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Inovio shares up over 4% on positive results from second HIV trial

Inovio Pharmaceuticals (AMEX:INO) announced Wednesday it achieved a best-in-class clinical immune response under its Pennvax line of vaccines to protect against the HIV virus, from its phase 1 clinical trial, HVTN-080.

Inovio's stock rose 4.23% to $0.74 per share in morning trading.

The aim of the phase 1 clinical trial was to test the safety and efficacy of the Pennvax-B vaccine, designed to protect against the strains of HIV that are most prevalent in North America and Europe.

The randomized, double-blind, multicentre study enrolled 48 healthy, HIV-negative volunteers to examine the immune response generated by Inovio's Pennvax-B vaccine. The vaccine was administered using the company's electroporation technology, which enhances immune responses to DNA-based immunogens.

Of the 48 subjects, eight patients received a placebo, ten patients received a three milligram (mg) dose of the Pennvax-B vaccine, while the remaining 30 subjects received a 3 mg dose of the Pennvax-B vaccine, and a 1 mg dose of Genevax IL-12, an adjuvant HIV vaccine developed by Profectus BioSciences Inc, which enhances the effect of Inovio's Pennvax-B.

Patients were vaccinated at months zero, one, and three, and were evaluated following the administration of the third vaccination.

Of the 36 evaluated patients, 83.3% showed a response to at least one of the CD4+ or CD8+ T-cells, two types of antigens that stimulate the immune system. Of the 27 evaluated patients who received the adjuvant IL-12 drug, 88.9% displayed an immune response to one or both of the T-cells.

Inovio said the investigators of its study, which was sponsored by the National Institute of Allergy and Infectious Diseases, concluded that the Pennvax-B vaccine in combination with the IL-12 adjuvant led to more and stronger cellular immune responses compared to those reported from current vector-based HIV vaccines.

Principal investigator of the study, Dr. Spyros Kalams said: "These data show for the first time that HIV-specific immune responses may be enhanced with DNA and a plasmid cytokine adjuvant (IL-12) delivered via electroporation.
"The results of this study represent a significant advance for the ability of a DNA based vaccine to generate high levels of immune responses against HIV antigens and is transformative for DNA vaccination."

After the three vaccinations, administered with IL-12, 80.8% of patients generated CD4+ T-cell responses, while 51.9% developed an immune response to the CD8+ T-cell. Six months after the final dose, 53.6% of patients maintained a positive CD4+ T-cell response, while 42.9% of patients maintained a positive CD8+ T-cell response.

Inovio president and CEO, Dr. J. Joseph Kim added: "These data are consistent with the previously announced interim results and unequivocally demonstrate the impact electroporation has on improving the immune potency of DNA vaccination."

The results of this study, and Inovio's Pennvax-G study, which was announced on Tuesday, were presented at the AIDS Vaccine Conference in Bangkok, Thailand.