Elicio Therapeutics Inc. (NASDAQ:ELTX) shares tumbled 47% on Monday after the company announced that its Phase 2 AMPLIFY-7P trial of ELI-002 7P in pancreatic cancer failed to achieve its primary endpoint of disease-free survival in the intent-to-treat population.
The study assessed ELI-002 7P against observation in patients with resected Stage I-III mutant KRAS-driven pancreatic ductal adenocarcinoma who had previously undergone surgery and standard locoregional treatment.
Baseline Imbalance Cited as Key Factor
Although the trial did not meet its main objective, Elicio said the results were affected by differences in baseline patient characteristics between the treatment and control groups.
According to the company, 19% of patients receiving ELI-002 7P had R1 resection status, compared with 10% in the observation arm. R1 resection status is recognised as a negative prognostic factor associated with a higher risk of disease recurrence.
Management believes this imbalance had a meaningful impact on the overall study outcome.
Post-Hoc Analysis Shows Benefit in Fully Resected Patients
A post-hoc review of patients who achieved complete tumour resection (R0), representing approximately 84% of trial participants, produced more encouraging findings.
Within this subgroup, ELI-002 7P generated a hazard ratio of 0.65 (p=0.048), with median disease-free survival reaching 23.8 months compared with 12.8 months for patients under observation.
Additional landmark analyses showed an absolute disease-free survival advantage of 14% at both the three-month and six-month marks during active treatment.
Immune Response Linked to Improved Outcomes
The trial also demonstrated a connection between mutant KRAS-specific T-cell responses and disease-free survival.
Patients who generated the strongest immune responses experienced a hazard ratio of 0.22, suggesting substantially improved outcomes compared with weaker responders.
Elicio noted that ELI-002 7P maintained a favourable safety profile throughout the study, with no treatment-related deaths or discontinuations reported.
Company Plans Refined Phase 3 Programme
Based on the findings, Elicio intends to pursue a revised Phase 3 development strategy focused on patients with R0 resections.
The proposed approach includes additional dosing beyond the initial vaccination and booster schedule used in the Phase 2 study, with the aim of improving long-term efficacy.
Cash Runway Extends Into Late 2026
The company said its current cash and cash equivalents are expected to fund operations into the fourth quarter of 2026.
Elicio is also exploring a range of strategic financing alternatives and potential partnership opportunities as it advances development plans for ELI-002 7P and its broader oncology pipeline.