IOO: a novel assay to predict patient response to immune checkpoint inhibitors, optimising patient stratification to these therapies and tripling solid tumour patient outcomes in immuno-oncology.

Project Information

IOO - Improving IO

Grant agreement ID: 101161495

DOI

10.3030/101161495

EC signature date 6 May 2024

Start date 1 August 2024

End date 31 December 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 565 875,00

EU contribution

€ 2 496 112,50

Coordinated by

FASTBASE SOLUTIONS SOCIEDAD LIMITADA
Spain

Periodic Reporting for period 1 - IOO - Improving IO (IOO: a novel assay to predict patient response to immune checkpoint inhibitors, optimising patient stratification to these therapies and tripling solid tumour patient outcomes in immuno-oncology.)

Reporting period: 2024-08-01 to 2025-07-31

Summary of the context and overall objectives of the project

Immunotherapy is a beacon of hope in cancer's battle, but with a 10-20% response rate in solid tumors, its potential is untapped. Predicting patient responses to treatment, which current methods are ill-equipped for, is an urgent unmet medical need. Our project stands for industrializing our analytically validated multiplexed protein-function based biomarker assay (IOO), currently TRL6, which is based on our proprietary bio-imaging technology. Whilst scientifically validated, we need further clinical validation to obtain increased datasets required for regulatory certification for clinical deployment. This assay could triple the efficacy of currently available immune-oncology treatments by accurately predicting patient response to immune checkpoint inhibitors - the basis of 90% of current immuno-oncology therapies. If successful, we will bring this transformative solution to hospitals worldwide. The upshot could be game-changing: doubling survival rates for high-prevalence, lethal tumors like lung cancer.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

So far the work performed until M6 was most devoted to:
-WP1 and WP2: activties have been addressed mostly to the clinical protocol definition and the ethical committe approvals. Additionally, sample collection started with a slight delay with regards the original gantt chart. However, no impact is foreseen on the project development.Regarding the study performed under the WP1, it has been determinated that prospective samples are not required for CE marking therefore company is currently prioritazing the retrospective part of the study. Retrospective samples offer more reliable and efficient results. Additionally, the socio demographic impact of the study has been enriched including new countries and centers involved. For the clinical study performed under the WP2, benefiaciary has incorporated new types of tumor into the the study.
-WP4: T4.1 first version of IOO collaborative user cloud developed addressing: user usability, CE Mark regulation and quality requirements (as for ISO 13485 and ISO27001). Deliverable D4.1 submitted on time.
-WP6: activities have started in relation with the CE mark application and the obtention of IVD manufacture license (mandatory under national law as set by the AEMPS). Currently, the implementation of the QSM has been reach ed around the 80%. For the USA market, company has started the evaulation of the 510k application with the FDA.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Expected Results of the IOO Project Beyond the State of the Art

1. Enhanced Patient Stratification & Treatment Outcomes

- More precise identification of lung cancer patients who will benefit from PD-1/PD-L1 inhibitors.
- Reduction of misdiagnosis, ensuring that approximately 230,000 patients per year in Europe receive the most suitable first-line treatment.
- Potential 280% increase in the efficacy of current IO-ICI therapies, tripling patient response rates.
- Potential doubling of long-term survival rates for lung cancer patients.

2. Healthcare System Optimization & Cost Reduction

- More efficient allocation of immune-oncology (IO) treatments, preventing unnecessary or ineffective therapies.
- Estimated savings of €2.1 billion per year for European healthcare systems, equivalent to €24,000 per treated patient annually.
- Contribution to the sustainability of healthcare systems by reducing costs associated with ineffective treatments.

3.Global Impact & Leadership in Personalized Medicine

- Strengthening Europe’s position in the companion diagnostics and personalized medicine sector.
- Enabling a European deep-tech firm to compete in a market dominated by U.S.-based companies.
- Paving the way for broader adoption of precision medicine in oncology worldwide.

4.Economic Growth & Job Creation

- 115 new jobs created by 2030, primarily in healthcare, R&D, and medical device manufacturing.
- Stimulating economic activity in the biotech and medtech sectors.
- Encouraging further investment and innovation in immune-oncology and companion diagnostics.