Community Research and Development Information Service - CORDIS

H2020

NO-META Report Summary

Project ID: 734950

Periodic Reporting for period 1 - NO-META (Feasibility study of a NOvel METAbolic liquid biopsy for cancer therapy monitoring)

Reporting period: 2016-08-01 to 2016-12-31

Summary of the context and overall objectives of the project

Recent developments within EU in the area of health-care, such as cuts in budgets and higher life expectancy, are pointing cancer and other chronic diseases as an economic and social challenge. Non-personalized treatments, such as chemotherapy, often have low efficacy and serious side-effects worsening patient's quality of life at high costs for the society. In addition, it is not possible to tailor in advance on the single patient the best dosage, duration and period, and monitoring afterwards. This uncertainty is caused by a lack of diagnostic technology and too little insight into the progression of the disease & the efficacy of the therapy. There is therefore a need for improved / earlier diagnosis of metastatic cancer, determining which patients are more likely to die from progression and recurrence of metastases, identification of patients having a greater chance of certain treatments benefit, real-time monitoring of therapy response and early detection of cancer recurrence. An existing biomarker in oncology is the number of a patient circulating tumor cells (CTC) in the peripheral blood, which have detached from the primary tumor or metastasis. While there are several companies trying to commercialize CTCs detection platforms, the application of this biomarker is not yet widespread in the clinic: there is only one FDA-approved technology, CellSearch® who knows weaknesses in the sensitivity / specificity (since it is limited to recognition of a restricted subtype of cancer cells), the cost per analysis and limitations on further analysis of selected cells (these in fact are not extracted individually, are labeled and not vital). New methods are under development, but our methodology (selection based on cell behavior, ie the cell metabolism) is radically different and has never been explored, giving us the expectation to address the deficiencies of other techniques. Therefore CytoFind objective is to develop a diagnostic device for CTC enumeration and isolation, based on our new patented technology. The proposed method should lead to an overall improvement of the oncology care cycle through improved therapy selection (a reduction in the number of unnecessary treatments) and personalization, monitoring of therapy’s effects (better outcomes, improved quality of life patients and lower costs through a reduction in hospitalizations), and early detection of recurrences.
The objective of this project has been to investigate the economic feasibility of the proposed innovation and the preparation of a business plan to develop a new in vitro diagnostic test in order to detect cancer cells in the blood, help the clinician in the selection of the best therapy and give a rapid and robust feedback to monitor the effectiveness of therapy. The method makes use of the fact that tumor cells exhibit a different metabolism, which makes them secrete significantly higher amounts of lactate (lactic acid) and other acidic products than normal cells. This approach, that is linked to the gold standard for the detection of malignancy in tissues (PET, positron emission tomography), has never taken into account at the single cell level. The proposed technology screens for individual cells in a blood sample and can determine, by measuring the degree of acidity, if a cell is abnormal (tumoral). The cells can then be isolated and extracted for further analysis (such as immunostaining, detection of genetic mutations or DNA-RNA sequencing for the detection of clinically relevant features), thus greatly improving the diagnosis, care and treatment of cancer, which leads to a higher quality of life for the patient, with fewer unnecessary surgeries, personalized diagnosis and treatment, and better understanding of aftercare and development of the disease after treatment. Also, the living tumor cells may be analyzed, which leads to more insight into the stage of the disease, and the development of cancer as a disease in general.

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

To examine and assess the feasibility of the project, several areas have been examined:
- Technical: determine analytical validity of a prototype, reliability, accuracy, efficacy.
- Economic: define the best market introduction and its economic requirements, identification / quantification of the anticipated benefits, cost / benefit analysis.
- Market: examine competitors, competitive advantage and value proposition. Interviews with users (oncologists) and customers (management of hospitals / wards) have been conducted in several cases.

The new knowledge and insights have been used from this feasibility project to:
- assess the current business model, improve and expand.
- provide more insight into the risks and opportunities of the pre-commercial R & D phase.
- a Go / No Go decision to support to invest in the development and construction of a commercial application based on the technology and the implementation of the business model.

The work ended in the writing of a Business Plan; the business plan also includes an initial regulatory & claims planning in the context of in vitro diagnostics, the requirements necessary for approval and reimbursement, and required clinical studies.

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)

In the US, only one technologically similar competitor is certified, CellSearch®. However, this method fails in accuracy, affordability and functionality and to date, it has reached no large-scale clinical application in any country. Several other competitors are working on alternative solutions - both in academia as well as in startups and corporates, but all known efforts are characterized by their method being based either on physical properties, or on protein marker properties. Both methodologies have inherent limitations in sensitivity, accuracy and isolation capability at low cost. Our project is unique in using a different approach: cellular metabolism. We expect that with our methodology we can overcome the inherent limitations of existing approaches. We aim to develop a platform for broad clinical applications in cancer diagnosis, therapy selection, monitoring and follow-up, for several types of cancer. Overall, our method has a number of advantages over the current state of technology: the simplicity of a blood sample in comparison to an invasive procedure, as a biopsy, and the consequent possibility to take off a sample of blood to gain insight into the progression of the disease, the efficacy of the treatment phase and early detection of recurrence. Since CTCs circulate through the blood, they provide a sample from multiple tumor sites and metastases, giving a broad 'landscape' of the heterogeneity of the disease, in contrast to actual pre-therapy approaches based on biopsy of the primary tumor: the genetic profile of CTCs from a metastatic patient will give to the clinician information from metastatic sites so to evaluate the genetic stages of metastasis, the pharmacoresistance and suggest the best therapeutic approach for the single patient. CTCs can also be detected in blood of patients who are no longer clinically ill, in the case undetectable, metastatic sites still existing but too small to be detected by actual imaging methods.
A low cost, large-scalable diagnostic tool in oncology would represent a turning point in the cancer care, giving the best quality of life to patients at lower costs for the society: giving the most appropriate therapeutic approach at the right timing and dosage will improve life of the individual and reduce healthcare spending for society.

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