Clinical validation of the CD32b biomarker on the European market

Projektinformationen

BI-MARK

ID Finanzhilfevereinbarung: 673735

DOI 10.3030/673735

Projekt abgeschlossen

EK-Unterschriftsdatum 30 April 2015

Startdatum 1 Mai 2015

Enddatum 30 September 2015

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten € 71 429,00

EU-Beitrag € 50 000,00

Koordiniert durch

BIOINVENT INTERNATIONAL AB
Sweden

Ziel

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.

Wissenschaftliches Gebiet

• social sciences › economics and business › business and management › business models

Programm/Programme

• H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme
• H2020-EU.3.1.3. - Treating and managing disease

Thema/Themen

• PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices

Aufforderung zur Vorschlagseinreichung

H2020-SMEInst-2014-2015

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-SMEINST-1-2014

Finanzierungsplan

SME-1 - SME instrument phase 1

Koordinator

BIOINVENT INTERNATIONAL AB

• Netto-EU-Beitrag: € 50 000,00
• Adresse: SOELVEGATAN 41 ; 22370 LUND ; Schweden
• KMU Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen). Ja:
  Region
  Södra Sverige › Sydsverige › Skåne län
• Region: Södra Sverige › Sydsverige › Skåne län
• Aktivitätstyp: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Gesamtkosten: € 71 429,00