Ifinatamab deruxtecan Clinical ADC

Antibody Information

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

Therapeutic information

Target(s)	B7-H3
Indications of clinical studies	Esophageal Squamous Cell Carcinoma, Small cell lung cancer, Solid tumors
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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 information

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/

Description/comment

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

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None