NCI grants Phase 2 SBIR contract to 20/20 GeneSystems

The funding will support the development and validation of a diagnostic test to determine the response of kidney cancer patients to anti-angiogenic therapy

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ROCKVILLE, Md.—20/20 GeneSystems, Inc., which develops and commercializes diagnostics test to aid in cancer treatment, has announced the receipt of a cost-sharing Phase 2 Small Business Innovation and Research contract from the National Cancer Institute of the National Institutes of Health. The contract will support the development, optimization and validation of a test that could help predict if a patient with advanced-stage renal cell carcinoma is likely to respond beneficially to anti-angiogenic therapy.
“There is a large unmet clinical need for an assay to identify kidney cancer patients likely to respond or not respond to a particular therapy. The early results which 20/20 presented last year are very promising. The 20/20 test would help guide treatment decisions and strategies so we can provide the best informed care to our patients,” Sandy Srinivas, M.D., associate professor of Oncology at the Stanford University School of Medicine, said in a press release. “There is a definite need for a companion diagnostic to predict response to anti-angiogenic drugs as there are other targeted therapies, with other mechanisms of action, which may be more suitable.”
Kidney cancer fails to exhibit any symptoms when in the early stages, making it difficult to detect until it is already at an advanced state, at which point it fails to respond to chemotherapy and radiation. Immunotherapy, anti-angiogenic agents and mTOR inhibitors are the standard treatment for advance renal cell carcinoma, but all tend to only be effective in a fraction of cancer patients. There were an estimated 65,000 new cases of renal cell carcinoma in the United States in 2013, with some 13,600 deaths attributed to the disease last year. Kidney cancer represents 3 percent of all cancers, and is the sixth leading cause of cancer death.
20/20 GeneSystems notes on its website that “Objective response rates to anti-angiogenic therapy (sunitinib) is 30 to 40 percent for sunitinib, and 10 percent for mTOR inhibitors (everolimu and temsirolimus). As both adverse reactions and treatment costs are significant, there is an unmet medical need for a method to identify responders and non-responders.” The company’s test is based on its Layered Immunohistochemistry technology, using “a single tissue section from a standard FFPE tissue block to measure the expression levels of key proteins in the VEGF and PI3K/AKT/mTOR pathways.”
“Anti-angiogenic therapy is typically the first choice of targeted therapy following cancer relapse after nephrectomy and in patients who present with Stage 4 cancer. mTOR inhibitors are normally used after failure of treatment with sunitinib or sorafenib,” 20/20 GeneSystems explained.
In related news, 20/20 GeneSystems presented data in early January at the 3rd annual American Association of Cancer Research IASLC Joint Conference on the Molecular Origins of Lung Cancer. The company shared a retrospective study of a multiplex immunoassay blood test that utilizes a panel of four tumor proteins and antibodies in order to determine the likelihood that non-small cell lung carcinoma is present in asymptomatic individuals.
SOURCE: 20/20 GeneSystems Inc. press release

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