An experimental therapeutic pancreatic cancer vaccine has demonstrated encouraging results in a clinical evaluation, triggering robust immune responses in the vast majority of trial participants. Developed by biotechnology firm Elicio Therapeutics, the off-the-shelf vaccine known as ELI-002 7P—also referred to as camupepimut—achieved mutant KRAS-specific T-cell responses in 99% of evaluable patients in an ongoing Phase 2 clinical trial.
AMPLIFY-7P Trial Results and Immune System Activation
The findings from the randomized Phase 2 AMPLIFY-7P trial were presented at the European Society for Medical Oncology (ESMO) Congress in Madrid by Dr. Eileen O’Reilly, a medical oncologist and pancreatic cancer specialist at Memorial Sloan Kettering Cancer Center. The study results were also published simultaneously in the scientific journal Nature Medicine.
According to the data, treated patients experienced a median 44.3-fold increase in mutant KRAS-specific T-cell responses from baseline. Among patients evaluated for specific T-cell subsets, 85% generated both CD4 and CD8 responses. Furthermore, these immune responses persisted for at least 46 weeks from baseline in 95.5% of evaluable treated patients, and a selected subset showed responses to additional tumor targets.
“These findings are exciting because they show that there is more than one way to activate immune cells to target pancreatic cancer,” Dr. O’Reilly stated. She co-led the trial alongside Dr. Ben George of the Medical College of Wisconsin and Dr. Christopher M. Haqq of Elicio Therapeutics.
Targeting KRAS Mutations in Solid Tumors
Mutations in the KRAS gene are found in more than 90% of pancreatic cancers and drive several high-prevalence solid tumors. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, which are present in roughly 25% of these cancers.
The vaccine utilizes Elicio’s proprietary Amphiphile (AMP) technology, which aims to enhance the delivery of antigens to the lymph nodes to better educate, activate, and amplify cancer-specific T cells compared to conventional vaccination approaches. Unlike personalized cancer vaccines, which require costly and time-consuming individual manufacturing, an off-the-shelf therapeutic vaccine can be produced in batches and administered to patients with minimal delay.
“Having a vaccine that’s ‘off-the-shelf’ would make it easier, faster, and less expensive to treat a larger number of patients,” Dr. O’Reilly explained, noting that the therapy offers renewed hope for individuals facing a high risk of relapse following surgery and chemotherapy.
Next Steps and Clinical Outlook
Robert Connelly, President and Chief Executive Officer of Elicio, highlighted that the trial results reinforce confidence in camupepimut’s clinical activity. Investigators noted consistent treatment-effect trends across pre-specified patient groups, including individuals both with and without detectable baseline circulating tumor DNA (ctDNA).
As the AMPLIFY-7P trial continues, researchers will continue evaluating long-term clinical outcomes, survival benefits, and antigen spreading, which involves the immune system recognizing additional patient-specific neoantigens beyond the initial mKRAS targets.
