Elicio announces publication of ELI-002 updated AMPLIFY-201 Phase 1 data

Elicio Therapeutics (ELTX) announced the publication of follow-up data from the Phase 1 AMPLIFY-201 study evaluating ELI-002 in the peer-reviewed scientific journal, Nature Medicine. The article, entitled, “Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: Phase 1 AMPLIFY-201 trial final results,” highlights that with extended follow-up, more than two-thirds of participants whose T cell responses exceeded the antitumor efficacy threshold experienced a significantly reduced risk for relapse or death. Key Findings: 25 adjuvant-stage patients with solid tumors were enrolled for treatment based on positive for minimal residual mKRAS disease after locoregional treatment, with data reported through September 24, 2024. Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients, including both CD4+ and CD8+ T cell responses in 71% of patients, and 6/6 patient treated at the recommended Phase 2 dose; the induction of both CD4+ and CD8+ T cells correlated with overall tumor biomarker response. Tumor biomarker responses were observed in 21/25 patients, with complete biomarker clearance observed in 6/25 patients, as determined by tumor-informed circulating tumor DNA analysis. At 19.7 months median follow-up, the median relapse-free survival was 16.33 months, and the median OS was 28.94 months for the 25-patient cohort.