Committee recommends study of pancreatic cancer vaccine continue
AMPLIFY-7P trial is testing ELI-002 7P in people with KRAS-mutant PDAC
An independent committee has recommended that a clinical trial testing the experimental anticancer vaccine ELI-002 7P in people with pancreatic cancer should continue as planned.
The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) is often marked by mutations that affect the KRAS protein. ELI-002 7P is designed to destroy cancer cells by triggering the immune system to attack the mutant protein. Its developer, Elicio Therapeutics, is running a Phase 2 study called AMPLIFY-7P (NCT05726864) to test ELI-002 7P in people with PDAC and KRAS mutations.
Like other clinical trials, AMPLIFY-7P has an independent data monitoring committee, or IDMC, made up of outside experts tasked with periodically reviewing trial data to ensure the study’s integrity and the safety of its participants. In its latest review, the AMPLIFY-7P study’s IDMC recommended the trial continue to its final analysis without any modifications in protocols.
Along with confirming an acceptable safety profile, the IDMC’s analysis included tests for futility, that is, to evaluate if it remains likely the trial will achieve positive results. This is a promising sign for the therapy’s efficacy, according to Elicio.
Encouraging news
“We are encouraged by the IDMC’s recommendation to support the continuation of the AMPLIFY-7P trial as planned, as we believe it indicates that ELI-002 7P has shown preliminary signals of efficacy,” Robert Connelly, CEO of Elicio, said in a company press release.
The study enrolled 144 people with KRAS-mutant PDAC who had already been treated with surgery, chemotherapy, and/or radiation. The participants were randomly assigned to ELI-002 7P — six weekly injections under the skin, then four weekly injections after a two-month break — or to standard-of-care monitoring for signs of disease progression. The main goal is to evaluate the treatment’s effect on rates of survival free from disease. The final results are expected this year.
“We look forward to the final disease-free survival analysis anticipated to occur in the fourth quarter of 2025 and continue to believe that ELI-002 7P has the potential, based on the compelling data generated to date, to offer a new solution to patients facing PDAC in the adjuvant setting,” Connelly said.
Elicio is at work on plans for a Phase 3 clinical trial to further test the vaccine and support its approval. The company has already aligned with the U.S. Food and Drug Administration (FDA) on key elements of the Phase 3 study, said Connelly, who noted Elicio will a meeting with the FDA to “finalize the regulatory strategy for the ELI-002 Phase 3 study,” once the final Phase 2 results are in.
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