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TK-8001 is an investigational T cell receptor (TCR) engineered T cell therapy (TCR-T) developed by T-knife Therapeutics for the treatment of advanced-stage or metastatic solid tumors that express the melanoma-associated antigen gene-A1 (MAGE-A1). The therapy involves autologous CD8+ T cells that are genetically modified via retroviral transduction to express a high-affinity, MAGE-A1-specific TCR identified using the MyT Platform. This platform utilizes transgenic mice with human TCRαβ gene loci immunized with human tumor antigens to discover naturally optimized, high-affinity and specific TCRs. The mechanism of action relies on these engineered CD8+ T cells recognizing and binding to MAGE-A1 epitopes presented on HLA-A*02:01-positive tumor cells, leading to targeted cytotoxicity and interferon-gamma release against cancer cells. Preclinical studies have shown superior anti-tumor activity compared to human donor-derived MAGE-A1-specific TCRs. TK-8001 is currently being evaluated in the IMAG1NE Phase 1/2 clinical trial for patients with MAGE-A1 positive solid tumors who have exhausted other therapeutic options[1][3][5][7][8].
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