Cynvenio Biosystems, Inc. announced that the National Cancer Institute (NCI) awarded two Small Business Innovative Research (SBIR) contracts to develop novel lung cancer tests based on the isolation of mutation-bearing Circulating Tumor Cells (CTCs) from whole blood. The NCI awarded Phase I funding of $195,000 for each contract, and Cynvenio will be eligible to apply for Phase II funding of $1.5 million (for each contract) when the Phase I objectives are successfully achieved. Cynvenio's core technology was independently verified against clinical patient samples in 2011. The company also announced that it has received an additional $1.2 million from existing shareholders as part of a fully committed $2.0 million financing authorized by its board of directors.
For the first contract, Cynvenio will use the funding from the SBIR and its investors to develop a Liquid Biopsy(TM) blood test, and a companion diagnostic device that isolates CTCs from the peripheral blood of lung cancer patients in order to identify the DNA mutations associated with each individual's disease. Improvement of treatment outcomes for cancer patients with solid tissue tumors depends on the drug's ability to target the genetic mutations responsible for tumor growth. Currently, mutational analysis requires an invasive tissue biopsy, which is clinically impractical to perform repeatedly over time for longitudinal studies. As an alternative, extracting CTCs - cancer cells released into the bloodstream by the primary tumor - for molecular analysis offers an attractive strategy for genotyping patient-specific tumors and mutations.
For the second contract Cynvenio will use the funding from the SBIR and its investors to develop a CTC-based test to measure resistance to drugs in lung cancer patients. The evolving understanding of cancer indicates that every tumor has distinct characteristics driven by the molecular pathology of the disease. Predicted by this heterogeneity, targeted therapeutic agents are much more successful than a "one size fits all" approach. Currently, there are no tools to analyze resistance in solid tissue tumor cells other than a traditional biopsy. This limitation typically precludes testing for molecular markers that emerge during treatment. Cynvenio's goal is to develop and characterize a CTC-based molecular drug resistance test and demonstrate application in clinical samples. 15-20% of non-small cell lung cancers are driven by activating mutations in the epidermal growth factor receptor (EGFR), a mutation that can be very effectively treated with EGFR inhibitors such as gefitinib and erlotinib. Resistance to these drugs arises universally, caused half of the time by a T790M mutation. Currently, resistance is determined medically by demonstrating tumor progression. As an alternative approach, extracting the small number of CTCs released into the bloodstream for detection of the emergence of the T790M mutation offers a strategy for genotyping patient-specific tumor cells in real time. This will produce a fundamentally enabling technology for predictive cancer tests in personalized medicine.
"We are extremely pleased the NCI has awarded this funding which will allow Cynvenio and our clinical collaborators to accelerate our validation programs aimed at harnessing the DNA of mutation-bearing Circulating Tumor Cells in lung cancer patients," said Andre de Fusco, Cynvenio's CEO. "The NCI awards reflect a growing recognition that CTCs are central to the longitudinal testing of cancer patients and the implementation of personalized medicine models. We look forward to addressing all solid tissue tumor disease models in the future as we secure incremental funding for the LiquidBiopsy(TM) program."