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BC3448 is a first-in-class bispecific antibody that targets both CD3 on T cells and epidermal growth factor receptor (EGFR) on tumor cells. By binding to these two targets, BC3448 recruits T cells to tumor cells with high EGFR expression, resulting in T cell-driven tumor cell killing. The molecule is engineered with differential binding affinities—stronger for EGFR than for CD3—to reduce the risk of cytokine release syndrome (CRS), a common safety concern with CD3-based bispecific antibodies. Preclinical studies have shown antitumor activity across multiple solid tumors expressing high levels of EGFR, including those resistant to EGFR tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. Indications under development include non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), metastatic colorectal cancer (mCRC), and esophageal cancer (ESC). The drug is being developed by BioCity Biopharma and has entered Phase 1 clinical trials in the United States following FDA clearance of its Investigational New Drug application[1][2][3][4].
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