Inovio Pharmaceuticals has initiated a Phase I/IIa clinical trial of its DNA immunotherapy product, INO-3112, to treat human papillomavirus (HPV) associated cervical cancer.
The open-label trial known as ‘HPV-004’ is designed to evaluate the 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).
At present, VGX-3100 is being evaluated in a randomised Phase II efficacy trial to treat high-grade cervical dysplasia (pre-cancer).
Those participating in the trial 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 tumour site as well as evaluate disease-free survival and disease recurrence up to 12 months after the initial immunotherapy with INO-3112.
According to the company, cellular (T cell) immune responses will be analysed pre and post-immunotherapy in the tumour tissue, as well as in the bloodstream.
The company’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 trial is being carried out at the University of Chicago Medical Center and the Comprehensive Cancer Center, where Gynecological Radiation Oncology and Brachytherapy director Yasmin Hasan serves as the principal investigator.
Inovio president and CEO Joseph Kim said: "Our goal is to fully address the post-HPV infection immune therapeutics markets, targeting not only HPV-related cervical pre-cancer but also cervical cancer as well as head and neck and anogenital cancers.
"Cancer immunotherapy is focused on generating cancer fighting T cells and freeing them to attack targeted cancer cells.
"Inovio has demonstrated that its therapies mobilise more antigen-specific T cells than any other product on the market or in development."