NEW YORK – Natera and Elicio Therapeutics said on Tuesday that they are collaborating on a prospective, multicenter Phase I/II clinical trial of Elicio's immuno-oncology drug ELI-002 in pancreatic cancer patients.
The 108-patient trial will test ELI-002, which targets KRAS mutations, in patients with pancreatic ductal adenocarcinoma (PDAC) who have undergone neoadjuvant chemotherapy followed by pancreatectomy. It will open at 10 to 12 US sites in the first half of this year.
Natera's Signatera personalized circulating tumor test will be used to select eligible patients with KRAS-mutant tumors who have detectable molecular residual disease (MRD) after surgery and are therefore at high risk of relapse. In addition, these patients will be monitored serially with Signatera to assess MRD clearance throughout the study.
"We are excited to partner with Natera to select and monitor patients using breakthrough Signatera technology," said Christopher Haqq, executive VP, head of R&D, and chief medical officer at Elicio, in a statement.
Elicio said that ELI-002, which targets all seven position 12 and 13 KRAS mutations, representing approximately a quarter of all human solid tumors, could be used to treat several types of cancer that are driven by KRAS mutations, including pancreatic, colorectal, and lung cancer.
"We're confident that this study will further demonstrate Signatera's ability to enrich clinical trials and accelerate the development of much-needed therapies" such as ELI-002, said Alexey Aleshin, senior medical director at Natera, in a statement.
The new trial joins several others that involve the Signatera test, such as the COLUMBIA-2 trial, sponsored by AstraZeneca, that studies stage II or III microsatellite-stable CRC patients; the 1,500-patient CIRCULATE-IDEA trial, a collaboration with the National Cancer Center Japan, in patients with stage II or III colon cancer; and the BESPOKE CRC trial, in patients with stage II or III colorectal cancer. Â
The test gained breakthrough device designation from the US Food and Drug Administration for certain cancer types last spring and received a draft local coverage determination from Medicare contractor Palmetto for certain stage II or stage III colorectal cancer patients last summer.