BIOHOPE is developing a blood-based in vitro diagnosis device to personalize immunosuppressant therapy for patients under treatment with these drugs, such as kidney transplants, rheumatoid arthritis and many other immune-based conditions. This diagnostic kit been named Immunobiogram® (IMBG).
The preliminary data of the pilot study “BH-Pilot”, are already available, and the were presented at an investigator meeting with our Scientific Advisory Board held in the context of the European Society of Organ Transplantation (Barcelona, 24-27 September 2017).
The results observed to date with the INMUNOBIOGRAM®, obtained in blood samples from 35 kidney transplanted patients and 7 healthy volunteers as a control group, point to a positive proof of concept.
Only a conventional 10mL blood sample from the patient is needed to run the bioassay. It is based on PBMCs 3D culture in semi-solid matrix submitted to specific stimulation which replicates antigen presentation. Inmunobiogram® mimics immune response in which PBMC replicate and expand (C+), and this response is compared with no stimulation (C-) and with stimulation in presence of immunosuppressants (C+ with IMs). The output is a personalized comparative efficacy evaluation for each patient of those immunosuppressant most used in the clinical setting and their combinations. The bioassay uses pre-charged immunosuppressants according to clinical guidelines, but it can be adapted for testing new compounds against marketed ones. IMBG allows for a direct comparison between several immunosuppressant drugs and combinations in terms of immunosuppressive efficacy in each specific patient. Due to its design and easy-to-read output, it is compatible with a Point of Care (PoC) device.
Inmunobiogram® has been developed for rejection of renal transplantation, but it can be adapted to rheumatoid arthritis and other immune-based conditions treated with immunosuppresants.
A first European patent has been presented in August 2016 and an expanded European patent has been presented in June 2017.