Pulmokine, Inc. has been awarded a National Institute of Health Phase I Small Business Innovation Research (SBIR) grant worth $515,000 entitled “A Phosphopeptide Multiplex PRM Mass Spectroscopic Biomarker Assay For PAH” . Pulmokine, Inc. is a privately held biopharmaceutical company focusing on pulmonary disease and kinase inhibitor technology. The company’s mission is to develop new ways of treating hard-to-treat lung conditions and pulmonary arterial hypertension (PAH) and related disorders.
The grant Pulmokine, Inc. has been awarded is for the SBIR project to develop a quantitative phosphopeptide biomarker assay for pulmonary arterial hypertension (PAH). It will consist of a kit of stable isotopically labeled internal standards of a selected set of phosphopeptides either up or down-regulated in PAH. The set of stable isotopically labeled peptides will be used to quantify the level of target phosphoproteins in the buffy coat fraction of blood in a parallel reaction monitoring (PRM) mass spectroscopy (MS) assay.
The company proposes to determine if a subset of these phosphoproteins are differentially regulated in peripheral blood mononuclear cells (PBMCs) (buffy coat, which contains lymphocytes and platelets) of subjects with PAH compared to controls, to develop assays that can be used to determine how the levels of these phosphoproteins change over time, and to determine if these levels correlate with clinically important endpoints: i.e., mortality risk, hospitalization for PAH, and listing for lung transplant.
Phase 2 of the project will address regulatory requirements for kit commercialization, provide a longer validation study, and perform serial sampling of subjects with iPAH to correlate biomarker results with clinical course and prognosis.