Inovio Pharmaceuticals (AMEX:INO) reported Thursday vastly encouraging phase one study results from its H5N1 Avian Flu vaccine trial.
The company said that significant T-cell and anitbody immune responses were generated during the study of VGX-3400X, Inovio's SynCon DNA vaccine for the prevention of avian flu, delivered using intramuscular electroportation.
Inovio’s SynCon vaccine design process uses a proprietary method to achieve cross-strain protection against the natural and frequent mutations of influenza strains within subtypes.
The results from the phase one study saw a strong antibody response in 96% of subjects, generated against all three strains the vaccine was designed for, as well a significant T-cell response in 72% of patients for up to seven months after first vaccination.
T-cells are a group of white blood cells, and are central to the function of the immune system.
The primary objectives of this trial were to assess safety and tolerability, while the secondary goal was the measurement of antigen-specific T cell and antibody responses. The study assessed a total of 60 healthy volunteers, 30 in the US and 30 in Korea, and the vaccine was also found to be safe and well-tolerated at all dose levels.
“We are encouraged by the immune responses generated in this proof-of-principle study of our first SynCon influenza vaccine, VGX-3400X," said president and CEO, Dr.J. Joseph Kim.
In conjunction with these results, Inovio has launched a second phase one trial as part of its universal flu vaccine program. The new study will test a multi-subtype SynCon vaccine for H1N1 and H5N1 flus, using a skin-targeted intradermal electroporator. Data from this trial is expected in the first quarter of 2012, the company said.
"The second Phase I study (INO-3510) builds on our universal influenza vaccine development program by adding a second component, targeting the H1N1 subtype and delivering vaccine formulations using our minimally invasive intradermal electroporation delivery system, which is designed to directly access the skin tissue that is most ideal for inducing preventive antibody responses," added Kim.
"Inovio’s ultimate goal is to develop a broadly cross-protective influenza vaccine simultaneously targeting multiple flu sub-types and unmatched strains within subtypes."
The company's new skin-targeted intradermal electroporation technology has been used to deliver DNA vaccines in several preclinical animal trials, and showed better results than intramuscular electroportation.
Since the first phase one study for the avian flu vaccine, Inovio started a booster study for US participants testing the vaccine with the new intradermal technology - the first ever fluy study using this method in humans. The device includes a patented design that introduces a miniaturized array, which delivers electrical pulses into the skin.Safety and immune response data is expected in the fourth quarter, the company said.