Vxm01 Phase I Study In Patients With Progressive Glioblastoma: Final Results.

2017Background: VXM01 consists of an attenuated Salmonella typhi Ty21a carrying a plasmid encoding for vascular endothelial growth factor receptor (VEGFR)-2. The bacterium is a vector via the oral route of administration carrying the plasmid into the Peyer’s plaques. The vaccine elicits a systemic T-cell response targeting VEGFR-2. This trial examined safety and tolerability, clinical and immunogenic response to VXM01 after at least four vaccinations [106 or 107 colony-forming units (CFU)] in patients with progressive glioblastoma who have failed at least radiochemotherapy with temozolomide. Methods: Patients with progressive operable glioblastoma were subjected to VXM01 in one oral administration each on day 1, 3, 5, and 7. In addition, VXM01 was allowed to be administered in 4-weekly single doses every 4 weeks during the tumor follow-up period after surgery. Follow-up was done by weekly safety laboratories and physical examinations in the treatment period and 12-weekly thereafter T-cell immunomonitoring...