Current immunogenicity testing of drugs considers only the ‘antigenicity’ of the drug molecule, i.e. the ability of a compound to stimulate antibody production. However, true immunogenicity must also take into account anything that can cause an immune response or generate the conditions to initiate an immune response (e.g. tissue damage). Any drug has the potential to cause unwanted tissue damage which in turn increases the probability of immune-mediated (secondary) pathology. This is neglected in current models for assessing and analysing the human immune response to drugs and other chemicals.
Researchers from the UK-based company Immundnz have created the COMPIT platform to address this market need. COMPIT is a system of biological and analytical assays that combines novel cell lines, 3D scaffolds and primary cells to deliver an in vitro human cell-based immune system that recapitulates the in vivo human microenvironment. This offers researchers an advanced tool for analysing and predicting the human immune response that goes beyond the capability of currently available approaches.
Crucial to adoption of COMPIT will be to show proof of principle with relevant drug molecules. Immundnz is now seeking (bio)pharmaceutical partners able to provide access to a range of compounds to validate their model. Ideally this would include marketed compounds and molecules that failed due to immunogenicity (with associated data) according to current methods to show the clear and distinct benefits of the COMPIT platform.
Successful adoption of COMPIT has the potential to replace many of the animal models currently used in immunogenicity studies. A typical study consists of 60 experimental animals per compound to be studied, including tests such as lymph node assays, histopathology, and determination of antigen-specific and auto- antibodies. Such animal models are in many cases not relevant for translation to humans, especially in the case of studying immune response. COMPIT can robustly predict the human immune response, offering a viable alternative approach to replace some animal studies in immunogenicity testing. Additionally, by enabling the comprehensive analysis and prediction of the human immune response to drug molecules in vitro, COMPIT will reduce the number of compounds entering regulatory animal studies and therefore the number of animals used overall
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