A Phase I clinical trial has shown encouraging results for a lymph node-targeted cancer vaccine, ELI-002, designed to prevent relapse in KRAS-mutated pancreatic and colorectal cancers. The vaccine, evaluated in the AMPLIFY-201 trial, displayed an 86% reduction in the risk of relapse or death. T cell responses were observed in 84% of patients, reaching 100% in the two highest dose cohorts, particularly those receiving the recommended Phase II dose of 10mg.
These T cell responses correlated with significant reductions in tumor biomarkers and circulating tumor DNA (ctDNA) clearance. The study also highlighted a median recurrence-free survival that had not been reached in patients with a T cell response level above the median, compared to 4.01 months in those below the median.
Dr. Shubham Pant, the principal investigator, expressed optimism about the vaccine’s potential to help patients avoid relapse, potentially increasing overall survival. The trial showcased a favorable safety profile, with no dose-limiting toxicities, cytokine release syndrome, or severe adverse events reported.
The study is particularly significant for pancreatic cancer patients who remain at risk for relapse post-surgery, especially those positive for ctDNA. The absence of curative options after relapse underscores the urgent need for effective preventive measures.
Looking ahead, a Phase II trial is slated for 2024, utilizing a new formulation of the ELI-002 cancer vaccine, targeting additional KRAS mutations. Preliminary data from the Phase I trial, presented at the ASCO Annual
Meeting and AACR Special Conference on Pancreatic Cancer in 2023, has laid a promising foundation for further advancements in cancer vaccine research. The trial received support from Elicio Therapeutics.