New Data Show ClearNote Health's Epigenomic Platform Provides a Novel Tissue-Free, Liquid Biopsy-Based Approach to Identify Potential Predictive Biomarker Candidates to Radioligand Therapy Response in Patients With Pancreatic Neuroendocrine Tumors

ClearNote® Health, a company on a mission to enable longer lives for people with cancer through earlier detection, today announced results from a collaboration study with Novartis and the Norwegian Biobank assessing plasma-based epigenetic biomarkers associated with response to treatment with Lutathera® ([¹⁷⁷Lu]Lu-DOTA-TATE) in patients with pancreatic neuroendocrine tumors.

Presenting at the European Neuroendocrine Tumor Society (ENETS) 2024 conference, Dr. Jon Sponheim (Rikshospitalet, Oslo University Hospital) unveiled new data demonstrating the application of ClearNote Health's epigenomic technology platform (Virtuoso) in evaluating differences in 5hmC profiles of responders relative to short-responders prior to and during therapy with Lutathera. Differences in plasma-derived cell free DNA (cfDNA) 5hmC profiles after administration of Lutathera revealed biological responses consistent with radioligand therapy mechanism of action hypothesis. Results from the study, Abstract #F23, "5-Hydroxymethylcytosine profiling of plasma-derived circulating free DNA in patients with pancreatic neuroendocrine tumors treated with [177Lu]Lu-DOTA-TATE," demonstrates Virtuoso's ability to provide biological insights and biomarkers of response using only plasma.

"Our research collaboration with Novartis has demonstrated the power of ClearNote Health's cutting-edge epigenomic technology in the interrogation of predictive biomarkers of radioligand therapy response from a single blood draw," said Dave Mullarkey, CEO of ClearNote Health. "We are committed to partnering with pharma and research leaders in the industry to advance their precision medicine programs and help improve patient outcomes."

The study used Virtuoso to generate cfDNA 5hmC profiles from plasma samples obtained from patients with pancreatic neuroendocrine tumors who received Lutathera, an FDA-approved radiolabeled somatostatin analog for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The comparison of plasma-derived cfDNA 5hmC profiles revealed differences that distinguish patients responding to therapy from those not responding before and on treatment.

This collaboration underscores ClearNote Health's commitment to empowering biopharmaceutical innovation in developing better drugs through cutting-edge molecular diagnostic technologies. For more information about ClearNote Health and its innovative solutions, visit www.clearnotehealth.com.

About ClearNote Health

ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company's CLIA- and CAP-accredited laboratory is located in San Diego, Calif. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn. To learn more about the Avantect Pancreatic Cancer Test, visit www.avantect.com.