Wednesday, February 12, 2020
Elicio Therapeutics, a next generation immuno-oncology company, and Natera, Inc., a global leader in cell-free DNA testing, today announced 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. 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 (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.
About Elicio Therapeutics
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 programs are followed by a broad preclinical pipeline of lymph node targeted immunotherapies. For more information, please visit https://elicio.com.
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) 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 personalized and tumor-informed, providing each individual with a customized 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 (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to obstetricians, oncologists, transplant nephrologists, academic researchers, drug developers, and genetic laboratories through its cloud-based software platform. Natera's flagship cancer assay, Signatera, was designated by the FDA as a Breakthrough Device, and it received a draft coverage determination from Medicare for use in Stage II and III Colorectal cancer. For more information, visit www.natera.com, or follow Natera on LinkedIn or Twitter.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
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