Drug intelligence / Profile preview

BNT3212

Development stage
Phase 2
Lead developer
BioNTech
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

BNT3212 is an antibody-drug conjugate (ADC) targeting both **EGFR** (Epidermal Growth Factor Receptor) and **HER3** (Human Epidermal Growth Factor Receptor 3), designed for the treatment of advanced solid tumors. The drug consists of a monoclonal antibody that binds to cells co-expressing EGFR and HER3, conjugated with a **topoisomerase I inhibitor** as its cytotoxic payload. Mechanistically, BNT3212 selectively binds tumor cells expressing both targets, leading to internalization and release of the cytotoxic agent, inducing cell death. BNT3212 was originally developed by Zhuhai Pumis Biotechnology and later acquired by BioNTech via the acquisition of Biotheus. The agent entered first-in-human clinical trials in 2025 and is currently in Phase 1/2 trials focused on safety, pharmacokinetics, preliminary efficacy, and dose finding for adults with advanced or metastatic solid tumors who have exhausted other treatment options[3][4][5][7].

Other names
anti-EGFR/HER3 ADCEGFRxHER3 ADCEGFRxHER-3 ADCEGFRxHER 3 ADC
02

Targets

ERBB3 (Erb-b2 receptor tyrosine kinase 3)EGFR (Epidermal growth factor receptor)

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