Reliable biomarker analyses for drug development
Dr. Oliver Pötz
Work group leader at the Natural and Medical Sciences Institute (NMI) at the University of Tübingen | Signatope GmbH
Recipient: University of Tübingen
Funding: GO-Bio Phase I (01.04.2013 - 30.06.2017, 3.081.690 Euro)
Recipient: Signatope GmbH
Funding: GO-Bio Phase II (01.07.2017 - 30.06.2020, 2.256.485 Euro)
Biomarkers are becoming increasingly important for the field of drug development. The presence and concentration of these molecules give insights into the progression of a disease. Biomarkers can also improve the development of drug candidates by providing early and reliable indications of possible organ damage. For the pharmaceutical industry, such indicators are thus of enormous value for toxicity testing, in which drugs are examined for their influence on the liver, kidney and blood vessels of animals.
To facilitate and accelerate research in the area of biomarkers, biochemist Oliver Pötz has combined an antibody-based procedure with methods of mass spectrometry. The innovative aspect of this analytical method is the ‘enrichment’ of the marker molecules. This enables the applied antibodies to recognise a very small and specific area of the protein under investigation. This has functioned equally well in samples from mice, rats, dogs, monkeys and humans. As a result, it is possible to examine different species with just a single antibody, which greatly simplifies and speeds up the procedure compared to conventional tests. Biomarker molecule fragments that have been enriched with the immunoaffinity method can then be identified and quantified using mass spectrometry.
In the GO-Bio project, Pötz and his team are planning preclinical studies for the validation of the test system for biomarker analysis, which will be used in the detection of kidney damage. Further test procedures for liver and blood vessel damage are also envisaged. The intention is to found a company on the basis of these results, which will offer the so-called ‘XIM tests' (cross-species immunoassays) as a service to the pharmaceutical industry. In the medium term, the team is working towards the discovery of new biomarkers, as well as their validation and marketing, which will be pursued together with partners in the pharmaceutical industry.
In the first GO-Bio funding phase, the founding team successfully established the XIM platform technology. As a result of this work, Signatope GmbH was spun off from the NMI Natural and Medical Sciences Institute at the University of Tübingen at the end of 2016.
In the current second GO-Bio funding phase, Signatope GmbH intends to further develop the MS-based immunoassays developed to date for the detection of liver and vascular damage. As an overarching task, the team intends to expand the existing antibody portfolio for biomarker analysis. The detailed validation of the technology will be performed by retrospective analysis of preclinical and clinical samples from a drug development program.