Elicio Therapeutics Receives Positive IDMC Recommendation to Continue ELI-002 7P Study in Pancreatic Cancer.

Elicio Therapeutics has received a positive recommendation from the IDMC to continue its Phase 2 AMPLIFY-7P study for pancreatic cancer without modifications. The study targets seven KRAS mutations present in 88% of PDAC patients and has a final disease-free survival analysis expected by Q4 2025. The company's current financial resources are projected to support the study through Q1 2026.

Elicio Therapeutics, Inc. (Nasdaq: ELTX) has received a positive recommendation from the Independent Data Monitoring Committee (IDMC) to continue its Phase 2 AMPLIFY-7P study for pancreatic cancer without modifications. The study, which targets seven KRAS mutations present in 88% of pancreatic ductal adenocarcinoma (PDAC) patients, has shown preliminary signals of efficacy and safety.

The IDMC’s recommendation indicates that the trial can proceed as planned, with the final disease-free survival (DFS) analysis anticipated in the fourth quarter of 2025. The company's current financial resources are projected to support the study through the first quarter of 2026, extending beyond the anticipated final DFS analysis.

Elicio Therapeutics previously reached alignment with the U.S. Food and Drug Administration (FDA) on the key elements of the planned pivotal Phase 3 study design. Following the final DFS analysis, the company plans to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study.

The AMPLIFY-7P trial is a 2:1 randomized, open-label, multicenter clinical trial that enrolled 144 patients at 24 U.S. sites to evaluate the effectiveness and safety of ELI-002 7P monotherapy compared to standard of care (SOC) in improving DFS in patients with PDAC in the adjuvant setting post local therapy. ELI-002 7P treatment consists of six doses, followed by an observation period of eight weeks, and followed by four additional booster doses.

PDAC is an aggressive cancer with a five-year survival rate of 13% and is projected to become the second leading cause of cancer death in the U.S. by 2030. ELI-002 7P is an investigational, off-the-shelf, immunotherapy vaccine administered by subcutaneous injection.

Elicio Therapeutics is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. The company’s current cash runway extends into Q1 2026, past the anticipated final DFS analysis [1].

References:
[1] https://elicio.com/press_releases/elicio-therapeutics-announces-positive-recommendation-by-idmc-to-continue-eli-002-7p-randomized-phase-2-study-in-pancreatic-cancer-without-modifications-to-final-analysis/