Inovio Pharmaceuticals Inc (INO)

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Excellent news on head and neck cancer

Inovio’s INO-3112 Shows Robust Immune Responses in Patients With Head & Neck Cancer

PLYMOUTH MEETING, Pa., Nov. 05, 2015 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today an interim data analysis showing that its INO-3112 DNA-based immunotherapy generated specific T-cell responses and was well tolerated in all evaluable patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18.

The immunology results show that INO-3112 generated robust HPV16/18 specific CD8+ T cell responses and antibodies against HPV16/18 in all 10 tested patients who received all treatments. These results will be presented today and tomorrow at the 30th Anniversary Annual Meeting of the Society for Immunotherapy of Cancer in National Harbor, MD and on Nov 20-22 at the European Society for Medical Oncology Symposium on Immuno-Oncology in Lausanne, Switzerland.

INO-3112, an active immunotherapy targeting HPV 16/18 combined with a DNA plasmid for IL-12 as an immune activator, is designed to activate patient’s immune responses to specifically kill HPV associated tumors. In this phase I/IIa study, patients with HPV positive head and neck cancer received INO-3112 once every three weeks for a total of four injections.

The characteristics of these immune response data mirror those previously observed in a phase II clinical study of VGX-3100 for HPV-associated cervical dysplasia. In that study, strong CD8+ T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints. Data from that trial was recently published in a peer-reviewed article in The Lancet. This publication details that VGX-3100 is the first therapy to demonstrate that activated killer T cells induced in the body have the power to clear neoplastic lesions as well as the virus which caused the disease.

Dr. Charu Aggarwal, MD, MPH, Assistant Professor of Medicine, Medical Oncologist at Abramson Cancer Center, University of Pennsylvania, Philadelphia and the principal investigator of this study said, “These results are in line with our hypothesis that DNA immunotherapy would lead to activation of the immune system. We are excited to follow these patients and learn about long-term results with this immunotherapy.”

Dr. J. Joseph Kim, Inovio's President and CEO, said, "These results demonstrate we’re on the right path using our DNA immunotherapies to fight cancer. In immuno-oncology, it's all about the T cells. Here we show in cancer patients that we can generate antigen-specific CD8+ killer T cell responses, which are essential to an effective immunotherapy.”

This open label study is intended to assess the safety, tolerability, and immunogenicity of INO-3112 in up to twenty five adults with HPV-positive head and neck squamous cell carcinoma. The study (NCT02163057) includes patients who are being treated with INO-3112 before and after resection of their tumor as well as patients being treated with INO-3112 after completion of chemotherapy and radiation therapy. This study currently continues patient enrollment at Abramson Cancer Center of University of Pennsylvania in Philadelphia. In August 2015, Inovio licensed INO-3112 to MedImmune, the global biologics research and development arm of AstraZeneca, for an upfront payment of $27.5 million, $700 million in potential development and commercial milestone payments, and royalties on INO-3112 product sales.

About HPV-Caused Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. Head and neck cancers associated with HPV account for nearly 3 percent of all cancers in the United States and are twice as prevalent in men as in women. Incidence rates of HPV-caused head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing. By 2025, researchers believe that HPV will be the causative factor of 90% of all head and neck cancers.