Human PD-1 Antibody Families

Pembrolizumab & Nivolumab biosimilar isotypes: IgG1 and IgG4 (S228P)

Anti-human Programmed Cell Death 1 (PD-1) recombinant monoclonal antibodies

These anti-human PD-1 biosimilar antibodies comprise the variable region of either Pembrolizumab or Nivolumab and their original constant region or a different one with distinct effector functions (ADCC and ADCP).

Both Pembrolizumab and Nivolumab contain a human IgG4 (S228P) constant region and display low effector functions; the other biosimilars feature an IgG1 or IgG1fut (non-fucosylated) constant region that exhibits high effector functions. These non-therapeutic antibodies can be used for the comparative study of the complex interactions induced by their Fc domains.

 

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Key features

  • Each lot is functionally tested and validated
  • Choice of different anti-hPD-1 clones
  • Choice of different isotypes for high/low effector functions
  • The complete sequence of the antibody constructs has been verified
  • Absence of endotoxins determined by the EndotoxDetect assay

 

Pembrolizumab & Nivolumab background

Pembrolizumab, a humanized IgG4 (S228P) monoclonal antibody (mAb), and Nivolumab, a fully human IgG4 (S228P), both target the programmed cell death 1 (PD-1) receptor found on activated T cells, B cells, and myeloid cells. Under normal physiological conditions, PD-1 negatively regulates T cell activation thereby preventing autoimmunity. Under pathological conditions, cancer cells produce PD-L1 (programmed cell death 1 ligand 1), the agonist that binds and activates PD-1. Activated PD-1 enables cancer cells to evade the immune system. Pembrolizumab and Nivolumab bind and inhibit the PD-1 receptor, thereby resulting in the activation of T cells. Both antibodies contain an engineered hinge region mutation (S228P) designed to prevent the exchange of IgG4 molecules. Both are approved by the FDA and the EU for the treatment of a variety of cancer types, including non-small cell lung cancer, melanoma, and gastric cancer.

 

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