IMMUNOBIOGRAM® (IMBG) CLINICAL STUDIES IN KIDNEY TRANSPLANTATION

The most important challenge in Kidney Transplantation is to achieve the long-term survival of the transplanted organ, as 50% of patients will suffered a graft loss in the next 10 years following transplantation (unadjusted data).

To avoid the risk of graft rejection, patients require long term treatment with immunosuppressive drugs (IMS) but this treatment can also cause severe adverse events.

Currently IMS regimens are established empirically, based only on guidelines, monitoring of IMS plasmatic levels and side effects. The current strategy may lead to either under-immunosuppression (resulting in rejections) or over-immunosuppression (resulting in side effects).

The risk of graft rejection and the burden of adverse events are two of the most important challenges for the clinicians in the management of Kidney Transplant Patients. An adequate adjustment of immunosuppressive medications is needed to prevent them.

Currently there is no tool in clinical practice that allows to predict the individual immune response of each patient to the individual immunosuppressive drugs.

50% of patients in Kidney Transplantation

will suffer a graft loss in the next 10 years following transplantation

Immunobiogram ® is a first-in-class, blood-based in vitro diagnostic (IVD) bioassay, that can provide a pharmacodynamic readout of the immune response of individual patients to a battery of immunosuppressants commonly used in kidney transplantation and has the potential to help clinicians to individualize IMS treatment adjustment.

Immunobiogram ® has been tested for Kidney Transplantation (KT) in two clinical studies that belong to the TRANSBIO Project (Cellular BIOtechnology for prognosis and monitoring in renal TRANSplantation), supported by the European Union Horizon 2020 Programme for Research and Innovation as a SME instrument Phase 2 under grant agreement Nº 733248:

BH-PILOT 2015

BH-Pilot 2015 Study was a proof-of-concept clinical study performed in 2015-2016 in two important University Hospitals from Madrid. The study included 70 renal-transplanted patients at least 1 year after the transplant (immunosuppression maintenance period), and classified as high- immunological-risk, low-risk and standard based on their clinical and immunological characteristics.

TRANSBIO STUDY

TRANSBIO Study is an international, multicenter clinical study performed to confirm BH-Pilot 2015 study results and to achieve the technical validation of the IMBG. It was performed in nine major University Hospitals in Europe and USA with more than 200 patients recruited.

IMBG provides an individualized patient response pattern to immunosuppressive medication. Sensitivity ranges can be determined in each patient for each of the drugs tested.
There is an association between the sensitivity (response) to the individual IMS that the patient is taking measured in vitro with Immunobiogram ® and the patients´ clinical outcomes.
The probability of a poor clinical outcome (in terms of rejection) increases as the sensitivity (pharmacodynamic response) to the individual IMS decreases.
Immunobiogram ® results for each patient and individual IMS can be represented as a percentile (P). The lowest values (P10) mean a lower sensitivity to the IMS, what indicates that the patient is not responding well to the inhibition action of the IMS on immune cells in relation to a reference population.
The percentile can move from the lowest sensitivity to the IMS (percentile 10) to the highest one (percentile 90). A change in the percentile value towards a lowest sensitivity percentile is associated with an increase in the rejection risk.
Immunobiogram ® also provides a global score of sensitivity towards all the IMS that de patient is taking in relation to a reference population.
Immunobiogram ® showed a good intrasubject and intertime consistency for the major parameters of the dose/response curves