Translational medicine firm Oryx has completed a Phase I/IIa trial of the therapeutic vaccine VicOryx to treat p16INK4a-overexpressing Human Papilloma Virus (HPV) positive cancer patients.
The open label and single centre trial included 26 patients, who had a history of advanced HPV-positive cervical, vulvar, vaginal, penile, anal or head and neck cancers with diffuse expression of p16INK4a in the tumour after standard therapy.
ORYX CEO and founder Dr Bernard Huber said: "The VicOryx trial has shown the important potential of our therapeutic p16 vaccine.
"Inspired by the ground-breaking HPV research of Nobel Laureate Professor zur Hausen, Member of ORYX Scientific Advisory Board, and based on the VicOryx data, we are convinced that this vaccination approach can be an effective therapeutic strategy for patients with HPV-associated cancers."
The primary endpoint of the study was the induction of a cellular and/or humoral immune response against the therapeutic vaccine, after an initial interim safety assessment in 10 patients.
The trial’s secondary endpoints include safety of immunization with VicOryx and tumor response according to RECIST.
According to the company, the vaccine was safe and induced humoral and cellular immune responses and the full data from the trial will be presented at upcoming scientific conferences.
The human cyclin dependent kinase inhibitor p16INK4a is expressed as an early consequence of HPV-mediated cell transformation in HPV-associated cancers.
Humoral and cellular immune responses against p16INK4a occur spontaneously in patients with HPV-associated cancers, while in healthy people such immune responses were not observed.