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Clinical validation of the CD32b biomarker on the European market

Periodic Reporting for period 1 - BI-MARK (Clinical validation of the CD32b biomarker on the European market)

Reporting period: 2015-05-01 to 2015-09-30

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, resistance to rituximab and reduced response on repeated treatments limits effectiveness. Data indicates that tumor expression of CD32b is directly involved in the development of resistance to rituximab. In addition, our company is developing a novel treatment – BI-1206 that specifically targets CD32b and significantly improves antitumor effects of rituximab alone. It would be of interest to develop a biomarker assay that has the additional potential to become a companion diagnostic for BI-1206 and other future B-cell malignancy treatments.
The objectives of the feasibility study was 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.
All contacted clinicians expressed interest in the project. The key opinion leaders also agreed that any study should consist of at least two phases: first a small retrospective study to establish preliminary correlation, then a larger retro or prospective study. Based on the input and interest from contacted clinicians, a work plan for clinical studies with selected leading clinicians in Europe will be developed.
The feasibility study has also resulted in a deeper understanding of the CLL market, CLL treatment regimes, user needs, regulatory considerations and reimbursement of diagnostics. Based on this knowledge the business model has been refined and a more detailed business and commercialisation plan been developed.
The resulting business plan together with the work plan for clinical studies will form the base for a phase 2 SME-instrument application.
By clinically validating a biomarker assay for CLL our company addresses an unmet European and global need to improve treatments for CLL.
A robust clinically validated biomarker assay for CLL and rituximab treatment will provid clinicians with a clinical decision tool to effectively manage treatment and increase access to novel targeted treatments for patients. This will serve to improve patient outcomes and contribute to sustainability of the healthcare system in Europe and beyond.
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