Elicio Therapeutics, Inc. announced the publication of data from the Phase 1 (AMPLIFY-201) study of ELI-002 2P in Nature Medicine. The paper, "Lymph Node Targeted, mKRAS-specific Amphiphile Vaccine in Pancreatic and colorectal Cancer: The phase 1 AMPLIFY-201 Trial", details expanded and updated results originally presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2023 AACR Special Conference on Pancreatic Cancer. Nature Medicine Publication Highlights: The data is as of September 6, 2023, based on 25 patients with solid tumors (20 pancreatic, 5 colorectal) who were positive for minimal residual mKRAS disease after locoregional treatment.

Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%; 59% both CD4+ and CD8+). Tumor biomarker responses were observed in 21/25 patients (84%) and biomarker clearance in 6/25 patients, as determined by tumor-informed circulating tumor DNA (24%; 3 pancreatic, 3 colorectal). At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months.

Efficacy correlated with T cell response (= versus < median: 12.75-fold over baseline): Median tumor biomarker reduction was -76.0% compared to -10.2% in above versus below median T cell responders, respectively (p<0.0014). Median RFS was not reached compared to 4.01 months in above versus below median T cell responders, respectively (HR 0.14, 95% CI 0.03 to 0.63, p=0.0167). Patients with greater than median T cell response had an 86% reduction in the risk of progression or death.

The association of RFS with T cell response was not correlated to baseline prognostic variables including tumor stage, recovery from prior cytotoxic therapy as assessed by absolute neutrophil count or immune system subsets such as %CD4+ or %CD8+ of CD3+ lymphocytes. RFS was shorter in patients who began treatment with a low absolute lymphocyte count. No safety concerns were identified, and no dose limiting toxicities and no = grade 3 treatment related adverse events were observed.