MPE announces partnership with an international team, including representatives from scientific, industry, and healthcare sectors, as part of the EU-funded research project CERTAINTY, which began in December 2023. The EU consortium “CERTAINTY – A cellular immunotherapy virtual twin for personalized cancer treatment” is being funded by the European Union with almost EUR 10 million over the next 4.5 years within the Horizon Health 2023 program. The project, led by the Fraunhofer Institute for Cell Therapy and Immunology IZI, aims to develop a “virtual twin” that will improve treatment with personalised cancer immunotherapies in the future.

In recent years, cancer immunotherapies have established themselves as a further pillar of medical oncology alongside traditional treatment options (surgery, radiotherapy and chemotherapy). The advantages of personalized treatment approaches, such as CAR-T cell therapy, also include more precise phenotyping of individual patients.

Numerous clinical, imaging, molecular and cell analytical data are collected and processed for each patient for diagnosis, treatment decisions and follow-up. The totality of all patient data within a clinical picture harbors enormous potential for improving diagnosis and therapy for future patients. One approach to realizing this potential is the concept of the virtual twin. This involves merging certain molecular and cellular characteristics of a person and their clinical progression data into a digital representation, which is regularly updated using a series of data variables. Based on comparative data from patients with similar characteristics, the virtual twin can then be used to simulate prognoses regarding the course of the disease or various treatment options.

Corresponding concepts for virtual twins and the first promising models already exist in the field of cardiovascular diseases. In the EU project CERTAINTY, modules are now to be developed for a corresponding virtual twin for the treatment of cancer patients with CAR-T cell therapies. This will support doctors in selecting the best possible therapy in the future and also relieve the burden on the healthcare system through the more efficient use of cost-intensive drugs.

The virtual twin will initially be developed as an example for myeloma, a malignant disease of the bone marrow. The plan is for it to comprehensively reflect the individual pathophysiology of patients who are eligible for or undergoing cellular immunotherapies and to be updated regularly. A particular focus is on the integration of molecular patterns into the digital representation. Other key technologies include the collection and processing of large amounts of data (big data processing), machine learning, personalized in vitro models and software-supported mechanistic models. Another focus of work is the development of interfaces that ensure data access and interaction between different physical and digital systems, always taking data protection into account.

Other aspects taken into account in the project are the integration of socio-economic factors that can influence the course of the disease, as well as future applications for patients.

MPE will bring the patient perspective in the development of the virtual twin concept for CAR-T cell therapy in myeloma.

In CERTAINTY, MPE will have an advisory role regarding ethics (what data will be used, how it will be collected, how patients consent to it, how patients feel about sharing genetic data etc.) and data management (how the data will be stored, exploited, shared, and made accessible). MPE will investigate and share patient needs and concerns about virtual twins as well as their perspectives on automated stratification of patients based on CAR T-cell therapy eligibility criteria.

In addition, MPE will be involved in the database conceptual design. MPE will recruit a patient group to participate in a pilot study, which will be involved in the testing phase and will validate the real-world settings and user interfaces. The pilot study will also explore quality-of-life data and MPE will co-design research questions.

MPE will develop lay summaries, filmed interviews and other educational materials for the patient community. Patient perspectives will be integrated throughout the project by MPE. MPE believes this project will facilitate future treatment decisions and improve access to immunotherapies.

Find out about other EU projects MPE is involved in here.