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hlx22
- Development stage
- Phase 3
- Lead developer
- Henlius
- Modality
- Nucleic Acid-Directed Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules, Vaccines & Immunotherapeutics, Covalent Small Molecules → Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
HLX22 is a novel humanized monoclonal IgG1 antibody that targets the human epidermal growth factor receptor 2 (HER2). It binds to the extracellular subdomain IV of HER2 at a site distinct from trastuzumab, allowing for simultaneous binding with trastuzumab to HER2 dimers on tumor cells. This dual blockade promotes internalization and degradation of HER2 dimers and enhances antitumor activity by inducing cytotoxic T-lymphocyte responses and antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells overexpressing HER2. HLX22 is being developed primarily for use in combination with trastuzumab (including biosimilar HLX02) and chemotherapy as first-line treatment for patients with HER2-positive metastatic gastric or gastroesophageal junction cancer. The drug has demonstrated manageable safety in clinical trials and has received FDA orphan drug designation for gastric cancer[1][4][5][6][7][8].
- Other names
- anti-HER2 monoclonal antibody HLX22anti-HER-2 monoclonal antibody HLX22anti-HER 2 monoclonal antibody HLX22
02
Targets
ERBB2 (Erb-b2 receptor tyrosine kinase 2)
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