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Immune Safety Avatar: nonclinical mimicking of the immune system effects of immunomodulatory therapies

Project description

Research platform for safer immunomodulating therapy

Modulation of the immune system is emerging as an attractive approach for treating a plethora of conditions from immune-mediated diseases to cancer. However, responses in clinical trials have been variable, underscoring the need for better biomarkers, endpoints and monitoring approaches. Towards this goal, the EU-funded imSAVAR project will develop a platform for testing the safety and efficacy of immunomodulators. Researchers will work on novel assays, reliable models and predictive biomarkers to improve the safety of immunotherapy. In collaboration with big pharmaceutical companies, the ultimate goal of the imSAVAR effort is to transfer the knowledge from preclinical models into first-in-human studies.


The vision of Immune Safety Avatar (imSAVAR) is to develop a platform for integrated nonclinical assessments of immunomodulatory therapy safety and efficacy. Existing nonclinical models do not adequately represent the complexity of the immune system and its interactions in both immunoncology and immunmediated diseases. They also do not accurately reflect the diversity of response to new therapies that is seen in clinical medicine.
We will, thus, constantly refine existing and develop new nonclinical models with the final goal of validation aiming at: (i) understanding the value of nonclinical models for predicting efficacy and safety of immunomodulators incorporating cellular high throughput assays, complex organisms models and micro physiological systems, (ii) developing new endpoints and better monitoring approaches for immune function tests, and (iii) designing cellular and molecular biomarkers for early detection of adverse effects. The platform imSAVAR will be based upon case studies for prioritized therapeutic modalities and has been built around institutes of the Fraunhofer-Gesellschaft which has strong track records in applied science and in particular toxicology. The consortium will improve the prediction of the transferability of safety and efficacy of immunomodulators from pre-clinical models to first-in-human studies in collaboration with the private sector, pharma, regulators and technology providers. We will share experience on customized models that can be deployed (w.r.t. the 3Rs principles), establish the necessary infrastructure, conduct the analyses and provide wider disease domain expertise. This conjoint effort assures that the platform imSAVAR constantly benefits the field of immune safety evaluation, and will generate opportunities for European businesses. A guiding principle of this consortium is the meaningful engagement of multiple stakeholders including patients and regulators. A multi-stakeholder community will be established.



Net EU contribution
€ 3 568 773,55
Hansastrasse 27c
80686 Munchen

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Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Research Organisations
Other funding
€ 260 000,00

Participants (27)