCT06612151 Phase 3 in small cell lung cancer due to start in Dec 2024. NCT06241846 Phase 2 in prostate cancer started in Feb 2024. NCT06057922 Phase 1/2 started in Sep 2023. September 23, 2023: oncologists and experts from more than 60 clinical research centers across the country gathered in Guangzhou to participate in the YL201 Phase I/II Investigators Meeting hosted by Suzhou MediLink Therapeutics Co., Ltd. NCT05434234 Phase 1 study started on June 9 2022. April 12, 2022: MediLink Therapeutics announced that YL201, the first compound based on MediLink's proprietary antibody-drug conjugate (ADC) technology platform, has been cleared on its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its Phase I first-in-human study. Preclinical data demonstrated great efficacy of YL201 in various in vivo tumor models, such as non-small cell lung cancer, prostate cancer and esophageal squamous cell carcinoma.
Full address of company	Room 2201, Tai Chao, Block A, Honghui International Plaza, No. 1600-1602, West Zhongshan Road, Xuhui District, Shanghai Asia China https://www.medilinkthera.com/contact#ny-nav

Description/comment

YL201 uses a novel "TMALIN" (Tumor Microenviroment Activable Linker) ADC technology developed at MediLink Therapeutics to resolve potential ADC resistance and stability issues. Drug is topoisomerase I inhibitor YL0010014

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None