Sylvester receives $1 million to study pancreatic cancer vaccine strategy
A five-year V Foundation-backed project at Sylvester will examine why a KRAS vaccine triggered immune responses but missed its Phase 2 trial’s primary endpoint.
Key Takeaways
- •A V Foundation grant with Dolphins Cancer Challenge support will fund five years of research at Sylvester.
- •AMPLIFY-7P missed its primary disease-free-survival endpoint, although 89 of 90 evaluable vaccine recipients developed KRAS-specific T-cell responses.
- •The team will compare tumor samples and test combinations in preclinical work before a planned Phase 1 trial.
A new $1 million project at Sylvester Comprehensive Cancer Center will study why a pancreatic cancer vaccine generated immune responses but missed the Phase 2 trial’s primary disease-free-survival goal.
The five-year award, announced Oct. 23 by the University of Miami Miller School of Medicine, is funded by the V Foundation with support from the Dolphins Cancer Challenge. Gastrointestinal oncologist Peter J. Hosein, M.D., will lead the work at the Miami cancer center, with Jashodeep Datta, M.D., as co-principal investigator. The University’s research announcement says Datta’s lab will lead tumor analysis and planned animal studies. The V Foundation’s grant listing identifies the project as a partnership with the Dolphins Cancer Challenge.
The project follows AMPLIFY-7P, a randomized Phase 2 trial of camupepimut, also called ELI-002 7P. The experimental vaccine targets seven common KRAS mutations. The study, published in Nature Medicine on Oct. 23, did not meet its primary disease-free-survival endpoint. The university report says 89 of 90 evaluable vaccine recipients developed KRAS-specific T-cell responses. That immune response is a biological finding, not evidence that the vaccine prevented recurrence or improved the trial’s primary outcome.
The new work asks what may limit those vaccine-primed immune cells inside pancreatic tumors. Researchers plan to compare archived tumors from vaccinated patients whose cancer returned with recurrent tumors from participants in the trial’s vaccine-naive control group. Molecular analysis and spatial imaging will examine features in and around the tumors that could affect whether T cells reach or destroy cancer cells.
Hosein’s team will also test the vaccine with daraxonrasib, a RAS(ON) inhibitor, with or without nivolumab in preclinical studies. The experiments are intended to examine whether blocking RAS signaling can counter immune suppression in the tumor environment. They are laboratory and animal-model studies, not a treatment being offered to patients.
The project is designed to support a planned multicenter Phase 1 trial for previously treated patients with metastatic pancreatic cancer carrying KRAS mutations. The university has not announced that the trial is open or recruiting. The sequence runs from archived patient samples to preclinical testing before any proposed clinical study.
For Miami, the award adds a five-year research program at Sylvester led by local investigators. Its immediate work is to explain why a vaccine-generated immune response did not translate into the primary clinical benefit measured in AMPLIFY-7P, then test whether a combination approach merits further study.
