AFFINERGY, LLC — Department of Health and Human Services SBIR Phase I: 400

Description

SUMMARY ABSTRACT Hepcidin is the peptide hormone responsible for regulating circulating iron concentrations Overexpression of hepcidin results in severe iron deficiency and anemia whereas hepcidin deficiency leads to iron overload Not surprisingly abnormalities in hepcidin production and circulating concentrations are highly correlated with various disease states such as renal disease cancer hereditary hemochromatosis hypoxia anemia of inflammation infection inflammatory diseases and heart disease Accurate methods for detecting hepcidin in serum will lead to improvements in our understanding diagnosis and clinical management of iron metabolism disorders Unfortunately there is no FDA approved assay for measuring hepcidin levels in plasma The development of a clinically relevant hepcidin assay has been hindered by hepcidin s very low immunogenicity making it extremely challenging to produce antibodies against the hormone The few immunoassays that do exist are poorly characterized in terms of specificity and they struggle to differentiate hepcidin from the multiple inactive forms of the hormone that are found in the circulation Affinergy plans to develop a phage based clinical chemistry assay that will enable frequent simple and affordable monitoring of plasma hepcidin levels Using our core technology of phage display biopanning we have already identified a proprietary capture peptide that binds to hepcidin In this Phase application we intend to identify a hepcidin specific detection phage and incorporate the hepcidin binding peptide and phage in a rapid easy to use sandwich ELISA based assay At the conclusion of Phase we expect to have a technology that can be scaled up in Phase for use by clinicians and researchers to measure hepcidin concentrations in plasma PROJECT NARRATIVE Hepcidin is the peptide hormone responsible for regulating circulating iron concentrations and abnormalities in hepcidin production and circulating concentrations are highly correlated with multiple disease states Unfortunately hepcidin has very low immunogenicity making it extremely challenging to develop antibodies or immunoassays for the hormone In this application we propose to develop a novel phage based sandwich assay to facilitate rapid and affordable measurement of hepcidin concentration in plasma