Elicio Therapeutics, Inc. (NASDAQ:ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, today announced results from the randomized Phase 2 AMPLIFY-7P study of camupepimut (ELI-002 7P), presented in a late-breaking Proffered Paper oral session at the European Society for Medical Oncology ("ESMO") Congress 2026 in Madrid, Spain, and simultaneously published in Nature Medicine: "Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial".
Across multiple pre-specified analyses, camupepimut demonstrated consistent and favorable treatment-effect trends in patients with and without detectable baseline ctDNA and in patients without prior radiation. While the study did not meet its pre-specified primary disease-free survival ("DFS") endpoint in the intent-to-treat ("ITT") population (HR 0.85), the results should be considered in the context of a baseline imbalance in ctDNA positivity, a strong predictor of recurrence, which was more prevalent in the camupepimut arm (20.8% vs. 12.5%). Translational analyses also demonstrated broad, persistent mutant KRAS-specific T-cell responses associated with longer DFS. Together, these findings inform a refined Phase 3 development strategy.
"The AMPLIFY-7P results provide important new insights into camupepimut’s clinical activity and reinforce our confidence in its potential for patients with pancreatic cancer," said Robert Connelly, President and Chief Executive Officer of Elicio. "We are encouraged by the consistent treatment-effect trends across pre-specified patient groups, including patients with and without detectable baseline ctDNA, and by the strong mKRAS-specific immune responses associated with clinical outcomes. These insights give us clear direction for our potential Phase 3 strategy."
Pre-Specified Analyses Show Consistent Treatment-Effect Direction Across Baseline ctDNA Subgroups
In the 93 patients with baseline ctDNA-negative status, median DFS was not reached in the camupepimut arm vs. 21.2 months in the observation arm (HR 0.51; nominal p=0.0280). Recurrence or death was observed in 27.4% (17/62) of camupepimut-treated patients vs. 48.4% (15/31) of patients in observation.
A consistent treatment effect was also observed in the smaller, higher-risk baseline ctDNA-positive subgroup (n=26). Median DFS was 4.3 months with camupepimut vs. 1.9 months with observation (HR 0.57; nominal p=0.0489).
Prior radiation predicted lower baseline lymphocyte counts and reduced camupepimut-induced mKRAS T cell responses. In pre-specified analysis, patients who had not received prior radiation (n=106) had median DFS of 23.8 months with camupepimut vs. 10.4 months with observation (HR 0.59; nominal p=0.0221).
Pre-specified Subgroup Arm N Median DFS HR, p-value
ctDNA negative
Camupepimut 62 Not Reached HR 0.51
Observation 31 21.2 Months P=0.0280
ctDNA positive
Camupepimut 20 4.3 Months HR 0.57
Observation 6 1.9 Months P=0.0489
No Prior Radiation
Camupepimut 73 23.8 Months HR 0.59
Observation 33 10.4 Months P=0.0221
Baseline Prognostic Imbalance Provides Important Context for ITT Results
Baseline ctDNA status emerged as a particularly strong prognostic marker. In a pooled analysis across treatment groups, median DFS was 4.2 months for ctDNA-positive patients versus 24.0 months for ctDNA-negative patients (HR 6.56; nominal p<0.000001). Patients with baseline ctDNA positivity were more prevalent in the camupepimut arm (20.8%; 20/96) than in the observation arm (12.5%; 6/48).
A multivariable model adjusting for baseline factors estimated an association between camupepimut treatment and lower recurrence risk (adjusted HR 0.47; p=0.0086), while elevated CA19-9 (adjusted HR 3.16; p<0.0001) and positive baseline ctDNA (adjusted HR 5.99; p<0.0001) were associated with higher risk.
Early DFS Separation and Immune Findings Support Further Evaluation
Six-month DFS was 75.7% with camupepimut vs. 61.7% with observation, a 14.0 percentage-point difference immediately following the treatment period supports evaluating treatment duration in future studies.
Camupepimut induced mutant KRAS-specific T-cell responses in 99% of evaluable treated patients (median 44.3-fold increase from baseline. Among patients evaluated for T-cell subsets, 85% generated both CD4 and CD8 responses. Responses persisted at least 46 weeks from baseline in 95.5% of evaluable treated patients; 13 of 15 patients in a selected subset showed responses to additional tumor targets.
In an exploratory analysis, stronger camupepimut-induced mutant KRAS-specific T-cell responses were associated with significantly longer DFS. Median DFS was not reached among patients with immune responses above a previously identified threshold (82%, 74/90) vs. 6.08 months among those below the threshold (HR 0.22; nominal p<0.0001).
Generally Well-Tolerated Safety Profile
Camupepimut was generally well tolerated, with no new safety signals observed. Grade 3 or higher adverse events occurred in 10.4% of patients receiving camupepimut vs. 14.6% under observation; serious adverse events occurred in 6.3% and 8.3%, respectively. No adverse events led to withdrawal of study medication.
"The Phase 2 translational findings build on and reinforce our Phase 1 observations, demonstrating that camupepimut generates broad and persistent mutant KRAS-specific T-cell responses, with stronger immune responses associated with longer DFS," said Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio. "These observations across both baseline ctDNA subgroups and camupepimut’s favorable safety and tolerability profile provide a strong scientific and clinical rationale for a refined Phase 3 design incorporating optimized patient stratification, extended treatment duration and potential combination approaches."
Implications for Further Development
Elicio plans to discuss the totality of AMPLIFY-7P findings with the U.S. Food and Drug Administration to inform a potential Phase 3 study in adjuvant pancreatic cancer. Areas for consideration include baseline ctDNA and other prognostic factors in stratification and patient selection, treatment duration, and combination strategies intended to deepen or sustain mutant KRAS-specific immune activity. Any future study design remains subject to regulatory discussion and further development planning.