Biologic
UniProt P07766
Teplizumab
Tzield
- Mechanism of action
- CD3-directed T-cell modulator (monoclonal antibody)
- In plain language
- An antibody that calms down the immune cells attacking the pancreas, buying time before type 1 diabetes fully develops.
- How it works
- Teplizumab-mzwv is a humanized IgG1-kappa monoclonal antibody that binds CD3, a signaling component of the T-cell receptor complex expressed on CD4-positive and CD8-positive T lymphocytes. Binding causes internalization of the teplizumab/CD3 complex from the T-cell surface and delivers a partial agonist signal rather than full receptor activation, producing lymphopenia without T-cell depletion. This partial signaling is thought to deactivate pancreatic beta-cell-autoreactive T lymphocytes while increasing the proportion of circulating regulatory T cells and exhausted CD8-positive T cells, collectively slowing the autoimmune destruction of insulin-producing beta cells that drives progression from Stage 2 to Stage 3 type 1 diabetes.
- Therapeutic applications
- Per FDA-approved labeling, TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D, and to delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. Approval was based on the TN-10 trial, in which a single 14-day course delayed median progression to Stage 3 T1D to 49.5 months versus 24.9 months with placebo.
- Class
- Monoclonal antibody
- Therapeutic area
- Metabolic / Diabetes
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