Anbenitamab Clinical Bispecific, Biparatopic

Antibody Information

Entry ID	895
INN	Anbenitamab
Status	Clinical
Drug code(s)	KN026
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Bispecific, Biparatopic
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)	HER2, HER2
Indications of clinical studies	HER2+ breast and gastric cancers
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)	September 17, 2018
Start of Phase 2	June 17, 2019
Start of Phase 3	April 07, 2022
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 Alphamab Biopharmaceuticals Co. Ltd
Licensee/Partner	Sanofi
Comments about company or candidate	June 30, 2024: The NDA for KN046 is expected to be determined whether to be submitted in 2024, subject to the results of its final OS analysis for first-line treatment of sq NSCLC, and the one for KN026 is expected to be submitted in 2025. (https://www.alphamabonc.com/en/uploads/2024/08/172372714522178.pdf) July 28 2023 press release: First patient has been successfully dosed in a randomized, controlled, open-label, multi-center, phase III clinical trial of KN026 in China NCT05838066 Phase 3 due to start in July 2023. NCT05427383 Phase 2/3 in Gastric/Gastroesophageal junction cancer (KN026-CSP-001) started in April 2022 recruiting as of last update in June 2022. KN026+KN046 combo in gastric cancer granted US Orphan Drug designation. NCT04521179 Phase 2 in solid tumors started in Dec 2020. NCT04165993 Phase 2 in metastatic breast cancer not yet recruiting when posted on Nov 22, 2019. NCT03925974 Phase 2 study in HER2+ Gastric/Gastroesophageal Junction cancer recruiting as of June 17, 2019. NCT03619681 Phase 1 study in HER2+ breast and gastric cancers started in Sep 2018
Full address of company	218 Xinhu St. Building #C23, Suzhou, Jiangsu Asia China https://www.alphamabonc.com/en/contact/index.html

Description/comment

KN026* is an anti-HER2 Fc-based heterodimer bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2. Derived from Charge Repulsion Induced Bispecific (CRIB) technology; heterodimeric Fc with K409A in knob chain and F405K mutation in the hole chain (Wei H, Cai H, Jin Y, et al. Structural basis of a novel heterodimeric Fc for bispecific antibody production. Oncotarget, 2017, 8(31): 51037.)

Additional information

Anticipated events	BLA in 2025 planned
Factor(s) contributing to discontinuation	None