Elicio Therapeutics' ELI-002 7P failed to meet its primary endpoint in a Phase II randomized trial in adjuvant pancreatic cancer, sending shares tumbling 47%.²

Despite the fallout of the results, the company says post-hoc analyses have sharpened its path to a Phase III program focused on a more precisely defined patient population.

What did the trial show?

The Amplify-7P study, which enrolled 144 patients across 24 U.S. sites, evaluated ELI-002 7P versus observation in patients with resected Stage I–III mutant Kras-driven pancreatic ductal adenocarcinoma who had completed surgery and standard locoregional therapy and were radiographically free of disease at enrollment.¹ The study did not meet it’s prespecified primary endpoint of disease-free survival in the intent-to-treat population.

Post-hoc landmark analyses suggested early clinical activity during the active treatment period. At both three and six months, ELI-002 7P was associated with approximately a 14% absolute improvement in DFS rates compared with observation, 90.3% versus 76.6% at three months (p=0.022) and 75.7% versus 61.7% at six months (p=0.056), with treatment-arm separation persisting through nine months.¹

A key confound in the overall analysis was an imbalance in baseline resection status between arms. R1 resection, in which microscopic residual disease remains following surgery and is a known adverse prognostic factor, was present in 19% of patients in the ELI-002 7P arm compared with 10% in the observation arm. Post-hoc multivariable analyses identified R1 status as a negative predictor of recurrence. When the analysis was restricted to R0 resected patients, who had no residual disease following surgery and represented approximately 84% of the enrolled population, the treatment effect was more pronounced, with a hazard ratio of 0.65.¹

The trial also demonstrated a strong biological signal linking immune response to clinical outcome, as patients with the strongest mKRAS-specific T-cell responses, defined as greater than 9.17-fold change from baseline, experienced significantly improved DFS compared with lower responders (HR 0.22, p<0.0001, n=90 evaluable).¹

"While Amplify-7P did not meet its primary endpoint in the intent-to-treat study population, promising efficacy signals in patients with lower residual disease burden sharpen our path forward," said Robert Connelly, president and CEO of Elicio. "We identified the patients who benefit most, validated the biology, and demonstrated a favorable safety profile that supports extended dosing in Phase 3."

What is ELI-002 7P?

ELI-002 7P is a cancer immunotherapy built on Elicio's proprietary AMP platform, which is designed to deliver immunotherapy directly to the lymph nodes by latching onto albumin as it travels to lymphatic tissue and was originally developed at the Massachusetts Institute of Technology.¹

ELI-002 7P is a seven-peptide formulation targeting seven of the most common KRAS mutations, which are present across approximately 25% of all solid tumors. The drug is administered subcutaneously and consists of AMP-modified mutant KRAS peptide antigens combined with an AMP-modified CpG oligodeoxynucleotide adjuvant.¹

"Future progress in pancreatic cancer will increasingly depend on precision medicine approaches that identify patients most likely to benefit from targeted and immune-based therapies," said Eileen M. O'Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center. "These findings show the promise of immunological targeting of mKRAS in patients previously considered to be refractory to immunotherapy."

What is Elicio's Phase III strategy?

Elicio says the Amplify-7P data has informed a refined Phase III development strategy centered on R0 resected patients, who demonstrated the clearest treatment benefit in post-hoc analyses.¹ The planned registrational study is expected to extend the treatment duration beyond the initial immunization and booster regimen used in Phase II, with the goal of enhancing the durability of anti-tumor immune responses and a primary endpoint of DFS.¹

The company cautioned that initiating the Phase III study is subject to financing, and as of the announcement, Elicio's cash is expected to support operations only into the fourth quarter of 2026, and the company said it is evaluating multiple strategic financing and partnership opportunities to fund the Phase III adjuvant PDAC program.¹

The financial runway and the absence of a statistically significant result in the primary endpoint analysis are likely to complicate those efforts, even as the company argues the biology underlying ELI-002 7P remains intact.

Sources

1. Elicio Therapeutics Reports Results from Phase 2 AMPLIFY-7P Study and Outlines Refined Phase 3 Development Strategy for ELI-002 7P in Adjuvant Pancreatic Cancer Elicio Therapeutics June 15, 2026 https://www.globenewswire.com/news-release/2026/06/15/3311657/0/en/elicio-therapeutics-reports-results-from-phase-2-amplify-7p-study-and-outlines-refined-phase-3-development-strategy-for-eli-002-7p-in-adjuvant-pancreatic-cancer.html
2. Elicio Therapeutics Shares Plunge After Pancreatic Cancer Study Misses Main Goal (ELTX) Yahoo Finance June 15, 2026 https://finance.yahoo.com/sectors/healthcare/articles/elicio-therapeutics-shares-plunge-pancreatic-134532473.html