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TI-168 is an autologous T-cell receptor (TCR) engineered regulatory T-cell (Treg) therapy designed to treat Hemophilia A in patients who have developed inhibitors against Factor VIII (FVIII). Developed by TeraImmune (acquired by Baudax Bio), the therapy utilizes human Tregs engineered with a specific TCR to target and suppress the immune response against FVIII. By inducing immune tolerance, TI-168 aims to eliminate FVIII inhibitors, potentially allowing for the effective use of standard FVIII replacement therapies. The FDA has cleared an Investigational New Drug (IND) application for a Phase 1/2a clinical trial.
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