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CORDIS

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

Projektbeschreibung

Forschungsplattform für eine sicherere Immunmodulationstherapie

Die Modulation des Immunsystems entwickelt sich zu einer attraktiven Möglichkeit, um zahlreiche Erkrankungen, von Autoimmunerkrankungen bis hin zu Krebs, zu behandeln. Die Ergebnisse aus klinischen Studien fielen jedoch unterschiedlich aus, was den Bedarf an besseren Biomarkern, Endpunkten und Überwachungskonzepten unterstreicht. Dazu wird das EU-finanzierte Projekt imSAVAR eine Plattform entwickeln, mit der die Sicherheit und Wirksamkeit von Immunmodulatoren getestet werden soll. Das Forschungsteam wird an neuartigen Assays, zuverlässigen Modellen und prädiktiven Biomarkern arbeiten, um die Immuntherapie sicherer zu gestalten. In Zusammenarbeit mit großen Pharmakonzernen sollen dank imSAVAR aus präklinischen Modellen gewonnene Erkenntnisse auf erste Studien am Menschen übertragen werden.

Ziel

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.

Koordinator

FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
Netto-EU-Beitrag
€ 3 568 773,55
Adresse
HANSASTRASSE 27C
80686 Munchen
Deutschland

Auf der Karte ansehen

Region
Bayern Oberbayern München, Kreisfreie Stadt
Aktivitätstyp
Research Organisations
Links
Gesamtkosten
€ 3 828 773,55

Beteiligte (27)