Challenge 4: Improving the predictive capacity of in vitro cytokine release assays to reduce animal use and drug attrition

Budget: £500,000

Biologics form approximately 30% of the global drugs pipeline. Immune responses caused by these drugs, including desired pharmacology and adverse events, are assessed in preclinical studies, primarily using the cynomolgus monkey.

In vitro assays which accurately predict immune responses, including the likelihood of a cytokine storm, would reduce the number of monkeys used by avoiding drugs which are destined to fail on safety or efficacy grounds being taken into preclinical studies.

The aims of this Challenge are two-fold. Firstly, to develop in vitro human cell-based models for the testing of antibody-based therapeutics that will allow the prediction of human cytokine release. Secondly, to develop a parallel assay with non-human primate cells (e.g. cynomolgus monkey) to predict cytokine release in preclinical safety assessment.