In December 2023, an international team in which UNamur is actively involved through the Centre de Recherche Information, Droit et Société (CRIDS) and Professor Jean-Marc Van Gyseghem, launched the groundbreaking research project entitled "CERTAINTY - A cellular immunotherapy virtual twin for personalized cancer treatment". In collaboration with leading partners from science, industry and healthcare, this initiative led by the Fraunhofer Institute for Cell Therapy and Immunology (IZI) aims to shape a promising future for optimizing cancer treatment through the development of a virtual twin.

In cancer treatment, immunotherapies have emerged as an essential pillar in oncology alongside conventional treatments such as surgery, radiotherapy and chemotherapy. The CERTAINTY project focuses on the development of a virtual twin, an innovative advance aimed at improving treatment using immunotherapy. Led by the Fraunhofer Institute, the team is collaborating closely with global experts to realize this ambitious project.

Personalized immunotherapies, such as CAR-T cell therapy, enable more precise phenotyping (a genetic inventory) of each patient. Clinical, imaging, molecular and cellular data are collected and processed to personalize diagnosis, therapeutic decisions and follow-up. To fully exploit this potential, the concept of the virtual twin is introduced, merging molecular and cellular characteristics with clinical progression data in a constantly updated digital representation.

The virtual twin, initially developed for multiple myeloma, a bone marrow disease, aims to comprehensively reflect patients' individual pathophysiology. It will be used to simulate prognoses of disease progression and evaluate different treatment options. This groundbreaking project will not only help improve patient care, but also optimize the use of costly drugs, thus relieving the burden on the healthcare system.

CRIDS intervention

The Namur Digital Institute (NaDI) with its Centre de Recherche Information, Droit et Société(Crids) is the partner in charge of the project's compliance with the European regulatory framework, in particular aspects linked to (personal) data protection and the use of artificial intelligence tools. Alongside this legal dimension, Crids will also contribute its expertise in ethics. Its involvement will therefore be cross-functional and essential to the successful completion of the project, which will adopt a data protection and ethics methodology right from the design stage. CRIDS' involvement will enable us to adopt an all-encompassing approach to the legal issues associated with digital devices.

The substantial funding of almost 10 million euros over the next 4.5 years, awarded by the European Union, confirms CERTAINTY's strategic importance. The project also integrates legal and socio-economic aspects, considering their influence on disease progression, and explores future applications for patients. The development of key technologies such as megadata processing, machine learning, personalized in vitro models and software-supported mechanistic models represents a significant advance in medical research.

.

CERTAINTY thus marks a crucial step towards the advancement of cellular immunotherapy and demonstrates UNamur's commitment to innovative and transformative projects on a global scale as well as the CRIDS' recognition as a Center of Excellence.

CERTAINTY consortium members

Leader: Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.

Partners: Fraunhofer-Gesellschaft, Germany; University of Leipzig Medical Center, Germany; Singleron Biotechnologies GmbH, Germany; Collaborate Project Management, Germany; Myeloma Patients Europe AISBL, Belgium; TriNetX Oncology GmbH, Germany; Masaryk University, Czech Republic; Information Technology for Translational Medicine, Luxembourg; University Hospital Würzburg, Germany; Institut Curie, France; Centre de Recherche Information, Droit et Société (CRIDS), University of Namur, Belgium; Universitair Medisch Centrum (UMC) Utrecht, Netherlands; Charité - Universitätsmedizin Berlin, Germany; European Society for Blood and Marrow Transplantation (EBMT), Netherlands; HealthTree Foundation, USA; and Roche Pharma AG, Switzerland.

Funded by the European Union. The views and opinions expressed are, however, those of the authors and do not necessarily reflect those of the European Union. They do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible. Grant agreement 101136379.