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Liquid Biopsy Propelling Cancer Diagnostics Research Is Focus of Mid-Morning Session on Day 2 of Personalized Medicine World Conference (PMWC) 2017 at Duke; GRAIL Founder Richard Klausner Speaks

Speakers in the mid-morning session of Day 2 of the PMWC 2017 at Duke focused on how “Liquid Biopsy Is Propelling Cancer Diagnostics Research.” The speakers included Richard Klausner, MD, former Director of the National Cancer Institute, past Chief Medical Officer at Illumina, and a founder of GRAIL, Inc. (https://grail.com/), a life sciences company whose mission is to detect cancer early, when it can be cured, using wide and deep DNA sequencing analysis of circulating cell-free DNA (cfDNA); John Beeler, PhD, VP of Corporate & Business Development, Inivata (https://www.inivata.com/), a company dedicated to transforming clinical cancer care with liquid biopsy; and Edward Kim, MD, Chair of Solid Tumor Oncology and Investigational Therapeutics and the Donald S. Kim Distinguished Chair for Cancer Research at the Levine Cancer Institute, Carolinas HealthCare System in Charlotte, North Carolina. Dr. Kim was previously at UT MD Anderson Cancer Center in Houston, Texas where he was a tenured Associate Professor of Medicine, Chief of the Section of Head and Neck Medical Oncology, and Director of Clinical Research Operations in the Department of Thoracic/Head and Neck Medical Oncology. Dr. Klausner began the session by briefly telling the story of how GRAIL, a company that recently raised $900 million in funding, came to be. The story began not too long ago at Illumina, the biotech company where Dr. Klausner was CMO. Illumina had developed a highly specific and precise liquid biopsy test (Noninvasive Prenatal Testing) that could detect aberrant chromosome numbers (monosomies and trisomies) in fetal DNA in blood taken from expectant mothers as early as 10 weeks into the pregnancy. Dr. Klausner said that this test became the most rapidly adopted test in history. But additional important news was to come. In the testing of 150,000 apparently healthy young expectant mothers with the NIPT test, 15 of the women showed chromosome abnormalities associated with cancer. Illumina tracked down 14 of these 15 women and it was determined that they did, in fact, have cancer. This suggested that such testing might point to a way to identify cancer at a very early stage, when the possibility of a cure is higher, and it was on this idea that GRAIL was founded and th goal it is now striving toward. Dr. Klausner also noted that the GRAIL will likely teach us much about early cancer and its kinetics, about which we know very little now, and may reveal new ways to intervene effectively in cancers.

Dr. Beeler of Inivata noted the recent funding of GRAIL ($900 million) and Guardant ($300 million) as indicators of the great potential of liquid biopsies. Inivata believes that its liquid biopsys platform is best in class and offers the ability to detect and characterize circulation tumor DNA (ctDNA) via a simple blood test. The company’s goal is to enable healthcare professionals to continuously monitor and adapt their patient’s treatment, personalizing cancer care. The Inivata platform brings together NGS with proprietary algorithms and databases that correlate genetic profiles to clinical outcomes. The intent is to provide clinicians the opportunity to better stratify patients, make more informed therapy decisions, and closely monitor treatment progress—enabling a potential revolution in precision cancer genomics.

Dr. Kim, of the Levine Cancer Institute (LCI) that has more than 25 cancer care locations across the Carolinas, said that liquid biopsy of circulating tumor DNA (ctDNA) will be the “next big innovation in cancer care.” He briefly described the Targeted Agent and Profiling Utilization Registry (TAPUR) study (https://www.tapur.org/) and noted that the LCI leads the country in enrollment in TAPUR. The TAPUR study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. The study provides approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies, catalogues the choice of genomic profiling test by clinical oncologists, and aims to learn about the utility of registry data to develop hypotheses for additional clinical trials. Dr. Kim also emphasized the advantages of having patients enrolled in clinical trials near their homes.

[PMWC 2017 Duke]