Elicio Therapeutics (ELTX) Study update summary

Study design and objectives

• The randomized Phase 2 AMPLIFY-7P trial enrolled 144 patients with resected Stage I-III mKRAS-driven PDAC across 24 U.S. sites, randomizing patients 2:1 to ELI-002 7P or observation.

• Both RO (complete) and R1 (microscopic residual) resected patients were included, with MRD-agnostic enrollment and stratification by nodal status.

• Patients had completed surgery and standard locoregional therapy and were radiographically disease-free at enrollment.

Key efficacy findings

• The primary endpoint of improved DFS was not met in the intent-to-treat population (HR 0.85, p=0.533), with median DFS of 23.8 months for ELI-002 7P vs. 21.2 months for observation.

• Early separation of DFS curves and landmark analyses at 3 and 6 months favored ELI-002 7P, suggesting antitumor activity in the adjuvant setting.

• Post hoc analyses showed a stronger DFS benefit in RO resected patients (HR 0.65, p=0.048), who represented 84% of the study population.

• Median DFS for RO patients was 23.8 months for ELI-002 7P vs. 12.8 months for observation.

Biological and safety insights

• Significant association found between mutant KRAS-specific T-cell responses and improved DFS; patients with >9.17x T cell fold-change had notably longer DFS (HR 0.22, p<0.0001).

• ELI-002 7P demonstrated a favorable safety profile, with no treatment-related discontinuations or deaths, fewer serious adverse events than observation, and only 5% experiencing dose delays.