A novel “off-the-shelf” vaccine, ELI-002 2P (Elicio Therapeutics), has delivered encouraging results in a phase 1 study for patients with pancreatic and colorectal cancers driven by KRAS mutations. Nearly 20–25% of solid tumors carry KRAS mutations — including 93% of pancreatic ductal adenocarcinomas and 50% of colorectal cancers — making the implications potentially wide-reaching.
Key Takeaways
1. Encouraging survival outcomes
Patients with strong T-cell responses to mutant KRAS saw no median recurrence-free or overall survival reached after ~20 months of follow-up. By contrast, weaker responders had RFS of just 3 months and OS of 16 months.
2. Minimal toxicity, strong immune activation
No grade ≥3 adverse events were reported, and 84% of patients mounted a KRAS-specific immune response. The most common side effect was an injection-site reaction.
3. Durable results
Among strong responders, 65% showed no radiographic progression, and six patients cleared minimal residual disease (three with pancreatic cancer, three with colorectal cancer).
4. Wider implications
Lead investigator Zev A. Wainberg, MD (UCLA) noted that the vaccine’s approach could extend beyond pancreatic cancer, potentially benefiting colorectal and other KRAS-driven tumors.
5. Next steps
A randomized phase 2 trial in ~150 PDAC patients has been completed, with results expected in Q1 2026. If survival benefits hold, the vaccine could shift standard care in KRAS-mutant cancers.