NEW YORK (GenomeWeb) – BioMarker Strategies has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute to develop a companion diagnostic to identify head and neck squamous cell carcinoma (HNSCC) patients most likely to benefit from Erbitux (cetuximab).
Erbitux is a monoclonal antibody inhibitor of epidermal growth factor receptor (EGFR) and is approved in the US for the treatment of HNSCC alone or in combination with radiation or platinum-based therapy, as well as for colorectal cancer and metastatic non-small cell lung cancer.
With the nine-month grant — worth $299,340 — BioMarker Strategies aims to develop a companion diagnostic that analyzes live tumor cells for pharmacodynamic responses of specific phosphoproteins in the MAPK, JAK/STAT, and PI3K pathways upon cetuximab exposure. The test will be based on the company's SnapPath platform, which is used for ex vivo profiling of live solid tumor cells from fresh, unfixed samples, and will incorporate its PathMap signal profiling technology.
The work will help determine percent suppression cutoff values for predictive biomarkers and confirm operationalization of the test in complex samples, BioMarker Strategies said in the grant's abstract. It will also determine the sample size for a future larger multisite sample collection for Phase II development.
"Cetuximab … is the most widely prescribed drug for the treatment of HNSCC," BioMarker Strategies President and CEO Jerry Parrott said in a statement. "Yet, the patient response rate to cetuximab based on the landmark clinical trial is only approximately 13 percent. There is a clear and urgent medical need for a companion diagnostic test to identify those patients with HNSCC who are most likely to respond to cetuximab."
Last year, BioMarker Strategies won a Phase II SBIR grant from the NCI worth $2 million to develop a companion diagnostic for non-small cell lung cancer therapies. The SnapPath platform was also developed with $2.3 million in NCI SBIR grant funding.