ROCKVILLE, Md.--(BUSINESS WIRE)--BioMarker Strategies today announced that the journal CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS has published a manuscript by the Company’s scientists entitled “Functional Profiling of Head and Neck/Esophageal Squamous Cell Carcinoma to Predict Cetuximab Response”. The manuscript describes the company’s progress in identifying predictive dynamic biomarkers to help identify the subset of patients with head and neck/esophageal squamous cell carcinoma (SCC) who may benefit from treatment with cetuximab (Erbitux) and biosimilars.
Cetuximab is an antibody that targets an epidermal growth factor receptor (EGFR), and remains the only targeted therapy approved by the U.S. Food and Drug Administration (FDA) for SCC of head and neck/esophagus. For primary SCC, cetuximab is approved for use in combination with radiation. In metastatic SCC, it is approved for use in combination with platinum chemotherapy and fluorouracil.
The authors note that responses to cetuximab can be dramatic, but the response rate was only about 15% in the landmark clinical trial. The authors also note that cetuximab therapy is accompanied by a risk of serious adverse events that results in interrupted therapy in 3%-10% of patients. The cost of treatment is approximately $100,000 per patient. Additionally, immune checkpoint inhibitors are now an option in SCC. Therefore, methods to identify patients who are most likely to respond to cetuximab are needed.
SCC is the world’s sixth most common cancer. Worldwide, there are approximately 900,000 new cases and 450,000 deaths per year. In the United States alone there are approximately 66,630 new cases and 14,620 deaths per year.
“To minimize risk and maximize the therapeutic benefit of cetuximab, predictive tests to better identify patients likely to be responsive to cetuximab therapy are clearly an important need,” said Jerry Parrott, President and CEO of BioMarker Strategies. “From my perspective, based on the results reported here, I would agree with the authors that further studies are warranted to test in more complex samples, including patient-derived tumor tissues.”
The research described in the manuscript discussed here was supported by a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).
About BioMarker Strategies
BioMarker Strategies has developed SnapPath®, the only cancer diagnostics system that automates and standardizes functional ex vivo profiling of live solid tumor cells from fresh biopsies or other fresh, unfixed samples such as patient-derived xenografts. SnapPath® can help guide cancer drug development and treatment selection. SnapPath® is unique in automating and standardizing functional profiling of live solid tumor cells from fresh, unfixed tissue samples – and enables the generation of PathMAP® Functional Signaling Profiles.
PathMAP® Functional Signaling Profiles, such as the studies describe here, represent a new class of biomarker tests, which are based on the dynamic and predictive signaling information available only from live cells. They are useful in identifying and understanding mechanisms of acquired resistance, and they are highly predictive of individual tumor response to targeted therapies.
The information in this press release includes our projections and other forward-looking statements regarding future events. In some cases, forward-looking statements may be identified by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “projects,” “estimates,” “predicts,” “potential,” “continue”, etc. These statements are not guarantees of future performance or achievement and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is projected here.