imSAVAR – Making Novel Therapeutics Safer

Thanks to the latest successes in immune-oncology, developments of immune-modulating substances and therapies have experienced new advancements. Not only in cancer medicine do cell and gene therapeutics become increasingly established as an alternative or adjuvant treatment to classical low-molecular active ingredients (small molecules) and other biomedicines, but another important aspect in developing new therapeutics is their pre-clinical assessment (preclinical studies) with regard to efficacy and safety in their later use in humans. In this context, a major challenge is the complexity of the human immune system. In disease, for instance in cancer, autoimmune, or inflammatory disease, the cells of the immune system do not interact in the same way as in the healthy body. Up to now, preclinical studies have above all considered the underlying toxicity of a new therapeutic product on the (healthy) immune system. However, what is lacking are non-clinical models accurately showing the individual interactions of the human immune system in the state of disease.

The EU consortium imSAVAR (Immune Safety Avatar; non-clinical mimicking of the immune system effects of immunomodulatory therapies) addresses this inadequacy and elaborates new concepts for testing immunomodulatory therapies. The aim in this context is improving existing model systems and developing new ones. In doing so, the following targets are kept in focus:

• to identify adverse effects of new therapies on the immune system;
• to develop new biomarkers for the diagnosis and prognosis of immune-mediated pharmacological effects and toxicities, and
• to research into mechanisms of toxicity and the potential for reducing them by therapeutic measures in more detail.

The aim of the project is thus to establish the foundation for new standards in medicines development throughout Europe.

The interdisciplinary consortium imSAVAR comprises 28 international partners from eleven countries under the scientific co-ordination of the Frauenhofer Institute for Cell Therapy and Immunology (IZI) (Leipzig, Germany) and Novartis (Basel, Switzerland). The partners include university and non-university research institutes, pharmaceutical and biotechnology companies and regulatory authorities.

Apart from co-ordinating individual sub-projects, Professor Zoe Waibler's research group at the Paul-Ehrlich-Institut will focus in particular on optimising and developing pre-clinical in-vitro-models to be able to better judge the modes of action of immune therapies in future.

The term of the project will be six years. It will be funded by the European Union with eleven million euros in total (Project No. 853988). The same amount will be contributed to the project by industry partners.

imSAVAR Consortium

BioSci Consulting, Belgium
bluebird bio, Inc., USA
Boehringer Ingelheim, USA
Covance, UK
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-Institut for Material and Beam Technology IWS, Deutschland
Fraunhofer-Institut for Molecular Biology and Applied Ecology IME, Germany
IT for Translational Medicine S.A. (ITTM), Luxembourg
JDRF, USA
Leiden University, Netherlands
Lunds Universitet, Sweden
Medizinische Hochschule Hannover (Hanover Medical School MHH), Germany
Medizinische Universität Innsbruck (Medical University of Innsbruck), Austria
Merck Sharp & Dohme Corp., USA
Merck KGaA, Germany
Novartis AG, Switzerland
Paul-Ehrlich-Institut (PEI), Germany
Sanofi, France
Servier, France
T-CURX GmbH, Germany
Transgene SA, France
Universitetet i Oslo, Norway
Leipzig University, Germany
Twente University (UT), Netherlands
University of Luxembourg, Luxembourg
Jena University Hospital, Germany
Tübingen University Hospital, Germany
Würzburg University Hospital, Germany

Contact

Email: Zoe.Waibler@pei.de