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trastuzumab pamirtecan
- Development stage
- Phase 3
- Lead developer
- Duality Biotherapeutics
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
Trastuzumab pamirtecan (BNT323/DB-1303) is a third-generation antibody-drug conjugate (ADC) targeting the human epidermal growth factor receptor 2 (HER2). Developed by BioNTech SE in collaboration with Duality Biologics, the ADC consists of a HER2-targeting monoclonal antibody (trastuzumab) covalently linked to a proprietary topoisomerase-1 inhibitor payload, pamirtecan, via a cleavable linker. The drug is designed to treat a broad range of HER2-expressing tumors, including those with low HER2 expression levels, by delivering the cytotoxic payload directly to tumor cells and utilizing a bystander effect to target adjacent cells. Trastuzumab pamirtecan has received Fast Track designation from the FDA and is currently being evaluated in Phase 3 clinical trials for HER2-positive and HER2-low breast cancer, as well as endometrial cancer, where it has demonstrated significant clinical activity.
- Other names
- trastuzumab pamirtecan
02
Targets
TOP1 (DNA Topoisomerase I)ERBB2 (Erb-b2 receptor tyrosine kinase 2)
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