Dynamic42 participates in EU project to develop innovative model systems for the evaluation of immunomodulatory therapeutics
Making novel therapeutics safer: Interdisciplinary EU consortium develops innovative model systems for the evaluation of immunomodulatory therapeutics Dynamic42 GmbH participates in EU project to develop innovative model systems for the evaluation of immunomodulatory therapeutics
The development of immunomodulatory drugs and therapies has experienced a new impetus due to the recent successes in immuno-oncology. But it is not only in cancer medicine that cell and gene therapies are increasingly establishing themselves as alternatives or supplements to the classical small-molecule drugs and biologicals.
However, a major challenge in the development of new therapies is and remains their preclinical evaluation in terms of efficacy and safety. The biggest problem here is the complexity of the human immune system. In a diseased state, for example in cancer, autoimmune or inflammatory diseases, the cells of the immune system interact differently than in a healthy state. While preclinical studies have so far mainly investigated the basic toxicity of a new therapeutic agent on the (healthy) immune system, there is a lack of non-clinical models that accurately capture the individual interactions of the human immune system in the pathogenic state.
The EU consortium inSAVAR (Immune Safety Avatar: nonclinical mimicking of the immune system effects of immunomodulatory therapies) addresses this shortcoming with new concepts for testing immunomodulatory therapies. The aim is to improve existing and develop new model systems in order to:
- identify undesirable side effects of new therapies on the immune system
- develop new biomarkers for the diagnosis and prognosis of immune-mediated pharmacologies and toxicities
- explore toxicity mechanisms and the potential for their mitigation through therapeutic interventions in more detail.
- The project thus aims to lay the foundations for new, Europe-wide standards in drug development.
The interdisciplinary consortium inSAVAR comprises 28 international partners from 11 nations under the scientific coordination of the Fraunhofer Institute for Cell Therapy and Immunology IZI (Leipzig, Germany) and Novartis (Basel, Switzerland). The partners include university and non-university research institutions, pharmaceutical and biotechnology companies and regulatory authorities.
Dynamic42 GmbH will contribute its expertise in the handling and integration of human immune cells into existing and newly developed in vitro model systems. In addition, assays for promising models and applications will be adapted and developed for routine (industrial) use.
The project is funded by the European Union over a period of 6 years with a total of 11 million Euros (GA-Nr. 853988). The industrial partners are contributing the same amount to the project as their own contribution.
Further information on the project will be available on the website www.imsavar.eu from February 2020.
BioSci Consulting, Belgium
bluebird bio, Inc, USA
Boehringer Ingelheim, USA
Covance, Great Britain
Dynamic42 GmbH, Germany
F. Hoffmann-La Roche Ltd, Switzerland
Fraunhofer Institute for Cell Therapy and Immunology IZI, Germany
Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Germany
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany
Fraunhofer Institute for Material and Beam Technology IWS, Germany
Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Germany
IT for Translational Medicine S.A. (ITTM), Luxembourg
Leiden University, The Netherlands
Lunds University, Sweden
Hannover Medical School (MHH), Germany
Innsbruck Medical University, Austria
Merck Sharp & Dohme Corp, USA
Merck KGaA, Germany
Novartis AG, Switzerland
Paul Ehrlich Institute (PEI), Germany
T-CURX GmbH, Germany
Transgene SA, France
Universitetet i Oslo, Norway
University of Leipzig, Germany
University of Twente (UT), The Netherlands
University of Luxembourg, Luxembourg
University Hospital Jena, Germany
University Hospital Tübingen, Germany
University Hospital Würzburg, Germany
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