HPV Therapy INO-3106 Demonstrates Clinical Efficacy against Rare Respiratory Tract Tumors

Inovio announced its novel therapy INO-3106 against the human papilloma virus type 6 (HPV 6) demonstrated clinical efficacy in a study of two patients with recurrent respiratory papillomatosis (RRP). RRP is an HPV-associated disease that can cause noncancerous tumor growths leading to life-threatening airway obstructions, and occasionally progresses to cancer. RRP is primarily caused by two strains of HPV, HPV 6 and 11, which also predominantly cause genital warts. RRP may occur in adults (adult-onset RRP) as well as in children (juvenile-onset RRP) who are thought to have contracted the virus during childbirth. Currently, the disease is incurable and can only be treated by surgery to remove the tumors, which temporarily restores the airway. The tumor always recurs and the surgery must be repeated, usually multiple times a year.

Inovio's pilot clinical study enrolled two adult patients with RRP and one adult patient with tracheal cancer, all positive for HPV 6. One patient with tracheal cancer discontinued the study prior to the completion of follow-up. In the two patients with RRP, their condition had required surgery approximately every six months to clear the tumor growths. Following their last dose of Inovio's HPV therapy, both patients have been surgery-free, due to lack of tumor recurrence. One patient has not needed surgery for over two years; the other has been surgery-free for over one year. A complete study report is being prepared as a medical publication. Inovio plans to further develop INO-3106 as a novel non-invasive immunotherapy for the treatment of RRP, a rare, orphan disease, for both adult and pediatric populations.

This data was presented at this week's Annual Meeting of American Association for Cancer Research by David B. Weiner, Ph.D., Executive Vice President and Director of the Vaccine & Immunotherapy Center at the Wistar Institute and Inovio's co-founder.

"This exciting new data adds to the growing body of evidence that Inovio's immunotherapies drive clinical efficacy in multiple HPV-related diseases. We've already demonstrated clinical efficacy of our therapies in three separate clinical indications: in cervical precancers with VGX-3100, in head and neck cancer with MEDI0457 with our partner AstraZeneca, and now in a challenging respiratory tumor with INO-3106. Our goal is to become the "go-to" immunotherapy provider to effectively treat all major HPV-related precancers and cancers, and I believe we are on our way there. With this RRP clinical data, Inovio plans to rapidly advance this product as a non-surgical treatment for this rare orphan disease," Dr. J. Joseph Kim, Inovio's President and CEO, said.

Inovio's most advanced HPV therapy VGX-3100 in Phase 3 targets HPV types 16 and 18, which accounts for most HPV-associated cancers. However, most RRP are caused by HPV types 6 and 11. Inovio is developing INO-3106 as a separate product through its own regulatory pathway as part of the company's overall HPV franchise. For this pilot study, Inovio designed INO-3106 encoding HPV 6 antigens alone or in combination with INO-9012, an IL-12 molecular adjuvant. Each patient received four doses administered by Inovio's CELLECTRA® delivery technology.

Recurrent respiratory papillomatosis (RRP) is a rare disease (estimated at 20,000 active cases in the U.S.) that is characterized by the growth of tumors in the respiratory tract caused by the human papilloma virus. Although benign, papillomas can cause severe, even life-threatening airway obstruction and respiratory complications. A distinguishing aspect of this disease is the tendency for the papilloma to recur after surgical procedures to remove them. Left untreated, if RRP develops in the lungs, affected individuals can potentially experience recurrent pneumonia, chronic lung disease (bronchiectasis) and, ultimately, progressive pulmonary failure. In extremely rare cases (i.e. less than 1% of cases), papillomas can become cancerous (malignant transformation) developing into squamous cell carcinoma. Additional symptoms of RRP can include hoarse voice, difficulty in sleeping and swallowing, and chronic coughing. RRP symptoms are more severe in children than in adults. In children, the disorder is most often diagnosed between the ages of 2-4. In adults, the disorder occurs most often in the third or fourth decade.

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