ELI-002 7P Shows Potential to Address Unmet Need in Pancreatic Ductal Adenocarcinoma

The investigative multi-peptide vaccine ELI-002 7P elicited robust mutant KRAS (mKRAS)–specific T-cell responses across a broad range of human leukocyte antigen (HLA) types in patients with pancreatic ductal adenocarcinoma (PDAC), according to preliminary analyses from the ongoing phase 1/2 AMPLIFY-7P trial (NCT05726864).1

Among 89 patients treated with ELI-002 7P, a total of 1,132 unique primary class I and II HLAs were identified, demonstrating significant genetic diversity within the study population.

Of note, data shared in September 2025 demonstrated robust activation of mKRAS-specific CD4 and CD8 T-cell responses with ELI-002 7P at the 4.9-mg dose.2 Among evaluable patients (n = 90), 99% achieved measurable mKRAS-specific T-cell activation, with a mean 145.3-fold and median 44.3-fold increase over baseline (range, 2.13-1310).

According to Elicio Therapeutics, the drug’s developer, these T-cell responses were consistent with observations made in phase 1 trials of ELI-002, and are aligned with a growing body of evidence supporting the presentation of mKRAS antigens across a wide range of HLA subtypes.1 A recent analysis published in Cell Reports Methods similarly identified mKRAS G12D- or G12V-specific T cells in all healthy donors screened across diverse HLA backgrounds (n = 20), reinforcing the potential applicability of ELI-002 7P to a large population of patients with PDAC.

“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, potentially addressing a key unmet need and expanding the potential market opportunity,” Robert Connelly, chief executive officer of Elicio, commented in a news release. “Our observations build on past data to show that the majority of patients express mKRAS-presenting HLAs, likely enabling T-cell recognition in most patients. These encouraging findings highlight the potential for ELI-002 7P to benefit a broader spectrum of patients, which may extend the reach of immunotherapy to more individuals and address a critical unmet need.”

What Is the Mechanism of ELI-002?

ELI-002 is a structurally novel investigational AMP cancer immunotherapy designed for tumors driven by KRAS mutations. The therapy consists of AMP-modified mKRAS peptide antigens and an AMP-modified CpG oligodeoxynucleotide adjuvant (ELI-004), formulated for off-the-shelf subcutaneous (SC) administration.

Two formulations have been evaluated:

• ELI-002 2P (2-peptide), which was assessed in the phase 1 AMPLIFY-201 trial (NCT04853017) in patients with high-risk solid tumors driven by KRAS mutations following surgery and chemotherapy
• ELI-002 7P (7-peptide), which is currently under investigation in the phase 2 portion of AMPLIFY-7P in patients with PDAC driven by KRAS mutations.

The 7-peptide design aims to expand immune recognition to 7 prevalent KRAS mutations found in approximately 25% of solid tumors.

What Is the Design of the AMPLIFY-7P Trial?

In the phase 2 portion of AMPLIFY-7P, patients with resected KRAS-mutant PDAC (n = 158) were enrolled across 28 US sites and were randomly assigned 2:1 to receive adjuvant ELI-002 7P or standard-of-care observation following local therapy, surgery, and chemotherapy with or without radiation. 3

Dose selection occurred during the phase 1a portion of the trial, during which patients received weekly SC 10 mg doses of ELI-002 Amph-CpG-7909 administered alongside either 1.4 mg or 4.9 mg of the 7-peptide formulation for 4 weeks, followed by biweekly dosing for 4 weeks during the immunization phase. After a 2-month off-treatment window, booster immunizations were administered weekly for 4 additional weeks. The 4.9-mg dose was selected for continued evaluation in phase 1b and phase 2. Phase 1b included patients with colorectal cancer, and the phase 2 portion additionally enrolled patients who were minimal residual disease negative.

The primary end point of the phase 2 portion of the AMPLIFY-7P trial was disease-free survival. Secondary end points included overall survival, biomarker reduction or clearance rate, and safety.

What Additional Data Have Been Reported From AMPLIFY-7P?

Approximately 80% of patients in AMPLIFY-7P exceeded an activity-associated threshold of a 9.5-fold response increase.2 When CD4 and CD8 responses were jointly considered, 85.0% of patients surpassed this threshold. Including responses to all 7 mKRAS antigens or patient-specific tumor antigens, the proportion above threshold ranged from 67.4% to 87.6%.

Notably, an independent data monitoring committee recommended continuation of AMPLIFY-7P in August 2025 following a planned interim safety and efficacy review.4 Investigators remain blinded to full phase 2 clinical efficacy results, including correlations between T-cell response and antitumor outcomes.

References

1. Elicio Therapeutics reports robust T cell responses across diverse HLA backgrounds in ongoing phase 2 AMPLIFY-7P trial. News release. Elicio Therapeutics. October 27, 2025. Accessed October 27, 2025. https://elicio.com/press_releases/elicio-therapeutics-reports-robust-t-cell-responses-across-diverse-hla-backgrounds-in-ongoing-phase-2-amplify-7p-trial-2/
2. Elicio Therapeutics reports ELI-002 7P achieved robust mKRAS-specific T cell responses in 99% of evaluable patients in ongoing phase 2 AMPLIFY-7P trial. News release. Elicio Therapeutics. September 17, 2025. Accessed October 27, 2025. https://elicio.com/press_releases/elicio-therapeutics-reports-eli-002-7p-achieved-robust-mkras-specific-t-cell-responses-in-99-of-evaluable-patients-in-ongoing-phase-2-amplify-7p-trial/
3. A study of ELI-002 7P in subjects with KRAS/NRAS mutated solid tumors (AMPLIFY-7P). ClinicalTrials.gov. Updated August 19, 2025. Accessed October 27, 2025. https://clinicaltrials.gov/study/NCT05726864
4. Elicio Therapeutics announces positive recommendation by IDMC to continue ELI-002 7P randomized phase 2 study in pancreatic cancer without modifications to final analysis. News release. Elicio Therapeutics. August 5, 2025. Accessed October 27, 2025. 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/