Description
Background:
Ipilimumab is a first-in-class T-cell potentiator that works by blocking CTLA-4, a critical negative regulator of the anti-tumor T-cell response. In response to full T-cell activation, CTLA-4 is upregulated and competes with CD28 for CD80 and CD86 binding on antigen presenting cells but with significantly higher affinity, therefore downregulatingor deactivatingthe T cells. CTLA-4, therefore, downregulates T-cell responses and antigen presenting cell function, resulting in a decreased immune response to tumor associated antigens and immune tolerance. A fully humanized IgG1 monoclonal antibody, by blocking CTLA-4, Ipilimumab removes an inhibitory signal from reducing the activity of T lymphocytes. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Ipilimumab antibodies and may be used for monitoring immunogenicity.
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