Cancer treatment has long sought ways to harness the immune system to recognize and destroy tumor cells. A new development led by Memorial Sloan Kettering Cancer Center (MSK) offers encouraging evidence that an “off-the-shelf” vaccine targeting KRAS mutations may help prevent recurrence in patients with colorectal or pancreatic cancers.
Why KRAS Is a Critical Target
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The KRAS gene plays a central role in cell signaling and growth. Mutations in KRAS drive tumor development in many cancers.
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In pancreatic cancer, nearly 90–95% of tumors harbor a KRAS mutation; in colorectal cancer, about 50% carry such mutations.
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Historically KRAS has been considered “undruggable,” but recent advances (e.g., KRAS G12C inhibitors) have shown that certain variants can, in fact, be targeted.
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The MSK team’s vaccine focuses on KRAS G12D and G12R mutations — variants that occur frequently in pancreatic and colorectal cancers but weren’t addressed by earlier KRAS-inhibitor therapies.
What Makes This Vaccine Strategy Unique
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Unlike personalized cancer vaccines that require custom production, this vaccine—named ELI-002 2P—is an off-the-shelf option.
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The vaccine is designed with peptides (small protein fragments) that bind to albumin at the injection site, helping target delivery to nearby lymph nodes to stimulate immune responses.
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It is administered in multiple injections in a two-phase schedule: a primary series followed by a booster series.
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In early testing, side effects were relatively mild and tolerability appeared better than standard therapies like chemotherapy or radiation.
Clinical Trial Findings So Far
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A Phase 1 trial enrolled 25 patients with pancreatic or colorectal cancers at high risk of recurrence.
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After ~20 months of follow-up:
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About two-thirds of patients mounted a measurable immune response.
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Patients with stronger immune responses experienced longer recurrence-free and overall survival.
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Average survival was nearly 29 months, with recurrence-free survival over 15 months — encouraging compared to historical benchmarks.
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In some patients, the immune response broadened to recognize additional KRAS mutations unique to their tumors.
Next Steps: Phase 2 and Beyond
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An expanded Phase 2 trial began in December 2023, enrolling about 135 patients with pancreatic cancer and high recurrence risk.
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The study aims to confirm whether the vaccine’s immune effects translate into delayed recurrence and longer survival.
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The new formulation in Phase 2 targets a broader set of KRAS mutations.
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Researchers see potential for combining such vaccines with other immunotherapies or targeted drugs for greater impact.
Why This Matters for Patients and Foundations
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Scalability — off-the-shelf vaccines can reach more patients quickly.
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Preventing recurrence — patients in remission may gain long-term protection.
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Combination potential — may complement checkpoint inhibitors or KRAS inhibitors.
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Continued research — philanthropy and patient advocacy will be vital in accelerating progress.
A Note of Caution & Hope
Phase 1 results demonstrate safety and strong immune activation, but larger trials are needed to confirm clinical benefit. Still, this vaccine represents a major step forward in cancer immunotherapy and could be transformative for patients facing pancreatic and colorectal cancers.
About Precede Foundation
Precede Foundation is dedicated to advancing research and awareness in early detection and treatment of pancreatic cancer. By connecting patients, families, researchers, and advocates, we aim to improve outcomes and bring hope to those impacted by this disease.
If you would like to read more about this study, here is the full article on MSK’s website.