On June 29, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported the initiation of AMPLIFY-201, a Phase 1/2 dose-escalation study evaluating the safety and preliminary efficacy of ELI-002, the Company’s therapeutic vaccine that is being investigated as a potential treatment for patients with KRAS-driven tumors who have minimal residual disease following surgical tumor resection (Press release, Elicio Therapeutics, JUN 29, 2021, View Source [SID1234584468]). The trial will enroll patients with RAS-mutated pancreatic ductal adenocarcinoma (PDAC), colorectal cancer and other solid tumors with KRAS and NRAS mutations. ELI-002 is an investigational, subcutaneous, Amphiphile (AMP) KRAS therapeutic vaccine that targets the lymph node by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. It contains AMP mKRAS peptides and a proprietary AMP CpG adjuvant.
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"RAS mutations, particularly KRAS mutations, are found in approximately 25% of tumors and have been considered difficult to target due to the number of mutations that can cause disease. In this study, our lymph node-targeted therapeutic vaccine ELI-002 is designed to target all seven common KRAS mutations, including G12C," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "We believe that the ability of our proprietary AMP platform to deliver ELI-002 directly to the lymph nodes, the control center of the immune system, may stimulate an enhanced immune response."
About AMPLIFY-201
AMPLIFY-201 is a Phase 1/2 clinical trial of ELI-002 in patients with solid tumors, including colorectal cancer, or CRC, or pancreatic ductal adenocarcinoma, or PDAC. The AMPLIFY-201 trial is being conducted at multiple sites, including U.S. cancer treatment institutions such as MD Anderson, Memorial Sloan Kettering, Sarah Cannon Research Institute, Massachusetts General Hospital, City of Hope, Washington University St. Louis, and Henry Ford Health System. Following an initial dose escalation phase, we intend to evaluate the potential of ELI-002 as a treatment for a number of KRAS-mutated cancers. AMPLIFY-201 is strategically constructed to target patients with minimal residual disease, or MRD, a stage where tumor burden and immunosuppressive effects within the tumor are lower. The Phase 1/2 trial employs an investigational in vitro diagnostic device, or IVD, that is intended to detect circulating tumor DNA, or ctDNA, and identify patients who show signs of minimal residual disease in their blood before relapse is detected in traditional radiographic scans.
Endpoints including safety, determination of maximum tolerated dose, ctDNA change from baseline, relapse free survival and immunological responses including lymph node enlargement, cytokine activity and immune response will be assessed. We anticipate initial safety, dose escalation, and correlative biomarker data from the Phase 1 portion of the trial to be available by the first half of 2022. Please refer to clinicaltrials.gov [NCT04853017] for additional clinical trial information.
The purpose of the Phase 1/2 multi-center, dose-escalation study is to evaluate the safety and preliminary efficacy of ELI-002 in patients with KRAS-driven cancers with minimal residual disease following surgery to remove the tumor. Patients will receive escalating doses of ELI-002 to determine safety and tolerability and to assess preliminary antitumor activity. The primary endpoints are, to define the maximum tolerable dose (MTD), recommended Phase 2 dose (RP2D), and incidence of adverse events (AE) for Phase 1 and relapse-free survival (RFS) for Phase 2. The secondary endpoints are, ctDNA clearance rate for Phase 1, and incidence of AEs, 1-year RFS, overall survival (OS) and the objective response rate (ORR) for Phase 2, among other endpoints. The trial is expected to enroll approsimately 150 patients. Please refer to clinicaltrials.gov [NCT04853017] for additional clinical trial information.
About ELI-002
ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they potentially enhance action on key immune cells.
About the Amphiphile Platform
Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.
Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.
Amphiphile platform is thought to deliver immunotherapeutics to target the lymph node directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.