Elicio Therapeutics, Inc. (ELTX) reported results from its Phase 2 AMPLIFY-7P study, noting that while the trial did not meet its primary endpoint in the overall population, post-hoc analyses showed encouraging signs of benefit for certain patients with resected mKRAS-driven pancreatic cancer.
Pancreatic ductal adenocarcinoma (PDAC) remains one of the most aggressive cancers, with high relapse rates even after surgery and standard therapy. Elicio's ELI-002 7P, is designed to stimulate mKRAS-specific T-cell responses—an approach aimed at reducing recurrence risk in the adjuvant setting.
Post-Hoc Signals Suggest Benefit in R0-Resected Patients
The AMPLIFY-7P study did not meet its pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population.
However, Elicio reported that an imbalance in surgical margin status may have negatively affected results: the ELI-002 arm included more R1 resected patients (19% vs. 10%), a group known to have higher relapse risk.
In a post-hoc analysis of R0-Resected Patients—those with no residual disease—ELI-002 7P demonstrated a hazard ratio of 0.65 (p=0.048), with median DFS of 23.8 months vs. 12.8 months for observation (n=121). Absolute recurrence rates at 18 months were 9.5% lower in the ELI-002 arm.
Approximately 84% of patients in the study were R0-resected, representing a substantial population with high unmet need.
Landmark analyses during active ELI-002 7P treatment showed an early absolute DFS benefit of about 14% at both three and six months, with separation between treatment and observation arms maintained through nine months.
Biological Activity Supported by Immune Response Data
The company reported that mKRAS-specific T-cell responses strongly correlated with improved DFS, with a hazard ratio of 0.22 (p<0.0001) in an exploratory analysis (n=90). This correlation supports the biological activity of ELI-002 7P and its potential role in preventing recurrence.
Refined Phase 3 Strategy Based on Findings
Based on the Phase 2 results, Elicio plans a refined Phase 3 development strategy focused on R0 resected patients and additional dosing of ELI-002 EP.
The company believes this approach could address a significant unmet need in the adjuvant PDAC setting.
ELI-002 7P continued to show a favorable safety and tolerability profile, supporting potential long-term use and combination strategies.
Company Outlook
Elicio is evaluating multiple strategic financing and partnering opportunities to support future clinical development.
The company expects its current cash and cash equivalents to support planned operations into the fourth quarter of 2026 and noted that additional financing will be required to advance its refined Phase 3 strategy, and is actively assessing funding options.
The company will host a conference call to discuss the results and next steps.
ELTX has traded between $3.75 and $16.00 over the past year. The stock is currently trading at $4.03, down 72.83%.
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