Inovio Expands HPV Immunotherapy To Aerodigestive Cancers

Inovio Pharmaceuticals announced it has expanded the clinical development of its HPV immunotherapy INO-3106 to include a Phase 1 study in aerodigestive cancers. Positive results from the trial could open the door to an orphan drug designation from the U.S. Food and Drug Administration (FDA), the company said.

The open label, compassionate use Phase 1 study will assess the immunogenicity, tolerability, and safety of INO-3106 as a monotherapy or in combination with DNA-based IL-12, the company’s proprietary immune activator. The trial will enroll patients with human papillomavirus type 6- (HPV-6) associated aerodigestive malignancies that have inadequately responded to standard treatments, such as surgery, chemotherapy, and radiation. Aerodigestive cancers affect the lips, tongue, mouth, nose, throat, vocal cords, and parts of the windpipe and esophagus.

J. Joseph Kim, President and CEO of Inovio, said, "Following our phase 2 success, we are pleased to expand our HPV franchise with this product and clinical trial targeting a different HPV type… 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.”

HPV is the most common sexually transmitted disease, affecting an estimated 11 percent of the world population at any given time. While a majority of HPV infections can be cleared by the immune system within two years, persistent infection can lead to premalignant changes in cervical cells known as the condition dysplasia. Cervical cancers result from untreated CIN2/3 infections, which affect 300,000 to 400,000 women in the U.S. each year.

The company has developed its proprietary SynCon DNA-based immunotherapies that recruit the immune system against a targeted disease. Inovio has developed several immunotherapies, including INO-3106 and VGX-3100, the latter achieving the primary efficacy endpoint in its Phase 2 trial in cervical dysplasia this July.

Inovio has also begun two other studies for another immunotherapy INO-3112 as a treatment for head and neck cancer, as well as inoperable cancer of the cervix.