Clinical Trial Reveals Off-the-Shelf Cancer Vaccine Extending Lifespans, According to Research Findings
In a groundbreaking development, a new cancer vaccine named ELI-002 is showing promising results in the treatment of pancreatic and colorectal cancers driven by KRAS mutations. Developed by Elicio Therapeutics, this vaccine uses AMP-modified mutant KRAS peptide antigens to stimulate strong, durable immune responses that target cancer-driving mutations.
The initial phase 1 trial (AMPLIFY-201) of the two-peptide formulation ELI-002 2P has yielded encouraging results. Patients showed a median relapse-free survival of 16.33 months and a median overall survival of 28.94 months, significantly longer than historical norms. Notably, patients who developed strong mutant KRAS (mKRAS)-specific T cell responses had the greatest benefit, with some groups yet to reach median relapse-free or overall survival, indicating durable responses.
ELI-002 combines AMP-modified mutant KRAS peptides with an AMP-modified CpG oligodeoxynucleotide adjuvant in an off-the-shelf subcutaneous formulation. This design aims to trigger both CD4+ and CD8+ T cell responses to mutant KRAS antigens, and evidence of antigen spreading to patient-specific neoantigens was observed.
Looking ahead, enrollment for the phase 2 study of the ELI-002 7P formulation—targeting a broader set of seven of the most common KRAS mutations seen in about 25% of solid tumors including pancreatic cancer—has been completed. The AMPLIFY-7P trial successfully passed an interim analysis for safety and efficacy, and the final disease-free survival analysis is expected in Q4 2025, with full results anticipated in 2026.
The significance of this vaccine lies in its ability to "program" the immune system to directly target cancer-driving mutations with precision and without the complexity of fully personalized vaccines. This is particularly significant for pancreatic cancer, which has had very limited effective therapies and high rates of recurrence.
In the latest trial, the researchers tested ELI-002 on 25 patients, 20 with pancreatic cancer and 5 with colorectal cancer, who had residual cancer cells lingering in their blood after standard treatment. People with pancreatic cancer vaccinated with ELI-002 2P lived free of cancer recurrence for 15 months on average. Approximately 85% of people generated an immune response to the two mutated KRAS proteins targeted by the vaccine, and two-thirds of people had a strong immune response to the targeted KRAS proteins.
The experimental vaccine ELI-002 is being developed for recurring pancreatic and colorectal cancer. Wainberg and his colleagues have already completed enrollment of a Phase II trial for ELI-0002, with results expected in 2026. The team's findings were published in Nature Medicine. All patients received six doses of ELI-002, aimed at their lymph nodes, while half received booster shots as well.
In summary, ELI-002 shows strong clinical potential as a novel immunotherapy for KRAS-mutant pancreatic and colorectal cancers, with phase 1 data demonstrating improved survival outcomes and phase 2 data expected soon to clarify its efficacy in preventing cancer recurrence and improving long-term survival.
- The new cancer vaccine ELI-002, developed by Elicio Therapeutics, promises to revolutionize the treatment of pancreatic and colorectal cancers by directly targeting cancer-driving KRAS mutations with precision.
- The experimental vaccine, ELI-002, initially tested on 25 patients, demonstrated positive results, with people with pancreatic cancer vaccinated with ELI-002 2P living free of cancer recurrence for an average of 15 months.
- The phase 2 trial for ELI-002, aimed at treating recurring pancreatic and colorectal cancer, has completed enrollment, and the results are expected in 2026.
- The significance of ELI-002 lies in its potential to bypass the complexity of fully personalized vaccines, focusing instead on stimulating strong, durable immune responses to combat chronic diseases like cancer.
- This novel immunotherapy's potential extends beyond science fiction, offering hope for people living with health-and-wellness challenges, including those battling chronic diseases like cancer, through innovative therapies and treatments.
