Trastuzumab pamirtecan Clinical ADC

Antibody Information

Entry ID	551
INN	Trastuzumab pamirtecan
Status	Clinical
Drug code(s)	DB-1303, BNT323
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	TBD
Linker	Enzymatically cleavable peptide linker
Ave. DAR	___
Conjugated/fused moiety	Topoisomerase I inhibitor, P1003
Discovery method/technology	None

Therapeutic information

Target(s)	HER2
Indications of clinical studies	Endometrial cancer, Breast 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)	December 15, 2021
Start of Phase 2
Start of Phase 3	December 15, 2023
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	Duality Biologics (Suzhou) Co. Ltd.
Licensee/Partner	BioNTech SE
Comments about company or candidate	NCT06340568 Phase 3 in endometrial cancer due to start in November 2024. NCT06265428 Phase 3 in breast cancer started in Jan 2024. Jan 22, 2023: BioNTech SE and Duality Biologics announced that the first patient with metastatic breast cancer has been treated in a pivotal Phase 3 trial evaluating the efficacy and safety of BNT323/DB-1303, 'NCT06018337 Phase 3 in breast cancer started in Nov 2023. Jan 2023: Duality Biologics has announced that the U.S. Food and Drug Administration granted Fast Track Designation to the antibody-drug conjugate DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment. NCT05150691 Phase 1 started in Jan 2022; the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 will be assessed in patients with advanced/metastatic solid tumors.
Full address of company	Unit 1105-1106, #868 Yinghua Road, Pudong New District, Shanghai, China Asia China https://dualitybiologics.com/

Description/comment

DB-1303 is composed of an anti-HER2 monoclonal antibody, enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor P1003.
https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.3023

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None