Early detection of tumor DNA in liquid biopsies as a biomarker of cancer recurrence

Projektinformationen

ONCOTECT

ID Finanzhilfevereinbarung: 866815

DOI

10.3030/866815

Projekt abgeschlossen

EK-Unterschriftsdatum 11 Mai 2019

Startdatum 1 Juni 2019

Enddatum 30 November 2019

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

CYCLOMICS BV
Netherlands

Periodic Reporting for period 1 - ONCOTECT (Early detection of tumor DNA in liquid biopsies as a biomarker of cancer recurrence)

Berichtszeitraum: 2019-06-01 bis 2019-11-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

Cyclomics BV is a Dutch start-up company with the ambition to disrupt the cancer diagnostics market with its proprietary circulating tumor (ct) DNA detection technology. Cyclomics has developed a ground-breaking sequencing methodology that enables reliable, fast and ultrasensitive detection of cancer recurrence from blood samples (liquid biopsies).

The first product, ONCOTECT, detects oncogenic mutations in the TP53 gene, and is developed for accurate and early detection of head and neck cancer (HNC) recurrence. Recurrent disease after initial remission is a main cause of cancer-related death. In HNC, radiological examination is the current standard in detecting cancer lesions, but is unable to reliably detect recurrence early on, leading to treatment delays and low survival rates. Integration of the ONCOTECT assay into routine clinical workflow is inexpensive and will provide faster time-to-results relative to competing sequencing methods.

The main objectives of this feasibility study were to obtain critical insight in Cyclomics’ commercialization strategy, including freedom to operate (FTO), user needs and regulatory requirements.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

To assess if Cyclomics can commercially roll-out ONCOTECT in Europe and in the US, a preliminary FTO analysis has been performed. Furthermore, interviews with Key Opinion Leaders in the field have been conducted to define user needs for the ONCOTECT technology. These user needs allowed the identification of critical product optimization requirements, which in part have been carried in parallel to this feasibility study and will be completed before 2021. Lastly, the regulatory strategy for ONCOTECT has been defined and finetuned for the most effective route to market.

In conclusion, the overall strategy of Cyclomics for the development and commercialization of ONCOTECT seems very feasible. In the short term, Cyclomics should aim to generate promising clinical data on the efficacy and safety of ONCOTECT, perform the specified optimization steps in line with the identified user needs, and ideally also provide data on the cost-effectiveness of ONCOTECT in parallel to the clinical trials. Furthermore, additional support regarding the regulatory pathway of ONCOTECT will be secured by expansion of the Cyclomics team.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

Recurrent disease after initial remission is a main cause of cancer death, warranting early detection as key to improving patient outcomes and quality of life. This need is particularly strong in HNC, where over 100,000 new cases arise every year in the EU. Radiological imaging is the current standard in detecting HNC recurrence, but suffers from low sensitivity and specificity, revealing relapsed tumor lesions only when they have progressed too far for curative treatment strategies.

Since 90% of HNC patients carry specific oncogenic DNA mutations in the TP53 gene, the first application of this novel technology in recurrent HNC presents a considerable market opportunity for ONCOTECT. After achieving clinical proof-of-concept in a cohort of 20 patients, Cyclomics will offer its technology for licensing to a diagnostics company to further develop ONCOTECT as an in vitro diagnostic kit. This kit will be brought to the market with the aim of enabling superior quality in diagnostic and clinical decision making. Future applications include monitoring of cancer treatment response and early screening programs, encompassing various genes and cancer types, with the potential to impact the full spectrum of cancer diagnostics.

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