Elicio Therapeutics, Inc. announced preliminary data from the ongoing AMPLIFY-7P Phase 1a study of its off-the-shelf investigational therapeutic cancer vaccine candidate, ELI-002 7P, in a poster presentation at the American Society of Clinical Oncology (?ASCO?) Annual Meeting, being held May 31-June 4, 2024, in Chicago, IL. The preliminary data showed ELI-002 7P was well tolerated with T cell responses correlating with a reduction in tumor biomarkers at the recommended Phase 2 dose (?RP2D?). The AMPLIFY-7P study is evaluating the 7-peptide formulation of Elicio?s cancer vaccine candidate, ELI-002 7P, in patients with mKRAS-driven solid tumors that are positive for minimal residual disease following standard locoregional treatment.

ELI-002 7P was developed with Elicio?s proprietary lymph node-targeting Amphiphile (?AMP?) technology designed to stimulate an immune response against the seven KRAS mutations (G12D, G12R, G12V, G12A, G12C, G12S and G13D) that drive 25% of all solid tumors. At data cutoff December 18, 2023, polyfunctional mKRAS-specific T cells were observed in 100% (n = 11/11) of evaluable patients. Both CD8+ and CD4+ responses were induced in 66.7% (4/6) of evaluable patients, at the RP2D 4.9 mg dose level, with higher median fold-change from baseline.

Biomarker reductions were observed in 2/5 (40%) at the 1.4 mg AMP-Peptides 7P dose level and in 5/7 (71%) at the RP2D 4.9 mg dose level in patients with reductions/clearance observed for all the common G12 (G12D, G12V, G12R) and G13 (D) KRAS mutations enrolled in the study to date. Minimum residual disease clearance was observed in one (1) G12V pancreatic (PDAC) patient at 4.9 mg. Antigen-spreading was observed with increased T cell responses targeting non-immunizing, personalised tumor neoantigens observed in 7/10 (70%) evaluable patients, 6/6 (100%) evaluable patients treated at the 4.9 mg RP2D dose level.

There were no dose-limiting toxicities, no treatment-related serious adverse events or cytokine release syndrome. The recommended Phase 2 dose (RP2D) is 10.0 mg AMP-CpG-7909 with 4.9 mg AMP-Peptides 7P. lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (?AMP?) cancer vaccine that targets cancers that are driven by mutations in the mKRAS-gene?a prevalent driver of many human cancers.

ELI-002 is comprised of two powerful components that are built with AMP technology consisting of AMP-modified mutant KRAS peptide antigens and an AMP-modified CpG adjuvant that is available as an off-the-shelf subcutaneous administration. ELI-002 2P (2 peptide formulation) is currently being studied in an ongoing Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy?(NCT04853017). ELI-002 7P (7 peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864).

The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.