Immune Monitoring for RIsk STratification in Solid Organ Transplant Recipients

Informazioni relative al progetto

ImMoRiSt

ID dell’accordo di sovvenzione: 710079

DOI

10.3030/710079

Progetto chiuso

Data della firma CE 11 Dicembre 2015

Data di avvio 1 Febbraio 2016

Data di completamento 31 Luglio 2016

Finanziato da

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

LOPHIUS BIOSCIENCES GMBH
Germany

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

Periodo di rendicontazione: 2016-02-01 al 2016-07-31

Sintesi del contesto e degli obiettivi generali del progetto

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).

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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.

Main Contractor