US-based Inovio Pharmaceuticals has started a Phase I/IIa clinical trial of its immunotherapy product, INO-3112, in treating human papillomavirus (HPV) associated head and neck cancer.
The Phase I/IIa trial is designed to evaluate safety, immunogenicity and clinical responses of INO-3112, which is a combination of the company’s lead active immunotherapy product, VGX-3100, and its proprietary immune activator expressing interleukin-12 (IL-12).
VGX-3100 is currently being assessed in a randomised Phase II efficacy trial for treatment of high-grade cervical dysplasia (pre-cancer).
In a Phase I trial of VGX-3100, the company showed that this immunotherapy produced high levels of durable T cell immune responses, notably CD8+ ‘killer’ T cells, in 78% of all patients in the study.
According to the company, these CD8+ T cells demonstrated the functional ability to kill target cells displaying the E6 and E7 antigens.
In preclinical animal models, the company’s HPV immunotherapy showed 100% protection against HPV E6 and E7-expressing tumours and prevented or delayed their growth.
In the open-label trial, called HPV-005, 20 adults with HPV-positive head and neck squamous cell carcinoma (HNSCC) will be treated with INO-3112 and followed for safety, immune and clinical responses.
In one part of the trial, around ten patients will be treated with INO-3112 before and after resection of their tumour, while in the second part about ten patients will be treated with INO-3112 after completion of chemotherapy and radiation therapy.
Each INO-3112 treatment will be administered using the company’s Cellectra delivery system.
Apart from evaluating safety, the trial will analyse T cell immune responses to INO-3112.
The company said that pre and post-immunotherapy tumour tissue will be analysed to assess infiltration of T cells into the tumour and tumour bed.
Clinical responses characterised by anti-tumour effects, using RECIST criteria, and progression free survival, will also be measured in the trial.
The trial will be carried out at the Abramson Cancer Center (ACC) in the Perelman School of Medicine (PSOM) at the University of Pennsylvania, by principal investigator Charu Aggarwal, assistant professor of medicine in the division of hematology-oncology at the PSOM and ACC.
Inovio president and CEO Joseph Kim said: "We will also launch additional cancer clinical studies to further characterise and expand the potential of our DNA immune therapy products and immune activators with their potent abilities to generate and activate the highest levels of antigen-specific killer T cells.
"These include trials for INO-5150 for prostate cancer with our pharmaceutical partner in Q3 and INO-1400, our immunotherapy encoded for hTERT in breast, lung and pancreatic cancer patients later this year.
"Our goal is to have the best and most extensive pipeline of active cancer immunotherapies with the potential to seek out and destroy cancer cells."