|Source||Humanized (from mouse)|
|Mol. mass||145.8 kDa|
|(what is this?)|
Teplizumab (also known as MGA031 and hOKT3γ1(Ala-Ala)) is a humanized monoclonal antibody that is used as an immunosuppressive drug. The Fc region of this antibody has been engineered to have Fc receptor non-binding (FNB) properties. Teplizumab was originally developed at Columbia University, and was then further developed at MacroGenics, Inc.
This antibody has been used in clinical trials with the aim of protecting the remaining β-cells in newly diagnosed type 1 diabetes mellitus patients, but "these agents [i. e. anti-CD3-antibodies] alone do not restore normal glucose control".
Eli Lilly licensed the drug back in 2007 from MacroGenics with a $41 million upfront and a billion dollars pledged for milestones.
It is in Phase-3 clinical trials for Type-1 DM. One-year data from one phase III trial was disappointing.
- Woodle ES, Bluestone JA, Zivin RA, Jolliffe LK, Auger J, Xu D, Thistlethwaite JR (June 1998). "Humanized, nonmitogenic OKT3 antibody, huOKT3 gamma(Ala-Ala): initial clinical experience". Transplant. Proc. 30 (4): 1369–70. doi:10.1016/S0041-1345(98)00278-4. PMID 9636555.
- Brown WM (April 2006). "Anti-CD3 antibody MacroGenics Inc". Curr Opin Investig Drugs 7 (4): 381–8. PMID 16625825.
- Herold KC, Gitelman SE, Masharani U, Hagopian W, Bisikirska B, Donaldson D, Rother K, Diamond B, Harlan DM, Bluestone JA (June 2005). "A single course of anti-CD3 monoclonal antibody hOKT3gamma1(Ala-Ala) results in improvement in C-peptide responses and clinical parameters for at least 2 years after onset of type 1 diabetes". Diabetes 54 (6): 1763–9. doi:10.2337/diabetes.54.6.1763. PMID 15919798.
- Kaufman A, Herold KC (May 2009). "Anti-CD3 mAbs for treatment of type 1 diabetes". Diabetes/metabolism Research and Reviews 25 (4): 302–6. doi:10.1002/dmrr.933. PMID 19319985.
- "MacroGenics and Lilly Ponder Future of Diabetes mAb after Phase III Flop". 21 Oct 2010.
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