Vaccine Elicits Immune Responses in Pancreatic Cancer

In an announcement, the off-the-shelf vaccine ELI-002 7P elicited strong mKRAS-specific T-cell responses in 89 out of 90, or approximately 99%, of evaluable patients with pancreatic cancer.

The data were announced in a news release issued by Elicio Therapeutics, a clinical-stage biotechnology company that developed the cancer vaccine.

“We are extremely encouraged by the T-cell immunogenicity data from the ongoing phase 2 ELI-002 7P trial,” commented Robert Connelly, Chief Executive Officer of Elicio, in the news release. “The robust T-cell responses observed are highly consistent with our positive phase 1 results and further enhance our confidence in the ongoing phase 2 trial, as T-cell immune responses in phase 1 trials for ELI-002 2P and ELI-002 7P were significantly correlated with clinical activity in minimal residual disease-positive patients. These important data set the stage for the final disease-free survival analysis in the AMPLIFY-7P trial, which is anticipated to occur in the fourth quarter of 2025.”

The phase 2 AMPLIFY-7P clinical trial included both minimal residual disease-positive and -negative patients, meaning those who did and did not have very small trace amounts of cancer remaining that were detectable by a blood test.

How Does ELI-002 Work?

According to the news release, ELI-002 targets cancers driven by mutations in the KRAS gene, which is a driver of many human cancers. The ELI-002 7P iteration of the vaccine is intended to provide an immune response against seven of the most common KRAS mutations found in a quarter of all solid tumors. As previously reported by CURE, the first patient was dosed in the AMPLIFY-7P trial in January 2024.

“This vaccine works like most vaccines hopefully work, which is to engage and stimulate an immune response against a cancer protein, and that includes T-cells and B-cells and all your immune cells to recognize cancer cells as foreign and to engage in the fight against them,” explained Dr. Zev Wainberg in an interview with CURE. Wainberg is the first author of a study on ELI-002 2P, another iteration of the vaccine, which was published in Nature Medicine.

Wainberg is also a professor of medicine at the David Geffen School of Medicine at UCLA and a researcher in the UCLA Health Jonsson Comprehensive Cancer Center.

Dr. Wainberg discussed the significance of the vaccine’s “off-the-shelf” status for patients. “It means it's a vaccine that can be readily and easily available because it doesn't have to be personalized,” he said. “Personalized means that you have to send the tumor in and do a lot of manipulation to create the vaccine. Because the target of interest in this vaccine was a KRAS, which is so ubiquitous among, for example, 90% of pancreas cancer and 50% of colon cancer, because of the high frequency of that, it's a good candidate for an off-the-shelf vaccine.”

Additionally, he explained how this vaccine, if it makes it to market, will address unmet needs for patients. “One of the challenges that's quite unique in pancreatic cancer is that even after the patient gets an operation and gets chemo and radiation, whatever else they're going to do, they still have a very, very high risk of recurrence, and that is quite unique, I would say,” he explained. “It's the highest risk of recurrence after a cancer has been removed compared to any others—breast, colon, lung, you name it. Because of that high risk, they're always, unfortunately, going to have to deal with it again, and sometimes in a fatal way.”

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Reference

1. “Elicio Therapeutics Reports ELI-002 7P Achieved Robust mKRAS-Specific T Cell Responses in 99% of Evaluable Patients in Ongoing Phase 2 AMPLIFY-7P Trial,” by Elicio Therapeutics. News release; Sept. 17, 2025.
2. “First Patient Dosed in Phase 2 Cancer Vaccine Trial,” by Alex Biese. CURE; Feb. 1, 2024. https://www.curetoday.com/view/first-patient-dosed-in-phase-2-cancer-vaccine-trial
3. “Off-The-Shelf Vaccine Elicits Durable Responses in Pancreatic, Colorectal Cancers,” by Alex Biese. CURE; Aug. 13, 2025. https://www.curetoday.com/view/off-the-shelf-vaccine-elicits-durable-responses-in-pancreatic-colorectal-cancers