The open-label trial (HPV-004) is designed to assess safety, immunogenicity, clinical responses and disease-free survival of INO-3112 in female patients with inoperable invasive cervical cancer.
INO-3112 is a combination of the company’s lead active immunotherapy product, VGX-3100, and its immune activator expressing interleukin-12 (IL-12).
Currently, VGX-3100 is being evaluated in a randomized phase II efficacy trial to treat high grade cervical dysplasia (pre-cancer).
In this trial, patients will be given four treatments of INO-3112 every four weeks after completion of a standard chemoradiation regimen and each treatment will be a combination of 6mg of VGX-3100 and 1mg of DNA-based IL-12 delivered together intramuscularly with the CELLECTRA delivery system.
As an exploratory analysis, the trial team will assess clinical responses at the tumor site as well as evaluate disease-free survival and disease recurrence up to 12 months after the initial immunotherapy with the company’s INO-3112.
The company said that cellular (T cell) immune responses will be analyzed pre- and post-immunotherapy in the tumor tissue as well as in the bloodstream.
Inovio’s phase I trial of VGX-3100 showed that this HPV immunotherapy produced high levels of durable T cell immune responses, notably CD8+ T cells, in 78% of all patients.
The cervical cancer trial is being carried out at the University of Chicago Medical Center and the Comprehensive Cancer Center, where Yasmin Hasan, director of Gynecological Radiation Oncology and Brachytherapy, serves as the principal investigator.
Image: Inovio’s Phase I/IIa trial will evaluate INO-3112 to treat human papillomavirus (HPV)-associated cervical cancer. Photo: courtesy of Nephron