Drug intelligence / Profile preview

BNT326 + itraconazole

Development stage
Unknown
Lead developer
BioNTech
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous, Oral
01

Overview

BNT326 + itraconazole is a **combination regimen** involving BNT326 (an investigational anti-HER3 antibody-drug conjugate) and itraconazole (an oral triazole antifungal). BNT326 is an ADC composed of an **anti-HER3 IgG1 monoclonal antibody** conjugated via a tripeptide linker to YL0010014, a novel **topoisomerase I inhibitor** payload. It is under development primarily for **advanced/metastatic non-small cell lung cancer (NSCLC)** with EGFR-activating mutations and for **hormone receptor-positive/HER2-negative breast cancer**, particularly in patients who have failed standard therapies[2][4][6][8]. Itraconazole, a clinical antifungal, has also been studied for off-label anticancer activity and is known as a potent **CYP3A4 inhibitor**[7]. Combination treatment here likely refers to either co-administration in clinical trials to manage drug-drug interactions or to exploit itraconazole’s potential metabolic or anticancer effects.

02

Targets

TOP1 (DNA Topoisomerase I)CYP3A4 (Cytochrome P450 3A4)ERBB3 (Erb-b2 receptor tyrosine kinase 3)

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