Cambridge Epigenetix has launched a discovery and development program for a test to detect colorectal and other cancers, using proceeds from a just-completed $30 million financing round and exclusive patent rights the company has acquired for its epigenetic sequencing platform.

The company is developing a detection test for colorectal cancer (CRC) using proprietary technology for analyzing epigenetic modification 5-hydroxymethylcytosine (5hmC) in circulating free DNA (cfDNA).

Development of the diagnostic test will be overseen by the company’s newly-appointed CEO, Suman Shirodkar, MBBS, PhD. Before joining Cambridge Epigenetix, Dr. Shirodkar led product teams in oncology, HIV, and cardiovascular medicine at Pfizer and Novartis.

“Our ability to detect 5hmC in circulating, cell-free DNA, and the discovery and development of a liquid biopsy signature for tumors, could revolutionize cancer care and decrease cancer mortality through widespread screening, early detection and timely intervention,” Dr. Shirodkar stated Tuesday. “I am excited to lead the talented team at Cambridge Epigenetix for the development and launch of the first of many tests to detect cancer.”

Cambridge Epigenetix said it is conducting a discovery study with over 2,000 patient samples, including healthy volunteers, and individuals with adenomas and all stages of CRC. The study followed what the company said were encouraging preliminary results from profiling 5hmC in over 200 CRC and healthy volunteer cfDNA samples.

“Cambridge Epigenetix’s 5hmC platform analyses some of the earliest markers of cancer development in patients’ blood samples to detect disease. Ultimately, our aim is to develop a diagnostic test that can detect multiple cancers from one standard blood draw,” the company said in a statement from co-founder Sir Shankar Balasubramanian, FRS, FMedSci, and Herchel Smith, PhD, professor of medicinal chemistry at the University of Cambridge.

The 5hmC platform is designed to enable sensitive and specific detection of epigenetic biomarkers for cancer in blood and other liquid biopsy samples.

To advance that platform, Cambridge Epigenetix has completed the $30 million round of secured funding led by Ahren Innovation Capital, with existing investors GV (formerly Google Ventures), New Sciences Ventures, and Sequoia Capital being joined by new investors that included DNA Capital Brazil.

The latest financing brings the total amount of capital raised Cambridge Epigenetix since its founding to $56.5 million.

Cambridge Epigenetix cited a pair of 2017 studies indicating that the measurement of 5hmC in plasma circulating cfDNA is effective for non-invasive cancer detection. A study  published September 19, 2017 in Cell Researchcompared normal tissues from 90 healthy individuals with paired tumor and adjacent tissues collected from a cohort of 260 patients recently diagnosed with colorectal, gastric, pancreatic, liver or thyroid cancer, using genome-wide profiling of 5hmC in circulating cfDNA and in genomic DNA (gDNA).

“5hmC-based biomarkers of circulating cfDNA were highly predictive of colorectal and gastric cancers and were superior to conventional biomarkers and comparable to 5hmC biomarkers from tissue biopsies,” the study found. “This new strategy could lead to the development of effective, minimally invasive methods for diagnosis and prognosis of cancer from the analyses of blood samples.”

A month earlier, in another study published in Cell Research, a research team presented proof-of-principle results that they concluded “suggest that cell-free 5hmC signatures may potentially be used not only to identify cancer types but also to track tumor stage in some cancers.”

Those researchers sequenced cell-free 5hmC from 49 patients of seven different cancer types, finding distinct features that could be used to predict cancer types and stages with high accuracy.

“We discovered that lung cancer leads to a progressive global loss of 5hmC in cfDNA, whereas hepatocellular carcinoma and pancreatic cancer lead to disease-specific changes in the cell-free hydroxymethylome,” the team found. “Our proof-of-principle results suggest that cell-free 5hmC signatures may potentially be used not only to identify cancer types but also to track tumor stage in some cancers.”

Cambridge Epigenetix said it has been granted broad and exclusive rights to U.S. Patent No. 10,041,938 for use of 5hmC as a diagnostic biomarker for cancer. That patent was granted in August 2018 and assigned to Children’s Medical Center Corp., the parent of Boston Children’s Hospital, and the U.S. Department of Health and Human Services.

“Detection of CRC remains a challenge, and the availability of a non-invasive, easy-to-administer and affordable screening test as our first initiative could transform the diagnosis, detection and treatment of pre-cancerous lesions and CRC,” stated David Johnson MD, MACG, FASGE, MACP, professor of medicine and Chief of Gastroenterology at Eastern Virginia Medical School in Norfolk, VA, a member of Cambridge Epigenetix’ clinical advisory board.

Dr. Johnson is a previous president of the American College of Gastroenterology whose work led to Virginia becoming the first U.S. state to mandate colon cancer screening via colonoscopy as the preferred standard.