Biohope validated its product IMMUNOBIOGRAM® (IMBG) in the TRANSBIO clinical study, that was satisfactorily concluded with the recruitment of nearly 200 patients from 9 international hospitals. The promising results were shown before KOLs and renowned experts at the European Society for Organ Transplantation (ESOT) 19th Congress.
The aim of TRANSBIO clinical study was to measure the immune response of patients undergone renal transplantation when exposed to the most common immunosuppressive drugs (IMs)(tacrolimus, cyclosporine, azathioprine, mycophenolic acid, prednisone, sirolimus and everolimus), using our blood-based in vitro pharmacodynamic test IMBG. Main study objectives were to evaluate the association of IMBG sensitivity/resistance patterns to IMs with the patients´ clinical evolution and to test the IMBG consistency.
The conclusions of the TRANSBIO clinical study were released to the public during the ESOT Congress 2019, hold in Copenhagen on 15-18th of September. Biohope participated in the scientific sessions with the publication of a poster titled “Analytical robustness and clinical consistency evaluation of a new in vitro diagnostic biotechnological immunoassay to help decision-making in adjustment of immunosuppressant therapy for kidney transplantation: TRANSBIO study”.
Moreover, we hold the closing TRANSBIO investigator meeting, with the attendance of 9 renowned European experts in renal transplantation that have participated as principal investigators and collaborators in the TRANSBIO clinical study.
TRANSBIO clinical study results validated IMBG as a functional tool for the management of patients who undergone a kidney transplantation in order to personalize the immunosuppressant treatment. We have confirmed the statistically significant correlation between the results of the IMBG and the clinical evolution of the transplanted patient, positioning IMBG as a promising tool to personalize and better adjust medical treatment in renal transplantation patients.
The study has shown that a bad clinical evolution (defined by a renal function deterioration and objective signs of immunological rejection) is significantly associated with a higher resistance profile to the IMs that the patient is taking according to the IMBG assay. On the contrary, those patients with a good clinical outcome are significantly associated with a more sensitivity profile to the drugs they take, confirmed in the IMBG assay. Therefore, we have established that the sensitivity or resistance patient´s profile to the immunosuppressant drugs, determined by IMBG assay, can be a relevant factor for the clinical prognosis of kidney transplanted patients.
Finally, the TRANSBIO clinical study have validated IMBG test performance and reproducibility. The interpretation of the IMBG test results has been automatized and standardized to be processed by the IMBG analysis software. IMBG results are later validated under an expert evaluation by an immunology specialist.
After these promising results, we are finalizing the optimization of the IMBG test, and we expect to obtain ISO13485 certification and finish IMBG European regulatory pathway in 2020.