Making novel therapeutics safer

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12/03/2019 14:23

Making novel therapeutics safer

Fraunhofer Institute for Cell Therapy and Immunology IZI IZI Kommunikation

    Interdisciplinary EU consortium, coordinated by Fraunhofer Institute for Cell Therapy and Immunology IZI, develops innovative model systems for the evaluation of immunomodulating therapeutics

    The development of immunomodulatory agents and therapies has received fresh impetus following the latest successes in immuno-oncology. And cancer medicine is not the only area where cell and gene therapies are increasingly taking hold as alternatives or complementary to classic, low-molecular drugs and biologicals.

    A significant challenge facing the development of new therapies, however, is and remains their preclinical evaluation in terms of efficacy and safety. The greatest problem here is the complexity of the human immune system. When a person is ill, for example in the case of cancer, autoimmune or inflammatory diseases, the cells of the immune system interact differently to when a person is healthy. While preclinical tests have so far mainly looked at the basic toxicity of a new therapeutic agent in terms of 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 imSAVAR (Immune Safety Avatar: nonclinical mimicking of the immune system effects of immunomodulatory therapies) is addressing this shortfall by coming up with new ways of examining immunomodulatory therapies. The aim here is to improve existing model systems and develop new ones in order to:

    - identify adverse side effects of new therapies affecting the immune system,
    - develop new biomarkers for diagnosing and predicting immune-mediated pharmacology and toxicities, and
    - further explore toxicity mechanisms and the potential for their mitigation via therapeutic interventions.

    The project hopes to lay the foundations for new Europe-wide standards in drug development.

    The interdisciplinary imSAVAR consortium is made up of 28 international partners from 11 nations and is being coordinated by the Fraunhofer Institute for Cell Therapy and Immunology (Leipzig, Germany) and Novartis. Partners include university and non-university research facilities, pharmaceutical and biotechnology companies, as well as regulatory authorities.

    Besides coordinating the overall project, Fraunhofer IZI will focus in particular on predicting and evaluating adverse effects caused by novel immunotherapies specifically developed for oncological and inflammatory diseases. This involves optimizing and developing respective models (in situ, in vitro, in vivo, in silico) and biomarkers that take into account the highly complex modes of action typical of immunotherapies.

    This project receives funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853988. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

    Further information on the project will be available from February 2020 on the website

    imSAVAR project consortium:
    BioSci Consulting, Belgium
    bluebird bio, Inc. United States
    Boehringer Ingelheim, United States
    Covance, United Kingdom
    Dynamic42 GmbH, Germany
    F. Hoffmann-La Roche Ltd, Switzerland
    Fraunhofer Institute for Cell Therapy and Immunology IZI, Germany
    Fraunhofer Institute for Interfacial Engineeringand 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
    Hannover Medical School (MHH), Germany
    IT for Translational Medicine S.A. (ITTM), Luxembourg
    Jena University hospital, Germany
    JDRF, United States
    Leiden University Medical Center (LUMC), The Netherlands
    Leipzig University, Germany
    Lund University, Sweden
    Merck KGaA, Germany
    Merck Sharp & Dohme Corp., United States
    Novartis AG, Switzerland
    Medical University of Innsbruck, Austria
    Paul-Ehrlich-Institut (PEI), Germany
    Sanofi, France
    Servier, France
    T-CURX GmbH, Germany
    Transgene SA, France
    University Hospital of Würzburg, Germany
    University Hospital of Tübingen, Germany
    University of Luxembourg, Luxembourg
    University of Oslo, Norway
    University of Twente, The Netherlands

    Contact for scientific information:

    Dr. Kristin Reiche
    Head of Bioinformatics Unit
    Fraunhofer Institute for Cell Therapy and Immunology
    Perlickstraße 1
    04103 Leipzig, Germany
    Phone +49 341 35536-5223

    Criteria of this press release:
    Business and commerce, Journalists, Scientists and scholars, Students
    Biology, Chemistry, Medicine
    transregional, national
    Cooperation agreements, Research projects

    imSAVAR Kick off Meeting on December 2. 2019 at Fraunhofer IZI in Leipzig

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