Elicio’s Phase 2 AMPLIFY-7P trial missed its primary endpoint in pancreatic cancer, but ELI-002 7P improved disease-free survival in R0-resected patients and advanced toward Phase 3.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Elicio Therapeutics reported topline results from the Phase 2 AMPLIFY-7P trial (NCT05726864) evaluating ELI-002 7P in patients with mutant KRAS (mKRAS)-driven pancreatic ductal adenocarcinoma (PDAC) following surgery and standard locoregional therapy. The study did not meet its primary endpoint of disease-free survival (DFS) in the intent-to-treat population. However, subgroup and immune-response analyses identified signals that could support a registrational development path.
KRAS-Targeted Immunotherapy in a High-Risk Setting
Patients with resected pancreatic cancer remain at substantial risk of relapse despite surgery and chemotherapy, and no approved therapies are available after completion of standard treatment.
ELI-002 7P is an investigational AMP-based immunotherapy targeting seven common KRAS mutations. The therapy combines AMP-modified KRAS peptide antigens with an AMP-modified CpG adjuvant to stimulate tumor-specific immune responses through lymph node delivery.
Clinical Activity Emerges in R0-Resected Patients
The study enrolled 144 patients with Stage I-III mKRAS-positive PDAC across 24 U.S. centers and compared ELI-002 7P with observation following completion of standard therapy.
Investigators identified an imbalance in surgical margin status between treatment groups, with a higher proportion of R1 resections in the ELI-002 arm (19% versus 10%). R1 resection is a recognized risk factor for disease recurrence.
Post-hoc analyses showed a stronger treatment effect among patients with complete R0 resections. In this subgroup, ELI-002 7P reduced the risk of recurrence or death by 35% compared with observation (HR 0.65; p=0.048). Median DFS reached 23.8 months versus 12.8 months in the control arm, while 18-month recurrence rates were 9.5% lower with treatment. R0 patients represented approximately 84% of the study population.
Landmark analyses also showed an approximately 14% absolute improvement in DFS during active treatment at both three and six months, suggesting early clinical activity.
Immune Responses Correlate with Outcomes
The trial provided biological evidence supporting the mechanism of action. Patients who generated strong mKRAS-specific T-cell responses experienced substantially better outcomes than those with weaker responses, with a hazard ratio of 0.22 for DFS (p<0.0001). The findings reinforce the link between KRAS-directed immune activation and clinical benefit.
ELI-002 7P was generally well tolerated, with no treatment-related discontinuations or deaths reported during the study.
Phase 3 Strategy Takes Shape
Based on the findings, Elicio plans to advance ELI-002 7P into a Phase 3 study focused on R0-resected patients following standard locoregional therapy. The trial is expected to evaluate extended dosing beyond the current immunization and booster regimen, with DFS serving as the primary endpoint.
The company is evaluating financing and partnership opportunities to support late-stage development and expects its current cash runway to extend into the fourth quarter of 2026.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.