14 February 2020 - - US-based immuno-oncology company Elicio Therapeutics and DNA testing specialist Natera, Inc. (NASDAQ: NTRA) are collaborating in a prospective, multicenter Phase 1/2 study of ELI-002, an Amphiphile immuno-oncology therapeutic targeting KRAS mutations in the adjuvant setting for patients with pancreatic ductal adenocarcinoma who have undergone neoadjuvant chemotherapy followed by pancreatectomy, the companies said.

IND submission for the 108-patient trial which will open at 10-12 US sites will be in the first half of 2020.

Natera's tumor-informed and personalized ctDNA platform, Signatera, will be used to select eligible patients whose tumors harbor a mutant KRAS allele and are at high risk for relapse because they have detectable molecular residual disease post-surgery.

Signatera will also be used to perform serial monitoring to assess the %age of patients achieving MRD clearance throughout the study.

ELI-002 targets all seven position 12 and 13 KRAS mutations, representing approximately 25% of all human solid tumors.

Elicio believes that ELI-002 has the potential to become a universal mKRAS therapy with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer.

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body's own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence.

Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC's) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease.

This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms.

By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses.

This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

Elicio Therapeutics, based in Cambridge, MA, is committed to transforming the lives of patients and their families by re-engineering the body's immune response to defeat cancer.

By combining expertise in materials science and immunology, Elicio is engineering potent Amphiphile immunotherapies, including lymph node targeted cell therapy activators, immunomodulators, adjuvants and vaccines for an array of aggressive cancers.

Elicio's lead Amphiphile vaccine targeting KRAS-driven cancers will begin initial patient studies in pancreatic cancer patients in the first half of 2020. These programmes are followed by a broad preclinical pipeline of lymph node targeted immunotherapies.

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease assessment in patients previously diagnosed with cancer.

The test is available for clinical and research use, and in 2019 it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalised and tumor-informed, providing each individual with a customised blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor.

This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood.

Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.

Signatera was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments. This test has not been cleared or approved by the US Food and Drug Administration.

Although FDA does not currently clear or approve laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.