Elicio says Phase 2 AMPLIFY7P misses DFS endpoint, pivots Phase 3 plan for ELI002 7P to R0 patients

Elicio Therapeutics said its Phase 2 AMPLIFY-7P study of ELI002 7P in adjuvant pancreatic cancer missed the prespecified primary endpoint of disease-free survival in the intent-to-treat population, citing an imbalance in R1 resection patients (19% vs 10%). In a post-hoc analysis, the R0 completely resected subgroup, which made up about 84% of the study, showed a disease-free survival benefit (HR 0.65, p=0.048) and mKRAS-specific T-cell responses were strongly associated with clinical outcomes. The company said it has refined its Phase 3 strategy to focus on R0 patients and extend dosing, without disclosing new financing or regulatory milestones.