Objective The overall objective of the proposed project is the clinical validation of a novel biomarker for B-cell malignancies. The presently most widely used anti-CD20 antibody treatment rituximab has considerably improved treatment options for patients with B-cell malignancies. However, effectiveness is limited by resistance to rituximab and reduced response on repeated treatments. Data indicates that tumor expression of CD32b is directly involved in the development of resistance to rituximab. CD32b has the potential to be used as predictive biomarker for critical clinical decisions for rituximab and related treatments, and will impact payers and patients. In addition, our company is developing a novel treatment – BI-1206 that specifically targets CD32b and significantly improves antitumor effects of rituximab alone. As such, the CD32b biomarker assay has the additional potential to become a companion diagnostic for BI-1206 and other future B-cell malignancy treatments. Our company and the affiliated research team have developed a flow cytometry assay for the detection of the CD32b receptor on tumor cells. The assay has been partially validated in a clinically relevant setting to demonstrate CD32b as a predicative biomarker of therapy response. To achieve market uptake of our technology, we aim to conduct a number of studies together with selected clinical partners in Europe. The objectives of the feasibility study are to find and contact researchers/clinicians for conducting retrospective and/or prospective studies, as well as to refine the business model for the commercialization of the biomarker assay. The intended users of our product are clinicians and therapy developers that focus on B-cell malignancies. By clinically validating a biomarker assay for B-cell malignancies and especially CLL, our company addresses an unmet European and global need for improved treatments for CLL, and B-cell malignancies in general. Fields of science social scienceseconomics and businessbusiness and managementbusiness models Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Call for proposal H2020-SMEInst-2014-2015 See other projects for this call Sub call H2020-SMEINST-1-2014 Funding Scheme SME-1 - SME instrument phase 1 Coordinator BIOINVENT INTERNATIONAL AB Net EU contribution € 50 000,00 Address SOELVEGATAN 41 22370 LUND Sweden See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Södra Sverige Sydsverige Skåne län Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 71 429,00
