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Teplizumab, also known as hOKT3γ1(Ala-Ala), is a humanized, anti-CD3 monoclonal antibody. Teplizumab has been engineered to alter the function of the T lymphocytes that mediate the destruction of the insulin-producing beta cells of the islets of the pancreas. Teplizumab binds to an epitope of the CD3-epsilon chain expressed on mature T cells and by doing so, may modulate the immunologic response underlying multiple autoimmune diseases, including Type 1 Diabetes (T1D). Specifically, teplizumab may inhibit unwanted effector T cells and enhance beneficial regulatory T cell functions, thus promoting immune tolerance.
If teplizumab is effective and has the ability to preserve or protect beta cells of the pancreas, patients may require less injected insulin and their blood glucose levels may be easier to control. Teplizumab represents a potential paradigm shift in the management of autoimmune disease that focuses on the induction of tolerance rather than broad spectrum immunosuppression.
The ongoing Phase 2 clinical study, titled “At Risk”, is intended to evaluate whether teplizumab can help to prevent or delay the onset of T1D in relatives determined to be at very high risk for developing the disease. The study is sponsored by TrialNet and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.
In June 2011, MacroGenics announced the publication in The Lancet of results from Protégé, a Phase 3 clinical study of teplizumab in T1D. The primary clinical endpoint was not met. However, exploratory, post-hoc analyses suggest that teplizumab, when used in a full dose regimen, may preserve C-peptide and increase the percentage of patients requiring very low doses of insulin compared to those on placebo. The peer-reviewed article appearing in The Lancet provided the results of per protocol as well as exploratory, post hoc analyses. The findings suggest that “future studies of immunotherapeutic intervention with teplizumab might have increased success in prevention of a decline in beta-cell function (measured by C-peptide) and provision of glycaemic control at reduced doses of insulin if they target patients early after diagnosis of diabetes and children.”
MacroGenics retains full worldwide rights to teplizumab.