Blood-based biomarkers such as circulating tumor cells (CTCs), circulating free DNA (cfDNA), circulating tumor DNA (ctDNA) and microRNAs (miRNAs) are potential indicators for the tumor burden of patients living with cancer. Identification and analysis of these markers from blood is still exploratory, but they may offer an additional and extremely useful tool for modern anti-cancer therapy. Blood based tests are not only very useful when biopsies of the tumor are not feasible (i.e., limited access to tumor, etc.), but also such blood-based tests may allow a close follow-up, and thereby offer a way to monitor the efficacy of treatment and potentially improve the choice of treatment options.
CANCER-ID is a newly formed European consortium funded by the Innovative Medicines Initiative (IMI) with currently 33 partners from 13 countries with the common goal of establishing standard protocols for clinical validation of blood-based biomarkers. In this unique setting, experts from all walks of cancer clinical research, e.g. academic and clinical research, innovative Small-to-Medium sized Enterprises (SMEs), diagnostics companies, and the pharmaceutical industry, will work together to establish the clinical utility of “liquid biopsies” in patients with Non-Small Cell Lung Cancer or Her2-therapy resistant breast cancer. The consortium’s industrial partners are currently contributing 8.2 million € to the project, and these funds are complemented the IMI Joint Undertaking for a combined 14.5 million € budget.
“Blood-based analyses of tumor derived cells and nucleic acids offer a novel concept of liquid biopsies which allows real-time information relevant to cancer diagnosis and therapy. The CANCER-ID project fills the substantial gap between basic research focused on novel methods for the detection and characterization of circulating tumor cells and nucleic acids and the development of robust validated assays required to bring the liquid biopsy concept into the clinic”, says Prof. Klaus Pantel from the University Medical Center Hamburg-Eppendorf and one of the academic leads of the CANCER-ID consortium.
The EORTC is contributing to this project through its SPECTAlung platform.
SPECTAlung, Screening Patients with thoracic tumors for Efficient Clinical Trial Access, is a screening program of the EORTC in collaboration with the European Thoracic Oncology Platform (ETOP) for efficient clinical trial access for patients with thoracic tumors. It is the first European standardized, quality-assured molecular testing platform for thoracic tumor characterization with the overall goal of offering to patients specifically targeted downstream clinical trials.
Dr. Jessica Menis, EORTC Clinical Research Physician, says, “The SPECTAlung study design already includes a thorough analysis of tissue as well as blood draws and pleural effusion for biomarker analysis, and this makes these ideal for the validation of blood borne biomarker studies for Cancer ID. Eligible patients will be those having a pathological diagnosis of any thoracic tumor (lung cancer, malignant pleural mesothelioma and thymic malignancies) at any stage of disease evolution.”
Bayer HealthCare and Silicon Biosystems, A Menarini Group Company, are the EFPIA lead companies of the CANCER-ID consortium. “CANCER-ID is an excellent example of a project in which a public-private partnerships enables a collaborative research approach to come up with novel concepts in modern cancer therapy”, says Dr. Thomas Schlange from Global Biomarker Research at Bayer HealthCare Global Drug Discovery. “The consortium brings together a large experienced team of biomarker experts from all over Europe that extends far beyond the scope of traditional ‘one-on-one’ industry-academia collaborations.”
About the Innovative Medicines Initiative (IMI)
IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU’s research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects ‘in kind’, for example by donating their researchers’ time or providing access to research facilities or resources.
The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° , resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.