Pancreatic and colorectal cancers driven by KRAS mutations remain among the most difficult cancers to treat. Even after surgery and chemotherapy, many patients face recurrence within months. Now, a new therapeutic vaccine is showing early signs of hope—and could represent a major step forward in preventing cancer from returning.
What Is the ELI-002 Vaccine?
The investigational vaccine, known as ELI-002, was designed to train the immune system to recognize and attack cancer cells carrying KRAS mutations. These mutations are found in up to 93% of pancreatic cancers and roughly 50% of colorectal cancers, making them one of the most important cancer drivers.
Unlike personalized vaccines that must be custom-built for each patient, ELI-002 is an “off-the-shelf” vaccine. This means it could be produced more quickly, at larger scale, and at a lower cost—potentially making it more accessible to patients if proven effective.
Early Clinical Trial Results
The first human trial of ELI-002, called AMPLIFY-201, enrolled 25 patients with pancreatic or colorectal cancer. All had undergone surgery and standard therapy but were still at high risk of recurrence.
The results were promising:
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More than 80% of patients developed strong immune responses specifically against KRAS-mutated cancer cells.
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Tumor DNA in the blood cleared completely in six patients, signaling that minimal residual disease may have been eliminated.
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At nearly 20 months of follow-up, patients with strong immune responses lived significantly longer without relapse compared to those with weaker responses.
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Importantly, the vaccine was well-tolerated, with no serious treatment-related side effects reported.
Another encouraging finding was “antigen spreading”—in two-thirds of patients, the immune system expanded its attack to additional cancer targets beyond those included in the vaccine. This suggests ELI-002 may not only direct the immune system against specific KRAS mutations but also help it broaden its defense against cancer recurrence.
Voices of Hope and Caution
Cancer experts are calling the results both exciting and preliminary. Many note that KRAS-driven cancers are typically considered “immune cold,” meaning they rarely provoke a strong immune response. To see robust T-cell activity in this setting is a meaningful milestone.
At the same time, researchers emphasize that these are early findings from a small, single-arm study. Larger, randomized clinical trials will be needed to prove whether the vaccine can truly improve survival outcomes for patients.
What’s Next
A larger phase 2 clinical trial of ELI-002 is already underway, testing an expanded version of the vaccine in more than 100 pancreatic cancer patients. Results from that study are expected in the coming years and will be critical in determining whether this approach can become part of standard care.
The PRECEDE Foundation’s Perspective
At the PRECEDE Foundation, we believe progress against pancreatic cancer comes from steady steps forward—through early detection, innovative treatments, and global collaboration. While it is too soon to call ELI-002 a breakthrough, these early data provide real hope that targeting KRAS mutations could one day help patients live longer, healthier lives after surgery.
We remain committed to supporting cutting-edge research, advocating for patient access to new therapies, and ensuring that every advance brings us closer to changing the outlook for pancreatic cancer.
Read the full article on MedScape here.
