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ALA-001 is an autologous, non-viral T-cell receptor engineered T-cell (TCR-T) therapy developed by Alaunos Therapeutics for the treatment of various solid tumors. The therapy utilizes the proprietary Sleeping Beauty transposon/transposase system, a non-viral gene transfer method, to integrate genes encoding specific TCRs into a patient's own T cells. This approach is designed to target shared tumor-specific "hotspot" mutations in key oncogenic genes, specifically KRAS, TP53, and EGFR, presented by specific Human Leukocyte Antigen (HLA) alleles. ALA-001 employs a library-based strategy where pre-selected TCRs are matched to a patient's specific mutation and HLA profile. The engineered T cells are administered intravenously following lymphodepletion to recognize and eliminate cancer cells expressing the target neoantigens. In August 2023, Alaunos Therapeutics announced a strategic pivot and the termination of the Phase 1/2 trial for ALA-001 to focus on other priorities.
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