Inovio Pharmaceuticals, Inc. is focused on the discovery, development, and delivery of a new generation of vaccines, called DNA vaccines, to prevent or treat cancers and chronic infectious diseases. This next generation of immunotherapies could potentially protect millions of people from debilitation or death from diseases without adequate treatments.
Inovio moves closer to "universal" flu vacccine with new data, it says
Inovio Pharmaceuticals (AMEX:INO) said Tuesday that is moving closer to a "universal flu vaccine" as animal studies showed protective antibody immune responses against multiple H3N2 and Type B strains.
Investors cheered the news, with shares rising more than 9.3 percent to 62 cents as of late Tuesday morning.
This new data builds on previous studies by the company, which reported that its H5N1 synthetic vaccine achieved hemagglutination inhibition (HI) titers against six unmatched strains of this influenza subtype in a phase I human study.
The new flu data was highlighted by Inovio's Chief Medical Officer, Dr. Mark Bagarazzi, in a presentation and panel session at Phacilitate Vaccine Forum Washington 2012.
The H3N2, H1N1, and Type B influenza strains represented in each year’s seasonal influenza vaccine are updated annually, but only protect against a single strain within each of these subtypes.
When a selected strain mutates, the annual vaccine may not provide protection, as witnessed with the 2009 swine flu H1N1 pandemic, Inovio said.
Consequently, there is a case for a universal vaccine that is able to provide longer-term protection against all existing and potential new strains, within the flu subtypes of concern to humans.
"These new data for H3N2 and Type B in animal models further validate our strategy to develop a universal vaccine to prevent known and unknown influenza strains, as well as our entire SynCon platform," said Inovio's president and CEO, Dr. J. Joseph Kim.
Indeed, the company's SynCon technology allows it to design synthetic vaccines with the potential to protect against unmatched sub-types and strains of pathogens, including newly emergent, unknown strains of a virus that will periodically emerge through mutation, as in the case of influenza.
Inovio has created SynCon vaccine “constructs” based on influenza HA, NA, and NP proteins, from strains H1N1, H2N2, H3N2, and H5N1, which are the Type A seasonal and pandemic-potential influenza subtypes that are currently of greatest concern, as well as for the less common Type B influenza.
Unlike conventional vaccines, synthetic vaccines do not need to match a virus in order to provide protection.
"We have in animals provided protection against all of the circulating influenza strains of the last 10 years,” continued Dr. Kim.
"We expect additional H5N1 human data by the end of the first quarter and look forward to human data from our combined H5N1 + H1N1 vaccine in the second quarter of 2012.
"We expect that data from these studies, coupled with this positive data for H3N2 and Type B, will enable us to launch a clinical study of a comprehensive universal influenza vaccine in 2013."
In the study reported Tuesday for the Type A H3N2 vaccine, investigators immunized mice and guinea pigs with the synthetic vaccine designed to produce the influenza hemagglutinin (HA) antigen in the animals.
To date, blood samples from the animals have been tested for immune responses against unmatched strains from several clades of H3N2.
Like the branches of a tree, there are dozens of distinct strains within each of these clades.
The animals immunized with the SynCon H3N2 vaccine developed antibody responses exceeding the level commonly associated with protective immunity against several clades of H3N2 tested, which included strains circulating in the 2000-01, 2006-07, and 2008-09 flu seasons.
Additional animal testing of the remaining few H3N2 clades will continue in 2012, Inovio said, and will include a new strain, H3N2v, which was selected this month by the Center for Disease Control as a pandemic vaccine target.
The company said results of the H3N2 vaccine study were similar to the animal trial of Inovio’s SynCon Type B vaccine, where investigators tested blood samples from immunized mice for immune responses against multiple, unmatched strains of Type B influenza.
Type B influenza mutates more slowly than Type A, but enough to preclude lasting immunity, Inovio said.
The company's SynCon vaccine platform is used with its electroporation delivery technology. Aside from the flu, Inovio also has clinical programs for cervical dysplasia, leukemia, the hepatitis C virus, and HIV.