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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

T-cell immunotherapy shows promise in treating patients with multiple sclerosis

Early results from a Phase 1 trial which is testing the safety and efficacy of an allogeneic T-cell immunotherapy show promise in treating multiple sclerosis. Results were presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) at Stockholm last week.

Multiple sclerosis (MS) is an acquired autoimmune disease of the central nervous system, resulting in axon loss and myelin damage. Epstein-Barr virus (EBV) is thought to play an important role in the pathogenesis of MS. San Francisco-based Atara Biotherapeutics’ T-cell therapy, AT188, is designed to target and attack EBV-infected B cells for treating MS.

The study is a multi-center, open-label, dose-escalation study evaluating the safety and efficacy of ATA188 in patients with progressive forms of MS. In this study, patients were treated across four dose cohorts (5 x 106, 1 x 107, 2 x 107 and 4 x 107 cells), with 6 patients per cohort.

The preliminary results presented were those from the first two cohorts and clinical outcomes of ATA188 were assessed at baseline and approximately 3, 6, and 12 months fol-low up from initial dose using recognized scales for MS symptoms, function and disability.

Safety results showed that ATA188 was well tolerated in the patients with no evidence of cytokine release syndrome, graft versus host disease or dose-limiting toxicities.

Data showed that all six of the patients in the second cohort who received 1 x 107 cells showed at least a partial improvement in MS symptoms at six months, while four of the six patients on the smaller dose showed a clinical decline and it was maintained at 12 months.

The trial has just completed dosing of patients in the fourth and final dose escalation cohort. Additional efficacy and safety results from cohorts 3 and 4 are expected in 2020.

Prof. Amit Bar-Or, Chief of MS Division, Department of Neurology, Perelman School of Medicine at the University of Pennsylvania commented: “I am encouraged by the well tolerated safety profile as well as early findings of potential efficacy in the ongoing ATA188 Phase 1 study. The outcome classification using multiple clinically recognized MS scales is an innovative approach, and I look forward to advancing the study alongside my colleagues for progressive MS patients who have limited treatment options and where continual clini-cal decline is expected.”

Source: ECTRIMS: Atara’s off-the-shelf T cells for EBV-driven MS show promise in small study; Website

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