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.

Fraunhofer IME is involved in three work packages and 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 vitro, in vivo) and biomarkers that take into account the highly complex modes of action typical of immunotherapies. The Fraunhofer Cluster of Excellence for Immune-Mediated Diseases CIMD with its core institutes IME, ITEM and IZI successfully applied for funding of this procect. CIMD investigates novel therapy and diagnosis options in the field of immune-mediated diseases.

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 www.imsavar.eu.

 

 

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 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

Hannover Medical School (MHH), Germany

IT for Translational Medicine S.A. (ITTM), Luxembourg

Jena University hospital, Germany

JDRF, United States

Leiden University, 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