Core Insights - Elicio Therapeutics presented updated results from the Phase 1 AMPLIFY-201 clinical trial for ELI-002, showing a median recurrence-free survival (mRFS) of 16.3 months and median overall survival (mOS) of 28.9 months in patients with KRAS-mutant tumors [1][3] - A strong correlation was observed between T cell response and mRFS, with ongoing trials expected to provide further insights in H1 2025 [2][3] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies for high-prevalence cancers, particularly mKRAS-positive pancreatic and colorectal cancers [4][5] - The company's lead product candidate, ELI-002, is an off-the-shelf cancer vaccine targeting common KRAS mutations, which are implicated in approximately 25% of all solid tumors [5][6] Clinical Trial Details - The AMPLIFY-201 trial enrolled 25 patients, including 20 with pancreatic ductal adenocarcinoma (PDAC) and 5 with colorectal cancer (CRC), all at high risk of relapse after surgery [2][3] - ELI-002 demonstrated a favorable safety profile, with no severe treatment-emergent adverse events reported [3] Efficacy Data - The updated data showed that patients with above-median T cell responses had not yet reached mRFS, while those with below-median responses had a mRFS of 4.0 months [3] - The mOS for the full study cohort was 28.9 months, which is comparable to historical controls for PDAC [3] Future Developments - Elicio is advancing a seven-peptide formulation of ELI-002 (ELI-002 7P) in a randomized Phase 2 study, with interim analysis expected in H1 2025 [2][6] - The company aims to leverage its AMP technology to enhance immune responses and improve patient outcomes in cancer treatment [7][9]
Elicio Therapeutics Presents Updated Results from ELI-002 Phase 1 AMPLIFY-201 Study at ESMO Immuno-Oncology Congress 2024