Teplizumab

Teplizumab (teplizumab-mzwv) is a humanized IgG1 kappa CD3-directed monoclonal antibody used to delay the onset of type 1 diabetes (T1D). T1D is an autoimmune condition in which T cell-mediated destruction of pancreatic β cells leads to loss of insulin production, impaired glycemic control, and reliance on exogenous insulin. Anti-CD3 therapy has traditionally been used to prevent graft-versus-host-disease in organ transplantation but more recently has been explored to prolong the onset of (T1D) in high-risk patients. Targeting T cells can be achieved through antibodies against the T cell receptor (TCR) component CD3. Although the mechanism of action of teplizumab has not been fully elucidated, it may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Fc-receptors can bind to the "tail-end" anti-CD3 antibodies in an antigen-non-specific manner and lead to severe adverse effects related to cytokine release syndrome (CRS). Teplizumab was designed as an Fc-non-binding antibody in order to reduce the incidence of CRS. On November 2022, teplizumab was approved by the FDA as the first drug that can delay the onset of type 1 diabetes.

Teplizumab (teplizumab-mzwv) is a humanized IgG1 kappa CD3-directed monoclonal antibody used to delay the onset of type 1 diabetes (T1D). T1D is an autoimmune condition in which T cell-mediated destruction of pancreatic β cells leads to loss of insulin production, impaired glycemic control, and reliance on exogenous insulin. Anti-CD3 therapy has traditionally been used to prevent graft-versus-host-disease in organ transplantation but more recently has been explored to prolong the onset of (T1D) in high-risk patients. Targeting T cells can be achieved through antibodies against the T cell receptor (TCR) component CD3. Although the mechanism of action of teplizumab has not been fully elucidated, it may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Fc-receptors can bind to the "tail-end" anti-CD3 antibodies in an antigen-non-specific manner and lead to severe adverse effects related to cytokine release syndrome (CRS). Teplizumab was designed as an Fc-non-binding antibody in order to reduce the incidence of CRS. On November 2022, teplizumab was approved by the FDA as the first drug that can delay the onset of type 1 diabetes.

Teplizumab is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

• Stage 3 Type 1 Diabetes Mellitus