Inovio Pharmaceuticals announced the initiation of a Phase I/IIA clinical trial to investigate its immunotherapy INO-3112 as treatment for human papillomavirus (HPV)-associated head and neck cancer.
INO-3112 is a combination of the company’s lead active immunotherapy product VGX-3100 and immune activator expressing interleukin-12 (IL-12). VGX-3100 is a DNA-based immunotherapy for HPV-linked cancers as well as pre-cancers and cancers caused by HPV. The product is currently undergoing a randomized Phase II efficacy trial as treatment for high grade cervical dysplasia. INO-3112 combines the immunotherapy with a DNA-based IL-12 immune activator to further bolster the targeted immune response against head and neck cancer and other cancers.
In preclinical studies of animal models, the company’s HPV immunotherapy showed total protection against HPV E6 and E7-expressing tumors. The treatment was also able to halt or impede tumor growth. The new open-label study will be called HPV-005 and will involve up to 20 adult patients with HPV-positive head and neck squamous cell carcinoma (HNSCC). INO-3112 will be evaluated for safety, immune and clinical responses. The drug will be investigated for efficacy before and after tumor resection as well as following chemotherapy and radiation therapy in patients.
Dr. J. Joseph Kim, Inovio's CEO, said that the start of the study is only the first step in its oncology immune therapy development plans. “Onco-immunotherapy is all about T cells – the very thing which our products have been shown to stimulate extremely well. We look forward to our upcoming unblinded cervical dysplasia Phase 2 study data on efficacy and T cell responses this summer.”
Human papillomavirus (HPV) infection can lead to cervical dysplasia and cancer. HPV-linked head and neck cancer is the fastest growing cancer in men, forecasted to overtake incidence of HPV-caused cervical cancer by 2020.
The new study will be conducted at the Abramson Cancer Center (ACC) in the Perelman School of Medicine (PSOM) at the University of Pennsylvania and will be led by principal investigator Charu Aggarwal, assistant professor of medicine in the division of hematology-oncology at the PSOM and ACC.