ImSAVAR project

Development and assessment of innovative models for biopharmaceutical evaluation

In the treatment of diseases involving dysregulation of the immune system, such as cancer and autoimmune diseases, the focus is increasingly on therapies that modulate the immune system. To enable adequate testing of such immunomodulatory therapeutic approaches already in the non-clinical phase, suitable test systems have to be developed and adapted. This development, aimed at improving the transferability of preclinical safety and efficacy data to first-in-human studies, is at the focus of the "Immune Safety Avatar" platform, imSAVAR for short, funded by the Innovative Medicines Initiative (IMI).

© Fraunhofer ITEM, Ralf Mohr
Innovative model systems are being developed in the ImSAVAR project.

As part of this EU consortium, Fraunhofer ITEM is collaborating primarily in two work packages: “Immuno-oncology models” and “Innovative models for safety assessment of immuno-inflammatory disease therapeutics”. Interleukin-2 (IL-2) as a treatment option for cancer but also for autoimmune diseases has been selected for a first case study. IL-2 therapy had long been considered a promising treatment. Because of its massive side effects seen in clinical use, however, its usage has been drastically reduced. Due to the lack of nonclinical models accurately reflecting the individual interactions of the human immune system in the pathogenic state, adverse effects such as skin rashes could not be displayed in the nonclinical phase at that time. To enable better assessment of the safety also of future drugs, Fraunhofer ITEM researchers are developing innovative model systems for assessing immunomodulatory therapeutics. Immune-related adverse outcome pathways (irAOPs) provide the basis for combining individual clinical observations into an overall picture. The irAOPs allow the identification of possible key cellular and molecular events and the derivation of potential markers suggesting possible adverse effects.


Charline Sommer

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Charline Sommer

Preclinical Pharmacology and Toxicology

Fraunhofer Institute for Toxicology and Experimental Medicine