Thursday, November 17, 2016

Inovio Pharmaceuticals, Inc. (INO) opens New Front Line in War against Cancer & Infectious Diseases with DNA Vaccines

Over 2,000 years ago, Plato, in his immortal Socratic dialogue, had the great philosopher express his astonishment at the new diseases plaguing Athenian society and their bizarre and horrible names. Our position today is very similar. Strange, horrible afflictions with bizarre, frightening names like cancer, Ebola and Zika, unknown or unrecognized until modern times, threaten us with epidemics and pandemics. For a hundred years or so, we’ve fought them off with traditional vaccines and pharmaceuticals. Now, a new battlefront is set to open with the advent of DNA vaccines from companies like Inovio Pharmaceuticals, Inc. (NASDAQ: INO).

Traditional vaccines stimulate the immune system to respond to threats from antigens in the lymph and blood. The lymph is a colorless fluid containing white blood cells that bathes the tissues. These traditional vaccines are said to stimulate humoral immunity. (Humor is a medieval term for body fluid.) The most famous of them, perhaps, and certainly the first was Edward Jenner’s smallpox vaccine in 1796. Traditional vaccines have been developed against numerous bacterial and viral pathogens, but their development against many life-threatening viruses has been elusive.

DNA vaccines, by contrast, stimulate cell-mediated immunity, which is good, since most of the scientific community believes that it is cell-mediated immunity, rather than humoral immunity, that has the dominant role in fighting viral infections. The problem is that viruses live and replicate inside cells. They seize the synthetic machinery of the host and, therefore, are sheltered from antibody surveillance. Cell-mediated immunity, however, can detect and destroy these infected cells.

Inovio Pharmaceuticals is revolutionizing the fight against cancers and other infectious diseases with a range of these DNA immunotherapies (vaccines). Its technology platform is applicable to cancers and infectious diseases and the company has developed antigen-targeting immunotherapy and vaccine product candidates for HPV-caused pre-cancers and cancers of the breast, lung, pancreas, and prostate, as well as hepatitis, HIV, influenza, and Ebola. Its lead program targets cervical dysplasia and has just completed a phase II clinical study.

In March, the company announced ( that this immunotherapy to treat cervical dysplasia (VGX-3100) had earned recognition as the “Best Therapeutic Vaccine” by the World Vaccine Congress held that month in Washington, D.C. The Vaccine Industry Excellence (ViE) Awards honor outstanding vaccine advancements and achievements of therapeutic and preventive vaccine developers across the global industry, as judged by a panel of global biotech industry stakeholders.

At present, Inovio’s proposed phase III clinical program for the VGX-3100 program is under clinical hold. The FDA has requested additional data to support the shelf life of the newly designed and manufactured disposable parts of the CELLECTRA® 5PSP immunotherapy delivery device. The hold does not pertain to any of Inovio’s other ongoing clinical studies. Management expects the VGX-3100 issue to be resolved by the first quarter of 2017, with potentially no delay in the overall completion of a phase III trial.

By year-end, Inovio expects several clinical read-outs, including those from the 40 patient Zika trial and the INO-3112 head and neck cancer study, in addition to interim data from its Middle East Respiratory Syndrome (MERS) vaccine. A research report from Aegis Capital (, issued last week, set a price target of $12.00 for Inovio’s stock, which is currently trading at just over $8.00.

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