An immune response can be caused by a drug but also by drug-induced tissue damage. Any drug molecule has the potential to cause unwanted tissue damage. Current immunological risk assessment does not include immune response against tissue damage, causing unsafe drugs being tested in clinical studies or even being used in treatment. To fill this gap, Immundnz is developing COMPIT.
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. It can be used during preclinical development to assess drug-induced tissue damage and immunogenicity and to predict the human immune response as a result of a drug and drug-induced tissue damage .
COMPIT is focused on novel biomarkers for immune response due to (drug-induced) tissue damage using cutting edge analytics. It incorporates a mathematical system to score immunological risk and predict secondary pathology. COMPIT fits in the current scheme of preclinical studies.
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COMPIT can be applied to:
- Small molecule drugs
- Large molecule drugs
- Generics and biosimilars
Particularly the research and development of large molecules is evolving and expanding worldwide and requires a better and more in-depth insight into the human immune response.
COMPIT has several benefits:
- Better translation from preclinical studies to humans
- Reduction of the number of animal tests
- A more robust and comprehensive immunologic profile: improved safety and risk prediction thus reducing human health hazard risk
- Drug development can be terminated before costly advanced stages of drug development: reduced investments in non-viable drugs and reduced attrition rate
- Potential to improve drugs and make non-viable drugs accessible to patients
- Meeting changes to expected regulatory requirements on safety