
The recent introduction of cancer immunotherapy based on immune checkpoint inhibitors (ICIs) has revolutionised the treatment landscape for a broad range of cancer types. However, response to ICIs varies widely between patients, with the majority experiencing resistance to therapy. Moreover, the increasing use of these costly drugs coupled with management of ICI-related toxicities creates a substantial economic burden. Current biomarker tests for determining eligibility for ICIs have limited predictive performance, and many require invasive tumour biopsies. Thus, novel (and preferentially non-invasive) biomarkers for predicting ICI clinical benefit are desperately needed for better guiding clinical decisions. The NeutroFlow project directly addresses this unmet need. We build on comprehensive academic research describing a flow cytometry assay for measuring a novel predictive biomarker in the blood – Ly6Ehi neutrophil – that accurately predicts therapeutic benefit from ICIs, outperforming the approved PD-L1 biomarker. The NeutroFlow project aims to upgrade the research-level assay to an industry-level, point-of-care prototype test based on a kit comprised of an antibody panel for biomarker detection by standard flow cytometry (FC). Specifically, we will: (i) develop an FC assay according to clinical standards; (ii) develop and clinically validate a computational model that translates FC readout into a prediction of clinical benefit; (iii) evaluate analytical validity of the prototype across three medical centres (i.e., at the point-of-care); and (iv) prepare for future market introduction. The future product represents a minimally-invasive, simple, rapid, cost-effective test performed using standard hospital equipment. As a pan-cancer blood test for accurately predicting ICI therapeutic benefit, the product will potentially expand the benefit of ICIs to more patients, improve quality of life, limit the risk of ICI-related toxicities and reduce economic burden.
Europe still sees a quarter of the world's cancer cases each year, making cancer the second leading cause of death and illness in the region after cardiovascular diseases. Unless we take decisive action, lives lost to cancer in the EU are set to increase by more than 24% by 2035, making it the leading cause of death in the EU. Cross-border collaboration can address this challenge by combining data from various modalities and sources, extracting meaningful insights to deepen our understanding of cancer. However, ethical, legal, and national regulations, along with data access processes, including differing interpretations of the EU GDPR create significant hurdles. Technical interoperability issues across European cancer RIs, and patients' and citizens' rights to control who uses their personal information and for what purposes further complicate data sharing. The project will provide European researchers, SMEs, and innovators with a decentralized collaborative network, “UNCAN-CONNECT,” for cancer research. It consists of both technical components, a governance, compliance, and operational framework based on the UNCAN blueprint, with the goal of operationalizing it. The objective is to facilitate access to cancer data, promote open science, and revolutionize cancer research and treatment by co-creating an open-source federation of federations platform. It will be developed using specific use cases focused on six major cancer types: Paediatric, Lymphoid malignancies, Pancreatic cancer, Ovarian, Lung, and Prostate cancers and active collaboration with a diverse range of stakeholders, including researchers, SMEs, industrial end users, and citizens. It will build on existing European RIs such as BBMRI as well as initiatives like EOSC4CANCER, CanSERV, EUCAIM, to enable seamless storage, access, sharing, and processing of data across Member States and associated countries. This approach will foster interoperability and collaboration, accelerating progress in cancer research. This action is part of the Cancer Mission clusters of projects 'Understanding' established in 2022.
Coping with breast cancer more and more becomes a major socio-economic challenge not least due to its constantly increasing incidence in the developing world. There is a growing need for novel strategies to improve understanding and capacity to predict resilience of women to the variety of stressful experiences and practical challenges related to breast cancer. This is a necessary step toward efficient recovery through personalized interventions. BOUNCE will bring together modeling, medical, and social sciences experts to advance current knowledge on the dynamic nature of resilience as it relates to efficient recovery from breast cancer. BOUNCE will take into consideration clinical, cancer-related biological, lifestyle, and psychosocial parameters in order to predict individual resilience trajectories throughout the cancer continuum and eventually increase resilience in breast cancer survivors and help them remain in the workforce and enjoy a better quality of life. BOUNCE will deliver a unified clinical model of modifiable factors associated with optimal disease outcomes and will deploy a prospective multi-center clinical pilot at four major oncology centers (in Italy, Finland, Israel and Portugal), where a total of 660 women will be recruited in order to assess its clinical validity against crucial patient outcomes (illness progression, wellbeing, and functionality). The advanced computational tools to be employed will validate indices of patients’ capacity to bounce back during the highly stressful treatment and recovery period following diagnosis of breast cancer. The overreaching goal of BOUNCE is to incorporate elements of a dynamic, predictive model of patient outcomes in building a decision-support system used in routine clinical practice to provide physicians and other health professionals with concrete, personalized recommendations regarding optimal psychosocial support strategies.