Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | HER2, HER2 |
| Indications of clinical studies | HER2+ breast and gastric cancers |
| Primary therapeutic area | Cancer |
| 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 | 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 |
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.)
| Anticipated events | BLA in 2025 planned |
| Factor(s) contributing to discontinuation | None |