other material
confidence high
sentiment negative
materiality 0.75
Elicio Phase 2 AMPLIFY-7P misses primary DFS endpoint; positive R0 subgroup guides Phase 3
Elicio Therapeutics, Inc.
- AMPLIFY-7P did not meet primary endpoint of DFS in ITT; R1 resection imbalance (19% vs 10%) favored observation arm.
- Post-hoc analysis in R0 patients showed HR 0.65 (p=0.048); mDFS 23.8 mo vs 12.8 mo; 84% of study population.
- mKRAS-specific T cell responses strongly correlated with DFS (HR 0.22, p<0.0001, n=90).
- Refined Phase 3 plan targets R0 resected patients with additional dosing; cash runway into Q4 2026; exploring financing.
- Favorable safety: no treatment-related discontinuations or deaths.