Clinical validation of the CD32b biomarker on the European market

Informacje na temat projektu

BI-MARK

Identyfikator umowy o grant: 673735

DOI 10.3030/673735

Projekt został zamknięty

Data podpisania przez KE 30 Kwietnia 2015

Data rozpoczęcia 1 Maja 2015

Data zakończenia 30 Września 2015

Finansowanie w ramach

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

Koszt całkowity € 71 429,00

Wkład UE € 50 000,00

Koordynowany przez

BIOINVENT INTERNATIONAL AB
Sweden

Cel

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.

Dziedzina nauki

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

Program(-y)

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

Temat(-y)

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

Zaproszenie do składania wniosków

H2020-SMEInst-2014-2015

Zobacz inne projekty w ramach tego zaproszenia

Szczegółowe działanie

H2020-SMEINST-1-2014

System finansowania

SME-1 - SME instrument phase 1

Koordynator

BIOINVENT INTERNATIONAL AB

• Wkład UE netto: € 50 000,00
• Adres: SOELVEGATAN 41 ; 22370 LUND ; Szwecja
• MŚP Organizacja określiła się jako MŚP (firma z sektora małych i średnich przedsiębiorstw) w czasie podpisania umowy o grant. Tak:
  Region
  Södra Sverige › Sydsverige › Skåne län
• Region: Södra Sverige › Sydsverige › Skåne län
• Rodzaj działalności: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Koszt całkowity: € 71 429,00