Inovio rallies on latest phase one results for avian flu vaccine - Proactive Investor

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Inovio rallies on latest phase one results for avian flu vaccine 0 comments

Nov 18, 2011 3:33 PM

Inovio Pharmaceuticals (AMEX:INO) said Thursday that new interim data for its avian flu vaccine, VGX-3400X, showed inhibition of multiple H5N1 strains in a phase one trial.

A single intra-dermal (ID), or through the skin, electroporation boost of the company's SynCon avian flu vaccine generated hemagglutination inhibition (HAI) titers against six different, unmatched strains of H5N1 - "a distinct new clinical achievement on the global research community’s path to develop universal influenza vaccines", it said.

HAI measurements are used to assess the generation of protective antibody responses.

Following one month, the synthetic vaccine generated a four-fold or greater rise in these titers in 50 percent of 20 boosted subjects in the phase one study. A four-fold rise in HAI titers, compared to pre-vaccination, is considered to be an important indicator of immune activation.

The results were presented at the fifth WHO Meeting on Influenza Vaccines by Inovio's senior VP of research and development, Dr. Niranjan Sardesai.

Inovio's SynCon vaccine design process is designed to provide cross-strain protection against the frequent mutations of influenza strains within subtypes.

This new interim data, based on the delivery of the vaccine using skin electroporation, follows previously reported positive data from the vaccine with intra-muscular electroporation delivery.

Indeed, in the intramuscular part of the study, VGX-3400X generated antigen-specific antibody responses against all three antigens that the vaccine was encoded to produce, the company said. High levels of binding antibodies were observed in 27 of 28 evaluated subjects, or 96 percent. The vaccine was also found to be generally safe and well tolerated at all dose levels.

In the intradermal part of the study, participants received a booster vaccination using just one component of VGX-3400X.

Inovio's new ID electroporation device uses a miniaturized needle, which creates electroporation conditions optimized for skin delivery. The goal of this study was to determine if ID delivery of the construct can increase HAI titers beyond those achieved by the initial intramuscular vaccinations.

ID vaccination was also found to be generally safe and well tolerated, the company said.
Additional interim data is expected in the first quarter of next year, following a second ID vaccination boost.

Speaking at the WHO Meeting, Dr. Sardesai commented: "These data build on the high rates of vaccine-induced antibody and T-cell responses previously elicited by our avian influenza vaccine with intramuscular delivery.

"We look forward to the next results from this single subtype synthetic vaccine as well as the first data from our multi-subtype influenza vaccine, INO-3510, which combines H1N1 with H5N1. This second influenza study exclusively uses our intradermal delivery system, which accesses the skin’s prolific immune system components that are ideal for inducing preventive antibody responses.”

Inovio's president and CEO,Dr. J. Joseph Kim, added: "Our goal is an influenza vaccine protective across subtypes and strains. While more testing is needed, these new results are an unprecedented step closer to the Holy Grail of flu vaccine research – creating a universal flu vaccine.”

The company is advancing its flu vaccine strategy with a second phase one study designed to test INO-3510, Inovio's multi-subtype SynCon vaccine to protect against both the H5N1 and H1N1 viruses, delivered through intradermal electroporation. Preliminary safety and immune response data from this 100-subject study is expected in the second quarter of 2012, Inovio said.

Inovio is also developing its SynCon vaccines for a host of diseases, including cervical dysplasia/cancer, leukemia and hepatitis C virus, as well as HIV. The company's shares were up more than 2.6 percent on Thursday, trading at $0.585 as of 11:32am ET.

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