US-based Inovio Pharmaceuticals has started the Phase I clinical trial of its immunotherapy INO-3106 to treat patients with aerodigestive cancers.
The trial is designed to evaluate the safety, tolerability and immunogenicity of INO-3106, which targets human papillomavirus type 6 (HPV-6) that causes most aerodigestive cancers.
Lips, mouth, tongue, nose, throat, vocal cords and parts of the esophagus and windpipe are affected by these tumours.
The trial is part of the company's strategy to expand clinical development of its DNA-based immune therapy products to treat different HPV types and the many diseases they cause.
Patients with invasive cancer who have exhausted all other treatment options, such as chemotherapy, radiation and surgery are being enrolled in this trial.
The trial will assess INO-3106, alone or in combination with DNA-based IL-12, the company's proprietary immune activator, in subjects with HPV-6 associated aerodigestive malignancies.
According to the company, successful results could open a path to pursuing an FDA orphan designation for aerodigestive cancers.
The company previously 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.
In that trial, VGX-3100 showed the ability to remove HPV infection and cause full regression of high grade cervical dysplasia (CIN 2/3).
The company is advancing VGX-3100 into a Phase III registration study with target patient characteristics and a treatment regimen similar to the Phase II trial.
Additionally, the company has started two separate trial evaluating INO-3112 to treat head and neck cancer as well as inoperable cervical cancer.
Inovio president and CEO Joseph Kim 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 favourable 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."