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Elicio Therapeutics Announces Updated Phase 1 Clinical Trial Results of ELI-002 2P, a Cancer Vaccine Targeting KRAS-Mutant Tumors, Presented at the European Society for Medical Oncology Immuno-Oncology CongressELI-002 is a cancer vaccine based on the company's lymph node-targeting amphiphilic (AMP) technology., used in this clinical trialELI-002 2Pis ELI-002Two-peptide formulation, containing peptide antigens targeting two KRAS mutants. Enrolled patientsFor patients who still have circulating tumor DNA (ctDNA) and/or residual serum tumor biomarkers after receiving standard local treatmentKRASPatients with gene mutation-driven colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC) face a higher risk of disease recurrence.

The Phase 1 trial, named AMPLIFY-201, is a multicenter, open-label, dose-escalation Phase 1 study designed to evaluate the safety and tolerability of ELI-002 2P. The trial enrolled a total of 25 patients, including 20 PDAC patients and 5 CRC patients. All patients underwent successful tumor resection surgery.But assessed as high risk of recurrence based on minimal residual disease (MRD) status.The tumor carries two common KRAS mutations (G12D and G12R).

As of September 24, 2024:

• The median recurrence-free survival (mRFS) was 16.3 months for 25 patients treated with doses ranging from 0.1 mg to 10.0 mg of ELI-002 2P. Among them, the mRFS has not been reached for patients (n=13) with T-cell responses above the median value, while the mRFS was 4.0 months for patients (n=12) with T-cell responses below the median value (HR=0.226; p=0.0184).

• The mRFS for the PDAC subgroup (n=20) was 15.3 months, and for the CRC subgroup (n=5) was 16.3 months, consistent with the entire cohort.

• The median overall survival (mOS) for the entire study cohort and the PDAC subgroup was 28.9 months, which is better than the historical PDAC control group. The mOS for the CRC subgroup (n=5) has not yet been reached.。

• Amplification of KRAS mutation-specific T cells and reduction in tumor biomarkers were observed in the majority of patients.

• In terms of safety, ELI-002 2P was well-tolerated, with no grade 3/4 treatment-related adverse events, dose-limiting toxicity (DLT), or cytokine release syndrome observed.

ELI-002 is the core candidate product of Elicio Therapeutics, Inc.,This is a novel class of cancer vaccines under research, specifically targetingKRASCancer Driven by Gene Mutations. ELI-002 Contains Two Key Components: KRAS Mutant Peptide Antigens Modified with AMP Technology and an AMP-Modified Oligodeoxynucleotide Adjuvant, ELI-004.

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