Elicio Therapeutics, Inc. (Nasdaq: ELTX) has announced the completion of enrollment in the Phase 2 AMPLIFY-7P study, a randomized trial evaluating ELI-002 7P in patients with mutant KRAS (mKRAS)-driven pancreatic ductal adenocarcinoma (PDAC) who are at high risk of relapse following surgery. The study, identified by NCT05726864, enrolled 135 patients.
The Phase 2 AMPLIFY-7P study is a multicenter, open-label trial assessing the safety, tolerability, and efficacy of ELI-002 7P. Patients were randomized in a 2:1 ratio to receive subcutaneous injections of ELI-002 7P versus standard of care observation. Those in the observation arm have the option to cross over to ELI-002 7P treatment upon confirmed disease progression. All participants had undergone successful resection of locoregional PDAC (Stages I, II, or III) harboring KRAS mutations, including G12D, G12R, G12V, G12C, G12A, G12S, or G13D, with enrollment irrespective of minimal residual disease (MRD) status.
Study Design and Endpoints
The primary endpoint of the Phase 2 trial is disease-free survival (DFS). Secondary endpoints include serum tumor biomarker responses, overall survival, and vaccine immunogenicity. The first patient was dosed in January 2024. A formal interim Phase 2 analysis, including DFS, reviewed by the study’s Independent Data Monitoring Committee, is expected in the first half of 2025. Possible outcomes include achieving pre-specified criteria for reporting primary endpoint analysis, continuing to final DFS analysis (expected in the second half of 2025), or meeting pre-specified criteria for futility.
ELI-002: An Amphiphile Immunotherapy
ELI-002 is an investigational Amphiphile (AMP) cancer vaccine designed to target cancers driven by mutations in the KRAS gene. It comprises AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant, administered via subcutaneous injection. The ELI-002 7P formulation aims to provide immune response coverage against seven of the most common KRAS mutations present in approximately 25% of all solid tumors.
Prior Clinical Data
Elicio previously reported Phase 1a study results from AMPLIFY-7P, demonstrating a favorable safety profile, robust T-cell responses, antigen spreading, and encouraging preliminary DFS data in PDAC patients. Data from the single-arm Phase 1a portion of AMPLIFY-7P, highlighting the relationship between vaccine immunogenicity and DFS, were presented at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting.
Management Commentary
"We are pleased to announce the completion of enrollment in our lead ELI-002 Phase 2 AMPLIFY-7P study. The speed of study enrollment exceeded our expectations, reflecting high levels of investigator and patient interest in an off-the-shelf monotherapy treatment option for patients who completed neoadjuvant, perioperative, or adjuvant chemotherapy," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development and Chief Medical Officer. "We are now eagerly looking forward to the pre-planned interim data analysis as we continue working to bring this potentially transformative vaccine to cancer patients."
