The investigational multi-peptide vaccine ELI-002 7P has demonstrated significant potential in generating strong T-cell responses specific to mutant KRAS (mKRAS) among patients with pancreatic ductal adenocarcinoma (PDAC). Preliminary results from the ongoing phase 1/2 AMPLIFY-7P trial (NCT05726864) revealed that 89 patients treated with ELI-002 7P exhibited robust mKRAS-specific T-cell activation across a diverse range of human leukocyte antigen (HLA) types.
Among the participants, researchers identified a total of 1,132 unique primary class I and II HLAs, highlighting the genetic diversity within the study population. Notably, data presented in September 2025 indicated that 99% of evaluable patients (n = 90) achieved measurable mKRAS-specific T-cell activation, with a remarkable mean increase of 145.3-fold and a median increase of 44.3-fold over baseline. These findings underscore the vaccine’s potential applicability across a wide spectrum of PDAC patients.
In a news release, Robert Connelly, chief executive officer of Elicio Therapeutics, expressed optimism regarding the results, stating, “We are extremely pleased to see that mKRAS-specific T-cell responses are induced among patients with a diverse HLA background, suggesting that ELI-002 7P may be applicable to a broad range of patients with PDAC.” Connelly emphasized that these encouraging findings could significantly enhance the reach of immunotherapy for this challenging cancer type.
Insights from the AMPLIFY-7P Trial
The AMPLIFY-7P trial is designed to evaluate ELI-002 as a cancer immunotherapy targeting tumors associated with KRAS mutations. The vaccine consists of AMP-modified mKRAS peptide antigens combined with an adjuvant, ELI-004, formulated for subcutaneous administration. The study involves two formulations of the vaccine, with the 7-peptide design aimed at enhancing immune recognition against seven prevalent KRAS mutations, which are found in approximately 25% of solid tumors.
In the phase 2 segment of the trial, 158 patients with resected KRAS-mutant PDAC were enrolled across 28 sites in the United States. Patients were randomly assigned to receive either adjuvant ELI-002 7P or standard-of-care observation following local therapy, surgery, and chemotherapy, with or without radiation. The primary endpoint of this portion of the trial is disease-free survival, while secondary endpoints include overall survival and safety measures.
The phase 1a segment of the trial involved patients receiving weekly doses of ELI-002, with the 4.9-mg formulation selected for further evaluation in subsequent phases. During this phase, approximately 80% of participants exceeded an activity-associated threshold of a 9.5-fold response increase in T-cell activation.
Next Steps and Future Implications
As the trial progresses, an independent data monitoring committee recommended continuing the AMPLIFY-7P study in August 2025 after a planned interim safety and efficacy review. Investigators remain blind to the full phase 2 clinical efficacy results, including the correlation between T-cell responses and antitumor outcomes.
The findings from ELI-002 7P not only reinforce the potential of immunotherapy in treating pancreatic cancer but also highlight a critical unmet need in the management of this aggressive disease. With ongoing research and development, Elicio Therapeutics aims to expand the therapeutic options available for patients suffering from PDAC, potentially transforming the landscape of treatment for this challenging condition.
