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ImMoRiSt Report Summary

Project ID: 710079

Periodic Reporting for period 1 - ImMoRiSt (Immune Monitoring for RIsk STratification in Solid Organ Transplant Recipients)

Reporting period: 2016-02-01 to 2016-07-31

Summary of the context and overall objectives of the project

Every year ~ 40.000 patients throughout the EU are transplanted with a solid organ e.g. kidney, lung, liver, heart or receive a stem cell transplantation (SCT). Adequate and personalized treatment of the severe and in part life threatening clinical complications is impeded by the lack of appropriate diagnostic tests that help physicians to ascertain the exact dosage of immunosuppressive drugs and identify patients an increased risk for transplantation related complications. This is mandatory to avoid organ rejection and to diminish clinical complications caused by infections.

Lophius Biosciences GmbH has developed innovative immune monitoring tools, the so called “I-Scan” products providing important information on the strength and functional impairment of the cellular immune system in all groups of transplant (solid organ and stem cell) recipients within 24 h. The “I-Scans” diagnostics combine proprietary stimulants (either T activated® antigens of pathogens (applied in T-Track® CMV) or a cocktail of cell-type specific stimulants (T-Track® ImmunoScan)) with a highly sensitive readout method (IFN- ELISpot).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Both assay formats are based on Lophius’ proprietary “T-activation® technology” enabling a highly sensitive qualitative and quantitative measurement of cell-mediated immune function. The feasibility study performed during Phase 1 explored both, the clinical biomarker validation study and the best market entry strategy for two variant immune monitoring tools – the T-Track® CMV and the T-Track® ImmunoScan.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

A key outcome of the ImMoRiSt feasibility study was that stem cell transplantation (SCT) is the therapeutic area better suited as SOT to clinically validate and commercialize Lophius’ I-Scan IVD tests. Together with the study partners identified during the feasibility study Lophius will submit a Phase 2 application in the topic SMEInst-05-2016-2017: supporting innovative SMEs in the healthcare biotechnology sector, that includes the challenge “Clinical research for the validation of biomarkers and/or diagnostic medical devices”.

The clinical validation of a selected I-Scan product which is planned for Phase two of this innovation project will demonstrate that functional immune monitoring of a network of clinically relevant effector cells of the innate and adaptive immune system will substantially improve the outcome and aftercare of SCT recipients.

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