Cynvenio Biosystems, Inc. recognized the recent Triple Negative Breast Cancer Day by announcing the launch of a clinical trial in women with triple negative breast cancer (TNBC), a breast cancer subtype marked by negative estrogen-, progesterone-, and Her-2–receptor gene expression, that will evaluate the company’s non-invasive liquid biopsy technology to monitor patients and identify early metastasis. The pilot study is now recruiting participants with previously treated, non-metastatic TNBC.
Cynvenio Biosystems’ proprietary LiquidBiopsy is a multi-template technology for the molecular characterization of tumor cells from a standard blood draw.
“Currently there is no effective way to monitor women who have completed standard therapy for TNBC and who remain at high risk of recurrence and metastases,” Paul Y. Song, Cynvenio’s CMO, said in a press release. “Our LiquidBiopsy®-based solution, which uses a simple blood draw and includes monitoring a woman’s immune system for signs of cancer recurrence, may help find cancerous cells well before they embed themselves into organs or bone. These cells can then be analyzed to identify specific targeted therapies in hopes of improving outcomes.”
The trial, “A Pilot Surveillance Study to Monitor Natural Killer Cells and Circulating Tumor Cells in Previously Treated Non-metastatic Triple Negative Breast Cancer,” will use the company’s ClearID genomic test, powered by the LiquidBiopsy technology, in combination with ATGen Global’s NK Vue blood test. The NK Vue test screens the immune system, particularly for natural killer (NK) cells, and can be used to assess changes in patients where innate NK cell activity is reduced, as is the case with some types of cancer. In this study, patients with lower NK levels will receive further analysis with the ClearID test to molecularly characterize circulating tumor cells and cell-free DNA in their blood for genetic alterations that may indicate specific treatment regimens.
Of the estimated 1 million breast cancers diagnosed each year worldwide, about 170,000 will be of the TNBC subtype. TNBC patients respond relatively well to chemotherapy, but are at a higher risk of developing distant recurrence and of dying of their cancer within five years of diagnosis. One-third of all TNBC patients develop metastatic disease, the company said in the release, with younger women, African-Americans and Latinas being at highest risk.
“We strive to provide the highest quality breast care medically and technologically possible, so we are excited to be the first center in the country to participate in this cutting-edge research,” said Kristi Funk, MD, founder of the Pink Lotus Breast Center in California, a trial site. “The ‘watch and wait’ plan is not reassuring to our patients; therefore, our goal is to provide women a better method for monitoring their health, and hopefully, cancer-free existence.”
Added Cynvenio’s CEO, André de Fusco: “This trial is an important milestone for our company and for the field of breast cancer research. It represents the culmination of four years of intense bioengineering development and we are thrilled to support Drs. Funk and Song in their quest to change the patient monitoring paradigm. Most importantly we hope our work will lead to tangible improvements in the standard of care for triple negative breast cancer survivors.”
More information on this study, expected to finish in December 2019, is available through its clinical trials.gov link.