Inovio Pharmaceuticals Initiates Clinical Trial of INO-5150 DNA Immunotherapy for Prostate Cancer

On July 27, 2015 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that it has initiated a phase I trial to evaluate Inovio’s DNA immunotherapy in men with biochemically relapsed prostate cancer (Press release, Inovio, JUL 27, 2015, View Source [SID:1234506708]).

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The launch of this human trial follows strong pre-clinical results revealing that INO-5150 generated robust CD8+ T cell responses in animal studies including non-human primates. The immune responses generated by INO-5150 were similar in character to immune responses generated by VGX-3100, Inovio’s immunotherapy for human papillomavirus (HPV) that regressed pre-cancerous cervical lesions and eliminated HPV in a randomized, placebo-controlled phase II trial.

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INO-5150 is a novel SynCon immunotherapy for prostate cancer targeting two antigens, prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA), present in the majority of prostate cancer cells. This phase I study will evaluate the safety, tolerability, and immunogenicity of INO-5150 alone or in combination with INO-9012, Inovio’s DNA-based IL-12 immune activator. The multi-centered study will also evaluate changes in PSA levels, an important biomarker in prostate cancer.

INO-5150 was generated using Inovio’s proprietary SynCon process to enable significant production of PSA and PSMA antigens with genetic sequences differentiated from native human PSA and PSMA sequences. This patented approach is designed to help the body’s immune system overcome its "self-tolerance" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens.

Dr. J. Joseph Kim, President and CEO, said, "Inovio is focused on taking immunotherapy to the next level. Inovio is the only immunotherapy company that is generating T cells, in vivo, in high quantity that are fully functional whose killing capacity correlates with relevant clinical outcomes. With positive results from our phase II study of VGX-3100, Inovio’s active immunotherapy technology is a promising approach to treat various solid tumors by targeting the most important antigens for a particular tumor. Today’s launch of our SynCon prostate cancer immunotherapy builds on Inovio’s current trials for several difficult-to-treat cancers including head and neck, cervical, breast, lung, and pancreatic cancer."

About Prostate Cancer

Prostate cancer is the second most frequently diagnosed cancer in men. Nearly three-quarters of the registered cases occur in developed countries. Accounting for nearly 300,000 deaths each year, prostate cancer is the sixth leading cause of death from cancer in men. The development of a new treatment for prostate cancer would be a significant medical advance given that present treatment options (surgery, radiation and hormone deprivation), while somewhat effective, all carry deleterious side effects and are often not a long-term cure.