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Development and validation of a pan-cancer neutrophil biomarker test for predicting clinical benefit from immunotherapy based on flow cytometry analysis of blood samples

Project description

Blood test for immunotherapy outcome prediction

Immune checkpoint inhibitors are a form of immunotherapy used to activate the immune system against cancer. However, most patients do not respond, and predicting who will benefit remains a major clinical challenge. Current biomarker tests have limited accuracy and often require invasive tumour biopsies. The EIC-funded NeutroFlow project addresses this unmet need by developing a simple blood test that uses neutrophils as a novel predictive biomarker for immunotherapy response. The research team will optimise this neutrophil assay for point-of-care use and validate it in three medical centres. This minimally invasive test could guide treatment decisions across cancer types, improving immunotherapy outcomes while reducing toxicity and healthcare costs.

Objective

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.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-EIC - HORIZON EIC Grants

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Call for proposal

(opens in new window) HORIZON-EIC-2024-TRANSITION-01

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Coordinator

ONCOHOST
Net EU contribution
€ 1 254 999,00
Address
HAMELACHA 17
3057324 Binyamina
Israel
SME
Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
No data

Participants (4)