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Clinical validation of the CD32b biomarker on the European market

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 (EuroSciVoc)

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Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

SME-1 - SME instrument phase 1

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-SMEInst-2014-2015

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Coordinator

BIOINVENT INTERNATIONAL AB
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 50 000,00
Address
SOELVEGATAN 41
22370 LUND
Sweden

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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
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 71 429,00
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