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Off-The-Shelf KRAS Vaccine Yields Robust T-Cell Responses and Survival Benefit

A larger randomized Phase 2 trial aims to confirm whether the vaccine can prevent recurrence after surgery.

NIH Image Gallery National Institutes of Health (NIH) Follow Pancreatic Desmoplasia As shown here, pancreatic cancer is associated with a vast desmoplastic reaction in which the connective tissue around the tumor thickens and scars. Tests similar to the one depicted here help distinguish between "good" and "bad" stromal reactions. Researchers hope this could allow the design of therapies that will reprogram tumor-stromal interaction. Cancerous cells are in red; nuclei are in blue; stroma/desmoplasia is in cyan; and stroma-specific markers are in yellow and green while marker overlays appear white. This image was originally submitted as part of the 2016 NCI Cancer Close Up project and selected for exhibit. See also visualsonline.cancer.gov/closeup2016. Credit :Neelima Shah and Edna Cukierman, Fox Chase Cancer Center, National Cancer Institute, National Institutes of Health https://www.flickr.com/photos/nihgov/26645704270/in/photolist-GAAcyj-GAACEb-VKAEBG-FZk4ue-KFjbez-GXJM1U/
Researchers reported early clinical and preclinical results showing that experimental mRNA and nanoparticle vaccines produced measurable immune responses against pancreatic cancer and glioblastoma.
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Overview

  • The Phase 1 study of ELI-002 2P in 25 patients with pancreatic and colorectal cancers showed that 85% mounted immune responses against common KRAS mutations.
  • Approximately 68% of participants achieved strong T-cell activation, correlating with an average recurrence-free interval of over 15 months and 29 months overall survival in pancreatic cancer patients.
  • The vaccine’s AMP/lipophilic-peptide design enhances delivery to lymph nodes, enabling an off-the-shelf approach without personalized manufacturing.
  • Independent experts caution that the small, uncontrolled trial requires confirmation through larger randomized studies to validate clinical benefit and understand patient variability.
  • Enrollment has concluded for the 144-patient Phase 2 trial, which will compare ELI-002 2P against standard care in KRAS-driven cancers, with results expected following follow-up.