Elicio Therapeutics presents updated preliminary results from AMPLIFY-7P

Elicio Therapeutics (ELTX) presented updated preliminary results from the ongoing AMPLIFY-7P Phase 1 clinical trial of ELI-002, an Amphiphile cancer vaccine that targets KRAS-mutant tumors at the Society for Immunotherapy of Cancer 2024 Annual Meeting. The poster presentation includes updated translational data highlighting the relationship between vaccine immunogenicity and DFS. The AMPLIFY-7P study is evaluating ELI-002 in patients with mKRAS-driven solid tumors following standard locoregional treatment and who remain at risk of disease recurrence. The randomized Phase 2 portion of AMPLIFY-7P in patients with pancreatic cancer is ongoing, with enrollment expected to be completed in Q4 2024. ELI-002 immunogenicity was based on a longitudinal ex vivo analysis of peripheral T cells collected from a total of 12 evaluable patients who received either a 1.4 mg dose or the recommended Phase 2 dose of 4.9 mg, with a September 11, 2024 cutoff date. Key observations include: mKRAS-specific T cell responses versus baseline were observed in all evaluable patients; median response in 4.9 mg group was 12-fold higher than the 1.4 mg dose group T cell specificities covered all seven KRAS mutants targeted by ELI-002; strongest responses observed were against the most common variants, including KRAS G12R, G12D, and G12V. Induced mKRAS-specific T cells were fully functional and capable of secreting both granzyme B and perforin Magnitude of T cell response correlated with duration of DFS, based on a May 23, 2024 cutoff date; highest three quartiles of T cell responders have not yet reached mDFS, whereas the lowest quartile achieved a mDFS of 3.1 months (p=0.0027) T cell responses against mKRAS antigens were shown to be durable, extending up to 1.5 years Antigen spreading detected in 100% of RP2D-treated patients (n=6), with T cell responses observed against 67.5% of tested neoantigens identified from patient-specific mutanomes-suggesting ELI-002-induced tumor immunosurveillance to personalized tumor neoantigens beyond mKRAS As of a May 23, 2024 safety data cutoff, ELI-002 remains safe and well-tolerated, with no dose-limiting toxicities or cytokine release syndrome observed