French biopharmaceutical firm Vaxon Biotech has reported positive findings from the Phase IIb clinical trial of Vx-001 for the treatment of patients with non-small-cell lung cancer (NSCLC).
Vx-001 is a therapeutic cancer vaccine based on antigens called optimised cryptic tumour peptides.
The results demonstrated that the patient survival more than doubled in case of a subgroup, which included subjects who never smoked or were light smokers with non-immunogenic tumours.
Initiated in August 2011 at 70 European sites, the double-blind, placebo-controlled Phase IIb trial assessed Vx-001 in 190 metastatic and distant recurrent NSCLC patients, who demonstrated disease control following treatment with platinum-based first-line chemotherapy.
The trial assessed overall survival as the primary endpoint, while the secondary endpoints included time-to-treatment failure and 12-months overall survival rates.
Vaxon Biotech CEO and founder Dr Kostas Kosmatopoulos said: “Preliminary results of this study suggest that Vx-001 can render sensitive tumours that are initially resistant to immune checkpoint inhibitors.
“It could also mean a potential for wider application in cancers where current immune checkpoint inhibitors are ineffective.”
The findings also showed that Vx-001 can turn cold tumours hot for using the natural immune system in response to select tumour sub-types.
Vaxon is planning to perform a confirmatory study to further assess the promising subgroup from the Phase IIb trial.
The study will include NSCLC patients who are HLA-A2 positive, negative for EGFR and ALK mutations, non-smokers or light-smokers without natural immunity in stage IV, following four cycles of platinum-based chemotherapy.
The target population is expected to represent approximately 22,000 new patients each year.