Company granted broad and exclusive patent rights for the use of an epigenetic biomarker as a diagnostic tool for cancer.

5-hydroxymethylcytosine (5hmC) epigenetic sequencing technology platform being used to develop a screening test for the detection of colorectal and other cancers using a standard blood draw.

Company announces the appointment of new Chief Executive, Dr Suman Shirodkar, to lead the advancement of its scientific programmes.

Cambridge Epigenetix Ltd, a pioneer in the development and application of epigenetic technologies, today announces its discovery and development programme for a test to detect colorectal and other cancers. This follows completion of a c. $30 million funding round, as well as the acquisition of exclusive patent rights for its epigenetic sequencing platform.

Epigenetic changes act as a control layer for the genome and can alter gene expression, but not the genetic code itself. These alterations may involve the presence of small chemical groups on the building blocks, or nucleotide bases, which make up DNA. DNA from cancer cells has a distinct epigenetic signature, and this is the basis for the use of epigenetic tests in cancer testing.

“The global burden of colorectal cancer (CRC) is expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030,”¹ stated Dr David Johnson MD, MACG, FASGE, MACP, Professor of Medicine and Chief of Gastroenterology at Eastern Virginia Medical School, Norfolk, VA, who serves as a member of the company’s clinical advisory board. “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.” Dr Johnson has previously been President of the American College of Gastroenterology and has played a pivotal role in shaping the dialogue around colon cancer screening and early detection. He was instrumental in putting through the historic first legislation to mandate colon cancer screening using colonoscopy as the preferred standard in the state of Virginia, USA.

In support of its mission, the company has been granted broad and exclusive patent rights (US Patent number 10,041,938) for the use of epigenetic modification 5-hydroxymethylcytosine (5hmC) as a diagnostic biomarker for cancer. Cambridge Epigenetix is using proprietary technology for analysing 5hmC in circulating free DNA (cfDNA) to develop a test for detection of CRC. The company is currently conducting a large discovery study with over 2,000 patient samples, including healthy volunteers, and individuals with adenomas and all stages of CRC. This study follows encouraging preliminary results from profiling 5hmC in over 200 CRC and healthy volunteer cfDNA samples.² Several independent studies have indicated that measuring 5hmC in plasma circulating cfDNA is effective for non-invasive cancer detection. ^3,4

Sir Shankar Balasubramanian, co-founder of Cambridge Epigenetix, FRS, FMedSci, Herchel Smith Professor of Medicinal Chemistry in the Department of Chemistry at the University of Cambridge, said: “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 latest round of secured funding will advance the company’s proprietary technology platform, which enables the sensitive and specific detection of epigenetic biomarkers for cancer in blood and other liquid biopsy samples. Ahren Innovation Capital (UK) led the funding round with current US-based supporters GV, New Sciences Ventures and Sequoia Capital. Additionally, new investors - including DNA Capital (Brazil) - also participated, bringing the total amount raised by the company since founding to $56.5 million.

Alice Newcombe-Ellis, Founder & Managing Partner, Ahren Innovation Capital, said: “Cancer detection through liquid biopsy has the possibility of transforming human health. Our investment will help Cambridge Epigenetix build on its strong intellectual property foundation, based on the research conducted by Sir Shankar Balasubramanian and Professor Anjana Rao.”

Cambridge Epigenetix also announces the appointment of Dr Suman Shirodkar, MBBS, PhD as the CEO of the company. Dr Shirodkar has extensive leadership experience in the industry and will lead the next phase of development of the diagnostic test. Prior to joining Cambridge Epigenetix, Dr Shirodkar led product teams in oncology, HIV, and cardiovascular medicine at Pfizer and Novartis.

“It is a very exciting time to be leading Cambridge Epigenetix” commented Dr Suman Shirodkar. “Our ability to detect 5hmC in circulating, cell-free DNA, and the discovery and development of a liquid biopsy signature for tumours, could revolutionise cancer care and decrease cancer mortality through widespread screening, early detection and timely intervention. 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”.

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