Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 325 |
| INN | None |
| Status | Clinical |
| Drug code(s) | ASKB589 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rabbit B cell derived |
| Target(s) | Claudin-18.2 |
| Indications of clinical studies | Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2020 |
| Start of Phase 2 | January 18, 2021 |
| Start of Phase 3 | January 25, 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 | Jiangsu Aosaikang Pharmaceutical Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06206733 / CTR20233416 Phase 3 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced, and Unresectable G/GEJ Cancer started in Jan 2024. NCT05632939 Phase 1/2 study due to start in Dec 2022. NCT04632108 Phase 1/2 study in solid tumors. On April 13, 2020, Aosaikang Pharmaceutical announced that the clinical application of ASKB589 was accepted by NMPA. |
| Full address of company | Jiangsu, China Asia China https://www.ask-pharm.com/en/inside/50/76.html |
ASKB589 is a humanized rabbit antibody targeting Claudin 18.2. https://ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.397
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |