Posted: Wednesday, January 8, 2025
Neoantigen DNA vaccines appear to be safe, feasible, and capable of inducing neoantigen-specific immune responses in patients with triple-negative breast cancer, according to the results of a small phase I clinical trial published in Genome Medicine. William E. Gillanders, MD, of Washington University School of Medicine, St. Louis, and colleagues reported that an investigational vaccine created using a platform they developed was well tolerated and stimulated immune responses among high-risk patients with persistent disease after neoadjuvant chemotherapy. The researchers believe these results support further study of this neoantigen DNA vaccine platform in both triple-negative breast cancer and other low-mutation–burden cancers.
“We are excited about the promise of these neoantigen vaccines,” said Dr. Gillanders in a WashU Medicine press release. “We are hopeful we will be able to bring more and more of this type of vaccine technology to our patients and help improve treatment outcomes in patients with aggressive cancers.”
A total of 18 patients with triple-negative breast cancer and persistent disease on surgical pathology after neoadjuvant chemotherapy were included in the study. Their expressed somatic mutations were first identified by tumor/normal exome sequencing and tumor RNA sequencing. The investigators then used a software suite of neoantigen prediction algorithms they developed to identify and prioritize cancer neoantigens and facilitate patient-specific vaccine design.
Participants received three doses of a neoantigen DNA vaccine that encoded an average of 11 neoantigens per patient (range = 4–20). The researchers reported the vaccines were well tolerated with relatively few adverse events, and neoantigen-specific T-cell responses were induced in 14 of the 18 patients. At a median follow-up of 36 months, recurrence-free survival was 87.5% (95% confidence interval = 72.7%–100%).
Disclosure: Dr. Gillanders reported no conflicts of interest. For full disclosures of the other study authors, visit genomemedicine.biomedcentral.com.