VivoGenie Anti-Human CD3 (Teplizumab) Biosimilar (IVMB0474)

Type I diabetes is a chronic autoimmune disease that destroys insulin-producing beta-cells in the islets of Langerhans, leading to a dependence on exogenous insulin for survival¹. Teplizumab (TZIELD) is a humanized, anti-CD3ε IgG1κ monoclonal therapeutic that delays the onset of Stage 3 Type 1 diabetes^{1, 2}. CD3ε plays an essential role in T cell development and is part of the T cell-receptor CD3-complex, which acts as an external signal transducer³. Defects in CD3ε cause immunodeficiency and have been linked to susceptibility to type I diabetes in women.

Teplizumab is an Fc receptor-nonbinding anti-CD3 antibody⁴ whose Fc region is mutated (L234A; L235A) to reduce effector functions². When Teplizumab is administered by intravenous infusion once daily for 14 consecutive days, it reduces the loss of beta-cell function¹. Teplizumab treatment modifies CD8+ T lymphocytes, which are thought to kill beta-cells, to display a partially exhausted phenotype associated with delayed disease progression^{1, 5}. Teplizumab delays the median onset of Stage 3 Type 1 diabetes by 2 years compared to placebo^{1, 2}. Additionally, the effects of treatment persist over time. The median years to diabetes diagnosis after Teplizumab treatment is ~ 5 years compared to ~ 2 years in the placebo-treated group⁶.

In November 2022, the United States Food and Drug Administration approved Teplizumab injection to delay the onset of Stage 3 Type 1 diabetes in adults and pediatric patients aged 8 years and older who have Stage 2 Type 1 diabetes⁷.