Pre-clinical models for drug selection and therapy design

The IACT program requires pre-clinical in vitro and in vivo models for two primary objectives:


1. To select potent and safe agonist IS-Abs. This is particularly important for the clinical development of lead Abs targeting anti-OX40 and 4-1BB and of more potent next-generation agonist IS-Abs.
2. To identify the most promising treatment regimens for clinical application of agonist IS-Abs, in particular those that involve combination with cytostatic treatment and/or anti-cancer vaccines.

Many of the models and assays required are already available in the participating laboratories. However, it is essential that for each of the experimental goals preferred experimental methodologies are selected and validated, and that the application of these methodologies is harmonized between the participating laboratories by means of standardize operating procedures (SOPs). Harmonization of these assays will not merely improve the reliability of assays. It will also allow benchmarking of new data against data from prior experiments, even if these have been performed by different partners. This is important, for instance for rapid assessment of the relative potency of next-generation IS-Ab variants as compared to our current lead IS-Abs.