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. "While AMPLIFY-7P did not meet its primary endpoint in the intent-to-treat study population, promising efficacy signals in patients with lower residual disease burden sharpen our path forward," said Robert Connelly, President and Chief Executive Officer of Elicio. "We identified the patients who benefit most, validated the biology, and demonstrated a favorable safety profile that supports extended dosing in Phase 3. In a disease where no approved options exist after surgery, we believe AMPLIFY-7P demonstrates that ELI-002 7P, an mKRAS-targeted immunotherapy, can generate robust immune responses associated with improved clinical outcomes." Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio, added, "The AMPLIFY-7P trial generated important clinical and biological insights that have sharpened our development strategy and strengthened our conviction in ELI-002 7P. The stronger treatment effect observed in completely resected R0 patients, combined with the robust relationship between KRAS-specific T-cell responses and clinical outcomes, supports a clear Phase 3 path focused on patients most likely to benefit from treatment. We look forward to discussing these findings with regulators and believe the results provide important support for the broader application of AMP-enabled immunotherapies across multiple oncogenic drivers." Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology