ELI-002 7P Elicits Robust T-Cell Responses in KRAS+ Pancreatic Cancer

An independent data monitoring committee recommended that the phase 2 trial proceed to its final analysis without modifications while confirming the favorable safety profile of ELI-002 7P.

The investigational immunotherapy ELI-002 7P produced robust T-cell responses and expansion of KRAS mutation-specific T cells among patients with KRAS-mutated pancreatic ductal adenocarcinoma (PDAC), according to findings from the phase 2 AMPLIFY-7P trial (NCT05726864) presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting.1

Among 90 patients who were evaluable at baseline and after treatment, KRAS mutation-specific T cell responses occurred in 98.9% (n = 89/90) with an average fold-change in T cell numbers of 145.3 times higher than baseline. Additionally, 80.0% (n = 72/90) had max T cell fold-change responses of more than 9 times higher vs baseline.

Phase 2 data showed a CD4 and CD8 response rate of 85.0%, exceeding a rate of 75.0% as observed in the phase 1 portion of the trial. The treatment in the phase 2 portion of the trial produced a response rate of 67.4% across all 7 KRAS mutation antigens and a response rate of 87.6% for patient tumor antigens compared to 50.0% and 83.3%, respectively, in the phase 1 portion. ELI-002 7P also exhibited positive T cell responses to 85.7% (n = 540/630) of immunotherapy antigens.

Investigators collected blood from 89 patients who underwent immunization with ELI-002 7P to conduct high resolution HLA typing via next-generation sequencing. Findings showed that patient HLA background was not related to KRAS mutation-specific T cell responses with ELI-002 7P based on no observed relationships between HLA allele and T cell fold-change.

The study investigators noted that the final analysis of disease-free survival (DFS), the trial’s primary end point, is expected to take place in the fourth quarter of 2025. This analysis will explore how DFS and overall survival (OS) outcomes correlate with T cell responses.

“We are highly encouraged by the strength and breadth of the T-cell immunogenicity data emerging from the ongoing phase 2 AMPLIFY-7P trial. Importantly, the robust [KRAS mutation]-specific responses were observed in patients with a highly diverse HLA background, underscoring the potential of ELI-002 7P to benefit a broad population of patients with KRAS-mutant pancreatic cancer,” Christopher Haqq, MD, PhD, executive vice president, head of Research and Development, and chief medical officer at Elicio Therapeutics, the developers of ELI-002 7P, stated in a press release.2 “These findings are consistent with our phase 1 results, where T-cell responses correlated strongly with clinical activity in [patients with] minimal residual disease–positive [status], and they further reinforce our confidence as we look ahead to the event-driven final [DFS] analysis.”

Investigators of the phase 1/2 evaluated the efficacy and safety of ELI-002 7P immunotherapy as adjuvant treatment for patients with different solid tumors harboring KRAS or NRAS mutations.3 In a cohort of those with KRAS-mutated PDAC, patients were randomly assigned 2:1 to receive ELI-002 7P (n = 90) or standard of care with observation (n = 45). Patients received ELI-002 7P in an 8-week priming period followed by 8 weeks of observation and 4 weeks of boost dosing.

The trial’s primary end point was DFS. Secondary end points included biomarker response, OS, overall response rate per iRECIST criteria, and safety. Exploratory end points included direct ex vivo T cell outcomes, fold change from baseline, CD4 and CD8 T-cell responses, and responses to KRAS mutation variants.

Patients 18 years and older with KRAS- or NRAS-mutated solid tumors, negative screening results for recurrent disease, and an ECOG performance status of 0 or 1 were eligible for enrollment on the trial. Those with tumor mutations for which specific therapy is already approved, known brain metastases, and use of immunosuppressive drugs were ineligible for study entry.

An independent data monitoring committee recommended that the phase 2 trial proceed to its final analysis without modifications while confirming the favorable safety profile of ELI-002 7P.

References

1. McNeil LK, Perry JR, Snyder JP, et al. AMPLIFY-7P phase 2: T cell responses induced by ELI-002 7P, a lymph node-targeted amphiphile therapeutic cancer vaccine in patients with KRAS mutated pancreatic ductal adenocarcinoma. Presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting; November 7-9, 2025; National Harbor, MD. Abstract 1317.
2. Elicio Therapeutics reports robust, cytolytic mKRAS-specific T cell responses across diverse patient HLA in ongoing phase 2 AMPLIFY-7P trial of ELI-002 7P and new ELI-004 preclinical data at SITC. News release. Elicio Therapeutics, Inc. November 7, 2025. Accessed November 11, 2025. https://tinyurl.com/578v73pj
3. A study of ELI-002 7P in subjects with KRAS/NRAS mutated solid tumors (AMPLIFY-7P). ClinicalTrials.gov. Updated August 19, 2025. Accessed November 11, 2025. https://tinyurl.com/4zace83s