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GNTI-350 is an engineered regulatory T cell (EngTreg) therapy developed by GentiBio for the treatment of B cell-driven and T cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE). The therapy utilizes GentiBio's proprietary platform to create "super Tfr" (T follicular regulatory) cells. These cells are engineered to stably express FOXP3 for lineage commitment and a CD19-targeted chimeric antigen receptor (CAR) for selective engagement with B cells. Additionally, GNTI-350 incorporates a chemically-inducible IL-2–like signaling complex (CISC), which supports Treg function and persistence through the administration of rapamycin, even in IL-2–deficient autoimmune environments. In preclinical studies, GNTI-350 has demonstrated the ability to disrupt germinal center pathology, suppress T follicular helper (Tfh) cells, and reduce disease-driving autoantibodies and kidney damage markers.
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