Cynvenio and ATGen Open Recruitment for New LiquidBiopsy Clinical Research Study in Triple Negative Breast Cancer

New trial is open to patients who have completed standard treatments; Goal is to determine if cancer recurrences can be detected earlier and lead to improved targeted outcomes.

LOS ANGELES, December 28, 2015 – Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling the new era of individualized medicine for all cancer patients and ATGen Global, a Korea-based biotech company, today announced the launch of a pilot study to evaluate a new method for early detection of cancer in women who have completed treatment for triple-negative breast cancer (TNBC) and show no radiographic signs of metastases.

Of the estimated 1 million cases of breast cancer diagnosed annually worldwide, some 170,000 or more will have the TNBC subtype, which means these women test negative for estrogen receptor, progesterone receptor, and Her-2 receptor gene expression. Despite a relatively favorable response rate to chemotherapy, TNBC-classified patients are more likely to develop distant recurrence and die from breast cancer within five years of diagnosis compared with other patients, and one-third of all triple-negative patients will eventually develop metastatic disease.

The new study will use Cynvenio’s ClearID test based on its LiquidBiopsy® technology in combination with the NK Vue blood test from ATGen. The NK Vue test monitors the immune system – specifically the presence of natural killer (NK) cells – and can be used as a tool for assessing changes in patients with conditions where innate NK cell activity has been shown to be reduced, such as in some types of cancer. There has been a strong correlation between low NK cell activity and increased presence of circulating tumor cells. In this study, patients who show low NK levels will receive further analysis with the ClearID test to molecularly characterize circulating tumor cell and cell-free DNA present in their blood for genetic alterations that may support specific treatment regimens.

“It is highly likely that some women will harbor subclinical metastatic disease that cannot yet be radiographically detected and for which no specific biomarker has been identified, but in whom circulating tumor cells can be found,” said Paul Y. Song, MD, Chief Medical Officer of Cynvenio and ATGen. “Using a combination of Cynvenio’s ClearID technology and ATGen’s NK Vue test we believe we may help find these cancerous cells well before they embed themselves in organs or bone, and then analyze them to identify specific targeted therapies in hopes of improving outcomes.”

While the role of circulating tumor cells in blood has been understood for some time and is a growing area of interest, existing methods to monitor them are laborious, inconsistent, and costly. “Our method is simple, reliable, and inexpensive, and is not limited like some blood tests to only cell-free DNA,” said André de Fusco, Cynvenio’s CEO. “Further, our technology provides information about cell surface markers and proteins in addition to genomic insights. Our ultimate goal is to bring a practical and effective diagnostic test that offers actionable advice to a population of at-risk women for whom there is currently no concrete way to monitor cancer-free existence.”

The trial will begin enrollment immediately at Cynvenio’s CLIA/CAP certified lab in Westlake Village and will be expanded to include academic medical centers in Chicago, New York, Pittsburgh in the first half of 2016.

More information about the trial is available at https://clinicaltrials.gov/show/NCT02639832. More information about Cynvenio is available at www.cynvenio.com.

About Cynvenio Biosystems, Inc.

Cynvenio is a commercial stage clinical diagnostics company that leverages its proprietary LiquidBiopsy® multi-template technology for the molecular characterization of tumor cells from a standard blood draw. Commercial labs and research institutions are powered by Cynvenio’s LiquidBiopsy platform, which includes automated instrumentation, consumables/reagents, patient sample kits, and bioinformatics for sequencing rare cell populations. Oncology practices and individual physicians can also access the LiquidBiopsy system with zero upfront investment by ordering the ClearID™ blood test from Cynvenio’s CLIA/CAP lab or its clinical partners. ClearID and LiquidBiopsy are cornerstones in the emerging field of genomic peripheral blood monitoring. They are used to rapidly assess patients’ evolving mutations in support of precision medicine strategies. ClearID is reimbursable in the United States.

Cynvenio is headquartered in Westlake Village, California (Los Angeles). For more information, please visit www.cynvenio.com and www.liquidbiopsy.com.

About ATGen

ATGen Global is a privately held biotech company that manufactures and supplies a broad array of novel proteins, peptides, and antibodies worldwide. ATGen’s proprietary stable protein technology has enabled the company to expand into the development of in vitro diagnostics. The company is also involved in the research and development of cutting edge therapeutics. ATGen is headquartered in Seoul, South Korea with additional offices in Montreal, Canada and Valencia, CA. More information is available at http://atgenglobal.com/home.

LiquidBiopsy® is a registered trademark and ClearID™ is a trademark of Cynvenio Biosystems, Inc.

NK Vue™ is a registered trademark of ATGen Ltd. (Seoul, Korea)