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TH0318 is an autologous T-cell receptor (TCR) engineered T-cell therapy targeting the Human Endogenous Retrovirus-E (HERV-E) antigen. Developed by T-Cure Bioscience in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), the therapy is designed to treat clear cell renal cell carcinoma (ccRCC). The HERV-E antigen is selectively expressed in ccRCC cells due to the inactivation of the von Hippel-Lindau (VHL) gene, making it a highly specific target with minimal expression in healthy tissues. TH0318 involves the genetic modification of a patient's own T cells to express a TCR that recognizes the HERV-E peptide presented by HLA-A*11:01. The therapy is currently being evaluated in Phase 1 clinical trials for patients with metastatic ccRCC who have failed standard therapies.
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