Elicio Therapeutics reports Phase 2 AMPLIFY-7P data at ESMO 2026
Elicio Therapeutics has presented late-breaking Phase 2 data on camupepimut (ELI-002 7P), its mutant KRAS-targeting amphiphile vaccine, at the ESMO Congress 2026 in Madrid, with simultaneous publication in Nature Medicine. The randomised AMPLIFY-7P study enrolled 144 patients with mutant KRAS-driven pancreatic ductal adenocarcinoma following standard locoregional therapy across 24 US clinical sites.
The study did not meet its pre-specified primary endpoint of disease-free survival in the intent-to-treat population, with a hazard ratio of 0.85. However, Elicio was quick to contextualise that result. A notable baseline imbalance in ctDNA positivity, a strong predictor of recurrence, was more prevalent in the camupepimut arm (20.8%) than in the observation arm (12.5%). After multivariable adjustment for baseline prognostic factors, the association between camupepimut treatment and lower recurrence or death risk strengthened considerably, yielding an adjusted HR of 0.47 (p=0.0086).
Subgroup findings and immune data
Across multiple pre-specified subgroup analyses, camupepimut showed consistent and favourable treatment-effect trends. In the 93 ctDNA-negative patients at baseline, recurrence or death occurred in 27.4% of camupepimut-treated patients versus 48.4% under observation (HR 0.51; p=0.0280), with median DFS not reached in the treatment arm versus 21.2 months in the observation arm. In the smaller, higher-risk ctDNA-positive subgroup of 26 patients, median DFS was 4.3 months versus 1.9 months (HR 0.57; p=0.0489). Patients who had not received prior radiation, a group of 106, had median DFS of 23.8 months with camupepimut versus 10.4 months under observation (HR 0.59; p=0.0221); prior radiation was associated with lower baseline lymphocyte counts and attenuated mutant KRAS T-cell responses.
Translational findings were among the most striking data points. Camupepimut induced mutant KRAS-specific T-cell responses in 99% of evaluable treated patients, with a median 44.3-fold increase from baseline. Responses persisted for at least 46 weeks in 95.5% of evaluable patients, and 85% generated both CD4 and CD8 responses. In an exploratory analysis, patients with immune responses above a pre-identified threshold had a median DFS that was not reached, versus 6.08 months in those below the threshold (HR 0.22; p less than 0.0001). The safety profile was favourable, with grade 3 or higher adverse events in 10.4% of camupepimut patients versus 14.6% under observation.
Regulatory path and competitive context
Elicio plans to discuss the full AMPLIFY-7P dataset with the FDA to inform a potential Phase 3 study in adjuvant pancreatic cancer. Chief medical officer Christopher Haqq said the translational findings "provide a strong scientific and clinical rationale for a refined Phase 3 design incorporating optimised patient stratification, extended treatment duration and potential combination approaches."
Pancreatic cancer remains one of oncology's most intractable settings, with five-year survival rates below 15% and few approved agents demonstrating meaningful benefit in the adjuvant context. The KRAS-targeting immunotherapy space is increasingly crowded, with mRNA vaccine approaches from Moderna and BioNTech under evaluation, as well as small-molecule KRAS inhibitors such as sotorasib and adagrasib that target specific mutations. Elicio's off-the-shelf amphiphile platform differentiates on breadth, covering seven of the most common KRAS mutations, and on immune durability, though the Phase 3 design will need to resolve the patient-selection question that the AMPLIFY-7P ITT result leaves open. Robust ctDNA-based stratification at enrolment will likely be a central feature of any registrational trial, and regulators may scrutinise the reliance on subgroup and adjusted analyses to support Phase 3 progression.