Entry ID | 577 |
INN | Raludotatug deruxtecan |
Status | Clinical |
Drug code(s) | DS-6000A |
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; Cleavable linker) |
Ave. DAR | ~8 (Site-specific) |
Conjugated/fused moiety | Topoisomerase I inhibitor, DXd/DX-8951 (MAAA-1181a) |
Discovery method/technology | None |
Target(s) | Cadherin-6 |
Indications of clinical studies | Ovarian cancer, Phase 1 in Renal Cell Carcinoma and Ovarian Tumors |
Primary therapeutic area | Cancer |
Most advanced stage of development (global) | Phase 2/3 |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | January 15, 2021 |
Start of Phase 2 | |
Start of Phase 3 | March 27, 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 |
Comments about company or candidate | NCT06161025 Phase 2/3 in ovarian cancer started in Feb 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). NCT04707248 Phase 1 started in Jan 2021 still recruiting as of May 20, 2022. |
Full address of company | Chuo City, Tokyo, Japan Asia Japan https://www.daiichisankyo.com/ |
Target is cadherin 6; DAR = 8 (https://www.daiichisankyo.com/files/investors/library/materials/2020/pdf/RD%20Day%202020_E.pdf); conjugated with deruxtecan, a camptothecin derivative
Anticipated events | None |
Factor(s) contributing to discontinuation | None |