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BD-011 is an autologous T-cell receptor engineered T-cell (TCR-T) therapy developed by Shenzhen BinDe Biological Technology (BinDeBio). The therapy involves the genetic modification of a patient's own T cells using a lentiviral vector to express a high-affinity T-cell receptor (TCR) specific for the New York esophageal squamous cell carcinoma 1 (NY-ESO-1) antigen. This TCR recognizes NY-ESO-1 peptides presented by the HLA-A*02:01 major histocompatibility complex. NY-ESO-1 is a cancer-testis antigen that is highly expressed in various malignancies but has restricted expression in normal tissues, making it a precise target for immunotherapy. Once re-infused into the patient, these engineered T cells are designed to selectively identify and eliminate NY-ESO-1-positive tumor cells. BD-011 is currently being investigated in Phase 1 clinical trials for the treatment of advanced solid tumors, including non-small cell lung cancer, esophageal cancer, and melanoma.
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