Overview of the Phase 1 Cancer Vaccine Study

This recently published phase 1 clinical trial studied an experimental cancer vaccine called ELI-002 2P, designed to target KRAS mutations found in pancreatic and colorectal cancers. The trial included 25 participants:

  • 20 with pancreatic cancer
  • 5 with colorectal cancer

Standard Treatment Before the Vaccine

All participants had previously undergone standard treatments such as:

  • Surgery
  • Chemotherapy
    Despite these treatments, they remained at high risk for recurrence—with minimal residual disease detected.

Vaccine Details

The ELI-002 2P vaccine:

  • Is described as “off-the-shelf”, meaning it’s not individually personalized, but can be mass-produced and administered quickly.
  • Targets common KRAS mutations (KRAS-G12D and KRAS-G12R) found in these cancers.
  • Delivered as six priming doses, injected around lymph nodes to boost cancer-specific immune responses.

Key Results from the Study

  • About 85% (21 out of 25 participants) mounted an immune response to the KRAS mutations.
  • Two-thirds of patients (about 68%) developed strong, vaccine-specific T cell responses—both CD4+ (helper) and CD8+ (killer) T cells.
  • Patients with stronger T cell responses lived longer and had a longer recurrence-free survival:
    • Average overall survival: Nearly 29 months post-vaccination
    • Average recurrence-free survival: Over 15 months
  • The vaccine was well tolerated, with mild side effects like soreness and fatigue, and no serious adverse events.

Scientific Impact

  • The trial provides early evidence that off-the-shelf vaccines like ELI-002 2P can activate durable anti-tumor immunity in high-risk patients, especially those who have already completed standard treatments. This is notable because targeting KRAS mutations has been a long-standing challenge in oncology development.
  • Larger, randomized phase 2 trials are now ongoing to validate these findings and determine whether immune response improvements translate into significantly better long-term outcomes.

Resources

Illustration how a cancer vaccine primes T-cells to recognize and attack cancer cells

https://clinicaltrials.gov/study/NCT04853017

Targeting mKRAS With ELI-002 | Elicio Therapeutics
See how our lead candidate is engineered to target a broad spectrum of difficult-to-treat cancers.