Rinatabart sesutecan Clinical ADC

Antibody Information

Entry ID	1134
INN	Rinatabart sesutecan
Status	Clinical
Drug code(s)	GEN1184, PRO1184, Rina-S
Brand name	None
mAb sequence source	mAb human
General Molecular Category	ADC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	Proprietary hydrophilic linker (Cleavable)
Ave. DAR	None
Conjugated/fused moiety	Topoisomerase I inhibitor, Exatecan
Discovery method/technology	None

Therapeutic information

Target(s)	FR alpha
Indications of clinical studies	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)	July 15, 2022
Start of Phase 2
Start of Phase 3	February 15, 2025
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	Genmab
Licensee/Partner	None
Comments about company or candidate	Phase 3 study NCT06619236 started in February 2025 May 21, 2024 – Genmab A/S announced that it has completed its acquisition of ProfoundBio, Inc. NCT05579366 Phase 1 started in Dec 2022. August 3, 2022: ProfoundBio, an oncology biotherapeutics company focused on the development of novel antibody-based therapeutics, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug application (IND) to evaluate PRO1184 in patients with advanced cancer. The Phase 1 study will evaluate the safety, activity and pharmacokinetics of PRO1184 in patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma.
Full address of company	ProfoundBio US Co., 401 Terry Ave N, Seattle, WA 98109 North America United States of America https://www.profoundbio.com/

Description/comment

PRO1184 is an antibody-drug conjugate comprising a folate receptor alpha (FRa) directed antibody conjugated to an exatecan payload with a novel, proprietary hydrophilic linker. Preclinical results presented in 2022 (https://aacrjournals.org/cancerres/article/82/12_Supplement/1085/701084). Fc engineered with L234A/L235A mutations.
Company has multiple ADCs in preclinical development: http://www.profoundbiosz.cn/intro/3.html

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None