Elicio Therapeutics Reports Results From Randomized Phase 2 AMPLIFY-7P Study Evaluating ELI-002 7P In Patients With Adjuvant mKRAS-Driven Pancreatic Ductal Adenocarcinoma

• AMPLIFY-7P did not meet the pre-specified primary endpoint of disease-free survival ("DFS") in the intent-to-treat population.
• Randomization balanced most prognostic factors between arms. However, the ELI-002 7P arm had a higher proportion of R1 resected (higher residual disease, tumor present at or within 1 mm of surgical margin) patients compared with the observation arm (ELI-002 7P 19% vs. observation 10%), a known adverse prognostic factor for recurrence.  
• R1 patients have increased relapse-risk, implying that this imbalance meaningfully and negatively impacted the ELI-002 arm.
• Post-hoc analysis identified a stronger DFS hazard ratio in the R0, completely resected population (post-hoc HR 0.65, p=0.048, ELI-002 7P mDFS 23.8 mo vs observation 12.8 mo, n=121).   Absolute recurrence rates observed at 18 months were 9.5% lower for the ELI-002 7P arm.
• Lower residual disease (R0 completely resected) patients represented approximately 84% of the AMPLIFY-7P study, indicating potential for a significant population with high unmet need.
• Mutant KRAS ("mKRAS")-specific T cell responses strongly correlated with improved DFS, supporting biological activity of ELI-002 7P (HR 0.22, p<0.0001, n=90).
• Findings inform a refined Phase 3 development strategy focused on a defined R0 resected population and additional ELI-002 7P dosing, with the potential to address a significant unmet need and market opportunity in the adjuvant setting.
• The favorable safety and tolerability profile of ELI-002 7P supports the potential for longer-term administration and combination approaches.
• Elicio is evaluating multiple strategic financing and partnering opportunities to support future clinical development.
• Elicio will host a conference call today, Monday, June 15, 2026, at 8:30 AM ET.

BOSTON, June 15, 2026 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (NASDAQ:ELTX, "Elicio" or the "Company"))), a clinical-stage biotechnology company developing next-generation immunotherapies for mKRAS-driven cancers, today reported results from its randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma ("PDAC") following completion of standard locoregional therapy.

The AMPLIFY-7P study did not meet its pre-specified primary DFS endpoint in the intent-to-treat population. However, landmark analyses during active ELI-002 7P treatment indicated early treatment benefit. Post-hoc landmark analyses showed a consistent ~14% absolute DFS benefit during active treatment at both 3 and 6 months, suggesting early clinical activity, with treatment-arm separation persisting through 9 months.

While nodal status, the prespecified stratification factor, was balanced between treatment arms, a higher proportion of patients with the adverse prognostic factor, R1 resection status, were included in the ELI-002 7P arm (19% vs. 10%). Post-hoc analyses showed significant DFS improvement (R0: HR 0.65, p=0.048, n=121) in lower residual disease patients. Importantly, this subgroup represented approximately 84% of enrolled patients. Currently, there are no approved therapies following locoregional treatment.

The study informed a refined Phase 3 development strategy focused on a defined, lower residual disease, R0 resected population with additional dosing. The study also demonstrated a strong association between mKRAS-specific immune responses and clinical outcomes (HR 0.22, p<0.0001, n=90), supporting the biological activity of ELI-002 7P.