Inovio Pharmaceuticals, has initiated a phase I clinical trial in patients with aerodigestive cancers. The trial will evaluate the safety, tolerability, and immunogenicity of INO-3106. This immunotherapy targets human papillomavirus type 6 (HPV-6), which causes most aerodigestive cancers.

Aerodigestive cancers affect the lips, mouth, tongue, nose, throat, vocal cords, and parts of the esophagus and windpipe. The unmet need for patients suffering from this form of cancer is significant.

This study is part of Inovio's strategy to broadly expand clinical development of its DNA-based immune therapy products to treat different HPV types and the many diseases they cause. It is a phase I, open label compassionate study enrolling patients with invasive cancer who have exhausted all other treatment options (chemotherapy, radiation and surgery). The study will test Inovio's immunotherapy, INO-3106, alone or in combination with DNA-based IL-12, Inovio's proprietary immune activator, in subjects with HPV-6 associated aerodigestive malignancies. Successful results could open a path to pursuing an FDA orphan designation (special status granted for therapies for rare diseases) for aerodigestive cancers.

Earlier this year, Inovio reported positive top-line phase II efficacy data for VGX-3100, its SynCon immunotherapy targeting pre-cancers and cancers caused by HPV-16 and HPV-18. VGX-3100 showed the ability to eliminate HPV infection and cause full regression of high grade cervical dysplasia (CIN 2/3). Inovio is advancing VGX-3100 into a phase III registration study with target patient characteristics and a treatment regimen similar to the phase II study. In addition, Inovio has initiated two separate studies testing INO-3112 to treat head and neck cancer as well as inoperable cervical cancer.

Dr. J. Joseph Kim, president and chief executive officer, said, "Following our phase II success, we are pleased to expand our HPV franchise with this product and clinical trial targeting a different HPV type. Our SynCon immunotherapies have been shown to activate the immune system to bring about desired efficacy with a very favorable safety profile. This makes them well-suited to potentially treat the broad spectrum of HPV-associated cancers and pre-cancers as well as HPV itself, which is one of the most prevalent cancer-causing viruses."