Results of an experimental pancreatic cancer vaccine targeting the KRAS gene mutation were published in Cancer Discovery, a journal published by the American Association for Cancer Research. These findings are based on a Phase I clinical trial involving 20 participants.
First demonstration of immune response
The study authors stated that the data obtained represents 'the first demonstration in humans' that a vaccine targeting the KRAS gene mutation can 'safely induce long-term immune responses, potentially preventing cancer development in at-risk individuals.'
Mechanism of action and study
The research was conducted by scientists from the Kimmel Cancer Center at Johns Hopkins University and the Skip Viragh Center for Pancreatic Cancer in the United States. Pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer, is an aggressive tumor often diagnosed at late stages and has a low five-year survival rate.
Approximately 10% of cases are linked to hereditary predisposition caused by pathogenic mutations in specific susceptibility genes that are inherited. Mutations in the KRAS gene are present in most cases of pancreatic cancer and precancerous lesions. According to the findings, the vaccine allows the immune system to recognize and destroy cells carrying these mutations before they turn malignant.
Conducting the clinical trial
The study evaluated mKRAS-VAX, a peptide vaccine targeting six of the most common KRAS gene mutations found in pancreatic cancer. A total of 20 participants, who had a hereditary predisposition to this tumor and an identified pancreatic anomaly via imaging, received the vaccine between April 2022 and February 2026.
The vaccine was administered in four doses over 13 weeks, and participant progress was monitored through blood tests and subsequent examinations. The research team concluded that 18 out of 20 participants (90%) developed a significant immune response, demonstrating an average increase in T-cell responses specific to the mutated KRAS gene by 18.2 times, indicating successful activation of immune cells capable of recognizing mutations.
Safety and limitations
After a median follow-up period of 16.5 months, none of the participants developed pancreatic cancer or a high-risk pancreatic lesion requiring surgical removal. The study also indicates that all side effects were classified as mild or moderate, including fatigue and flu-like symptoms.
Researchers emphasized that the primary goal of the study was to assess safety and immune response, not to determine the vaccine's ability to prevent pancreatic cancer. They also warned that the limited sample size and relatively short follow-up period restrict conclusions about effectiveness in clinical practice.
Prospects for further research
Elizabeth Jaffy, one of the lead co-authors of the study, noted: 'This is just the beginning, but the results suggest that the immune system is being activated,' adding that it is 'a good start toward prevention, something no one has thought about before.'