On February 11, 2020 Elicio Therapeutics, a next generation immuno-oncology company, and Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported their collaboration 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 (PDAC) who have undergone neoadjuvant chemotherapy followed by pancreatectomy (Press release, Elicio Therapeutics, FEB 11, 2020, View Source [SID1234554178]). IND submission for the 108-patient trial which will open at 10-12 US sites will be in the first half of 2020.
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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 (MRD) post-surgery. Signatera will also be used to perform serial monitoring to assess the percentage of patients achieving MRD clearance throughout the study.
"This study addresses an unmet need in the adjuvant setting for PDAC patients," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "Pancreatic cancer remains one of the deadliest forms of cancer, with a high rate of relapse post-surgery and 90% of patients are affected by KRAS mutations. ELI-002 brings the common KRAS mutated peptides together with a powerful immune activating adjuvant and Elicio’s proprietary lymph node targeting technology. Potent immune responses from sending the T cells for education in the lymph node hold promise to stop recurrence. We are excited to partner with Natera to select and monitor patients using breakthrough Signatera technology."
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.
"I think this is a unique clinical trial implementing novel trial design and a novel therapeutic vaccine approach to address an unmet need in the treatment of pancreas cancer," said Colin Weekes, M.D., Ph.D., Director for Medical Oncology Research for Pancreatic Cancer at Massachusetts General Hospital and the principal investigator for the ELI-002 study.
"We are proud to partner with Elicio Therapeutics on this groundbreaking research," said Alexey Aleshin, M.D., MBA, Natera’s Senior Medical Director. "We’re confident that this study will further demonstrate Signatera’s ability to enrich clinical trials and accelerate the development of much needed therapies, like the ELI-002 KRAS-targeted Amphiphile."
About the Amphiphile Platform
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.