The TeloVac trial was sponsored by The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK and was funded by Cancer Research UK. The trial was conducted through the Cancer Research UK Liverpool Clinical Trials Unit and supported by GemVax, a subsidiary of KAEL-GemVax. The trial recruited 1062 patients in 52 centres throughout the UK. There was no significant difference in overall survival between the groups that received the vaccine and the control group receiving chemotherapy. The trial also included an ambitious program of translational research, which is still undergoing evaluation. Initial results indicate that the vaccine resulted in a significant anti-inflammatory response that correlates well with new research being conducted by the parent company, Kael-GemVax. Additionally, two possible biomarkers for an increased survival in response to the vaccine in a subgroup of patients were identified.
J.P. Neoptolemos (Cancer Research UK Liverpool Clinical Trials Unit Director and National Institute for Health Research Pancreas Biomedical Research Unit, University of Liverpool, UK) commented on the trial:
“This large trial in a needy and difficult group of patients was extremely well received and recruited well ahead of target providing a wealth of clinical and scientific information. Although the two vaccine arms did not show an overall significant survival advantage compared to background chemotherapy, we were delighted to see that the vaccine was well tolerated without significant side effects. We were very pleased that using the combination of gemcitabine and capecitabine produced such a good one year survival rate.
In general, we have identified that simultaneous vaccination with chemotherapy provides an effective method for generating both an immune response and also promoting an anti-inflammatory effect. We are encouraged by the finding of potential biomarkers that may serve to identify a group of patients that could respond to the vaccine with improved survival. These findings are sufficiently strong to initiate new basic research into the mechanisms of action of the vaccine and test the use of GV1001 in future clinical trials aiming to improve survival of a subgroup of patients using the biomarkers identified in this trial”.
Michelle Kim, Kael-GemVax CEO said “While we are disappointed that the vaccine did not result in a significant survival advantage, we are encouraged by the finding of two possible biomarkers that may predict response to the vaccine and increased survival in a subgroup of patients. Furthermore, we are excited to see that an anti-inflammatory effect was seen in the trial, a finding that reinforces research that is currently being conducted at Kael-GemVax”.