ELI-002 (AMPLIFY-201): KRAS-Targeted Amphiphile Vaccine for Minimal Residual Disease

ELI-002 is a therapeutic cancer vaccine from Elicio Therapeutics designed for patients who have undergone surgery for KRAS-mutated cancers but still have minimal residual disease detectable via circulating tumor DNA. The vaccine targets mutated KRAS, an oncogene long considered "undruggable" because of its smooth protein surface, by training T cells to recognize and destroy cells expressing the mutant form. The innovation is the amphiphile delivery platform: peptide antigens are linked to a lipid tail that binds serum albumin, which then traffics the cargo directly into lymph nodes where T-cell priming occurs. This concentrates antigen presentation at the right anatomical site rather than dispersing it through general circulation. The AMPLIFY-201 Phase 1 trial enrolled 25 patients — 20 with pancreatic cancer and 5 with colorectal cancer — all carrying KRAS mutations and circulating tumor DNA positivity after surgery. 84% developed mKRAS-specific T-cell responses, 84% showed biomarker responses, and 24% achieved complete ctDNA clearance. Median relapse-free survival reached 16.33 months in the initial readout and was not yet reached in final data, versus 3.02 months in historical controls. The ongoing Phase 2 AMPLIFY-7P trial reports 99% T-cell response in evaluable pancreatic patients. The approach is significant because KRAS mutations drive about 90% of pancreatic, 30-40% of colorectal, and 25% of lung cancers. A vaccine that works on shared mutant KRAS epitopes could provide an adjuvant therapy applicable across many tumor types, deployed at the post-surgical window where tumor burden is lowest and the immune system has the best chance.