Elicio Therapeutics Inc. (NASDAQ:ELTX) stock is trading lower on Monday after disappointing results from its Phase 2 AMPLIFY-7P study of ELI-002 7P in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma (PDAC) following standard locoregional treatment.
Elicio Therapeutics Misses Primary Endpoint But Highlights Early Benefit Signals
While the trial did not achieve its pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population, the company pointed to early treatment benefits and subgroup findings that are shaping its planned Phase 3 program.
The randomized study evaluated ELI-002 7P as an adjuvant treatment in patients with mKRAS-driven PDAC.
According to the company, landmark analyses conducted during active treatment showed an approximately 14% absolute improvement in DFS at both three and six months compared with observation.
Subgroup Analyses Show Stronger Outcomes In R0-Resected Patients
Elicio said treatment-arm separation emerged during active therapy and continued through nine months.
Post-hoc analyses identified R1 resection as a negative prognostic indicator and suggested stronger treatment effects among patients who underwent R0 resections.
In that subgroup, which represented roughly 84% of enrolled patients, ELI-002 7P was associated with improved disease-free survival, with a hazard ratio of 0.65.
The company also reported a strong correlation between mKRAS-specific T-cell responses and clinical outcomes.
Patients generating the strongest immune responses experienced the most favorable disease-free survival outcomes, supporting the biological activity of the investigational therapy.
Company Refines Phase 3 Development Plans
Based on insights from AMPLIFY-7P, Elicio said it plans to focus its Phase 3 development strategy on patients with R0 resections who have completed standard locoregional therapy.
The proposed registrational study is expected to use disease-free survival as its primary endpoint and include additional dosing beyond the current immunization and booster regimen.
ELI-002 7P demonstrated a favorable safety profile in the Phase 2 study, with no treatment-related discontinuations or deaths reported. The company also stated that treatment was associated with proportionally fewer adverse events than standard-of-care observation.
Elicio expects its existing cash and cash equivalents to fund planned operations into the fourth quarter of 2026.
ELTX Stock Price Activity: Elicio Therapeutics shares were down 72.32% at $4.11 at the time of publication on Monday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
Photo Courtesy: mi_viri on Shutterstock.com
