August 11, 2025—A universal, off-the-shelf vaccine targeting KRAS gene mutations has shown promising results in an early-stage clinical trial, potentially reducing recurrence rates for pancreatic cancer, one of the deadliest and hardest-to-treat cancers. The Phase 1 trial results, published Monday in Nature Medicine, mark an important milestone in post-treatment cancer care.
Pancreatic cancer remains a serious medical challenge, with a five-year survival rate of about 13% and recurrence rates as high as 80% despite surgery and chemotherapy. The experimental vaccine, known as ELI-002 2P, is designed to train the immune system to detect and destroy cancer cells carrying KRAS mutations, genetic changes found in about 90% of pancreatic cancers and 40% of colorectal cancers.
Strong Immune Responses in High-Risk Patients
The trial included 20 patients with pancreatic cancer and 5 with colorectal cancer. All had completed standard treatments, typically surgery followed by chemotherapy, but still showed signs of microscopic residual disease, meaning a small number of cancer cells remained undetected by imaging scans.
Over six months, participants received up to six priming doses of the vaccine, with 13 also receiving booster shots. Results showed that 85% of participants developed an immune response to KRAS mutations. Roughly two-thirds produced a strong enough response to potentially eliminate the remaining cancer cells, significantly lowering their risk of recurrence.
An unexpected benefit was also observed: nearly 70% of participants developed immune responses to additional tumor targets not included in the vaccine, suggesting a broader activation of the immune system. Some patients, described by researchers as “super-responders,” mounted exceptionally strong immune defenses and experienced the best outcomes. Among pancreatic cancer patients, average overall survival reached 29 months, while recurrence-free survival exceeded 15 months—both figures higher than typically reported for surgically treatable cases.
Breaking New Ground in Cancer Vaccine Design
Unlike many cancer vaccines under development, which are personalized to each patient’s tumor profile, ELI-002 2P is a “one-size-fits-all” formulation. This approach eliminates the need for complex and time-consuming custom manufacturing, potentially making it faster and more affordable to deliver.
The vaccine uses lipophilic peptides—short amino acid chains with a lipid “tail” that helps them lodge in lymph nodes, where immune cells are activated. “The critical step is engaging an immune response,” said Dr. Zev Wainberg, co-director of the UCLA gastrointestinal oncology program and a lead investigator on the trial.
Experts note that developing cancer vaccines has historically been difficult because cancer cells often resemble healthy cells, making it challenging to find safe yet effective targets. Recent advances in mRNA technology, faster genetic sequencing, and improved vaccine delivery systems are now enabling researchers to revisit this strategy with greater success.
Next Steps and Broader Implications
The research team is currently conducting a larger, randomized Phase 2 trial to evaluate the vaccine’s long-term effectiveness and compare it with standard monitoring. If further studies confirm its benefits, ELI-002 2P could be used to help prevent recurrence in multiple KRAS-driven cancers, including colorectal cancer.
“This is one of the first real signs that targeting KRAS with a universal vaccine might be possible for treating pancreatic cancer,” said Dr. Stephanie Dougan, associate professor of cancer immunology at the Dana-Farber Cancer Institute. “For a cancer as aggressive as pancreatic, this is an exciting step forward.”
While more evidence is needed before the vaccine can be widely adopted, the Phase 1 results suggest that a universal approach to cancer vaccination could become a valuable addition to standard treatment, offering new hope to patients facing some of the most lethal forms of the disease.
