Making novel therapeutics safer: Interdisciplinary EU consortium develops innovative model systems for the evaluation of immunomodulatory therapeutics
The Hannover Unified Biobank is funded in the EU project for the development of innovative model systems for the evaluation of immunomodulating therapeutics.
The development of immunomodulating agents and therapies has been given a new boost by recent successes in immuno-oncology. However, it is not only in cancer medicine that cell and gene therapies are increasingly establishing themselves as an alternative or supplement to classic small molecules 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 SafetyAvatar: nonclinical mimicking of the immune system effects of immunomodulatory therapies) is addressing 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
- investigate toxicity mechanisms and the potential for their reduction through therapeutic measures in more detail.
The project 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 of 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.