TAbS







Raludotatug deruxtecan Clinical ADC

Antibody Information

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

Therapeutic information

Target(s) Cadherin-6
Indications of clinical studies Ovarian cancer, Phase 1 in Renal Cell Carcinoma and Ovarian Tumors
Primary therapeutic area Cancer

Development stage information


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 information

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/

Description/comment

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

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None