Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 580 |
| INN | Ifinatamab deruxtecan |
| Status | Clinical |
| Drug code(s) | DS-7300a |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Glycine-Glycine-Phenylalanine-Glycine (GGFG; Tetrapeptide-based cleavable linker) |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Topoisomerase I inhibitor, DXd/DX-8951 (MAAA-1181a) |
| Discovery method/technology | None |
| Target(s) | B7-H3 |
| Indications of clinical studies | Esophageal Squamous Cell Carcinoma, Small cell lung cancer, 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) | October 17, 2019 |
| Start of Phase 2 | June 15, 2022 |
| Start of Phase 3 | May 15, 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 | Daiichi Sankyo Co. Ltd |
| Licensee/Partner | Merck Sharp & Dohme |
| Comments about company or candidate | Listed as Phase 3 in Merck pipeline dated Nov 1 2024. Phase 3 study for Esophageal Squamous Cell Carcinoma (NCT06644781) due to start in February 2025 NCT06203210 Phase 3 study in SCLC started in May 2024. October 19, 2023 I Daiichi Sankyo and Merck have entered into a global development and commercialization agreement for three of Daiichi Sankyo’s DXd antibody drug conjugate (ADC) candidates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd). NCT05280470 Phase 2 in small cell lung cancer started in June 2022 recruiting as of last update in Mar 2023. NCT04145622 Phase 1/2 in solid tumors started in Oct 2019; still recruiting as of last update in Feb 2023. |
| Full address of company | Chuo City, Tokyo, Japan Asia Japan https://www.daiichisankyo.com/ |
Immune checkpoint target. DAR=4. DS-7300a is a B7-H3-targeting antibody-drug conjugate (ADC), which is composed of a humanized anti-B7-H3 monoclonal antibody (MABX-9001a), an enzymatically cleavable peptide-based linker, and a novel exatecan derivative (DXd) that is a potent DNA topoisomerase I inhibitor. https://www.ejcancer.com/article/S0959-8049(20)31102-3/fulltext
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |