BioMarker Strategies said today it has won a two-year, $1.98 million Phase II Fast Track Small Business Innovation Research (SBIR) grant from the NIH’s National Cancer Institute (NCI) toward development of a companion diagnostic test toward facilitating therapy selection for patients with non-small cell lung cancer.
PathMAP NSCLC is a companion diagnostic assay designed to provide information about the response of individual tumors to targeted treatments at the tumor cell signaling level, including resistance to therapy, using a patient’s live solid tumor cells. PathMap uses the company’s customizable, automated, fluidics-based SnapPath Cancer Diagnostics System, created to guide targeted drug development and treatment selection for patients with solid tumor cancers.
The company says PathMAP is the only cancer diagnostics system capable of automating and standardizing functional ex vivo profiling of live solid tumor cells from fresh biopsies or other fresh, unfixed samples such as xenografts or tumorgrafts.
PathMap generates functional signaling profiles intended to reveal information regarding signal transduction networks, including pathway activation and feedback loops, with the goal of predicting patient response to targeted drug therapy. The profiles are algorithm-based tests that compare stimulated and inhibited patient samples to unstimulated, basal samples.
According to BioMarker Strategies, the profiles use phosphoprotein-based ex vivo biomarkers to yield functional information beyond what can be achieved with traditional static DNA or RNA biomarkers in dead tissue.
PathMAP and its functional signaling profiles are available for use in preclinical studies in tumorgraft and other model systems, and in early clinical studies to assess pharmacodynamic changes in the solid tumors of individual patients, the company added.
Patents covering PathMAP Functional Signaling Profile technology have been granted in Europe, Australia, Japan, and Singapore. In the U.S., a patent has also been officially allowed and is proceeding to grant.
Based in Rockville, MD, BioMarker Strategies last year won a $225,000 Phase I SBIR grant toward supporting development of initial proof-of-concept data for the companion diagnostics test.
“The challenge for oncologists treating patients with non-small cell lung cancer is to determine which individual patients are most likely to benefit from which targeted therapy or combination of therapies,” Jerry Parrott, President and CEO of BioMarker Strategies, said in a statement. “The use of molecularly targeted agents such as the EGFR inhibitor erlotinib can help patients keep their cancer in check. However, for most patients, the emergence of resistance mechanisms ultimately results in the progression of disease.”