Abstract 1604: IMI CANCER-ID: Validation of novel blood-based biomarker technologies in clinical settings

Abstract

Abstract The Innovative Medicines Initiative (IMI) was launched in 2008 as a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). IMI aims to facilitate the collaboration of healthcare stakeholders such as academic and clinical researchers, pharmaceutical industry and small and medium-sized enterprises (SMEs) in Europe, in order to address key issues in drug development and patient access to innovative medicines. Tumor heterogeneity and the dynamic changes at the molecular level during disease progression make longitudinal monitoring of malignant disease highly desirable in order to choose the best treatment options and to monitor treatment efficacy. As access to tumor tissue is often the limiting factor and historic samples are not predictive for the current state of the disease, liquid biopsies are explored to support personalized treatment of cancer patients. The CANCER-ID consortium was established in 2014 and aims to validate technologies for blood-based biomarkers such as Circulating Tumor Cells (CTCs), circulating tumor DNA (ctDNA) and microRNAs (miRNAs) to determine the absence/presence of drug targets and to assess the response to treatment. To prove broader applicability and clinical utility of the consortium's technologies and protocols, the validated assays will be deployed in controlled clinical studies (TRACERx, NCT01888601; NVALT17, NTR4410; SPECTAlung, NCT02214134; patients under SoC treatment) in 1) Non-Small Cell Lung Cancer (NSCLC) and 2) anti-Her2-resistant metastatic breast cancer (Her2RMBC). CANCER-ID is a unique network of experts in the fields of tumor biology, biomarker development, clinical sciences and bioinformatics with a total indicative budget of 14 Mio €. The consortium joins forces of 16 academic groups (ten large clinical trial sites), 6 EFPIA companies, 1 multi-national diagnostics company, 5 SMEs with advanced technologies for CTC isolation or for complex data analysis and big data handling, and two non-profit organizations. In order to fully exploit the synergies created by CANCER-ID, regulatory agencies and patient advocacy groups are involved and invited to participate in the IMI project. Citation Format: Thomas Schlange, Thomas Krahn, Sabrina Pleier, Klaus Pantel, Leon WMM Terstappen, Barbara Baggiani. IMI CANCER-ID: Validation of novel blood-based biomarker technologies in clinical settings. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 1604. doi:10.1158/1538-7445.AM2015-1604