Inovio Pharmaceuticals (AMEX:INO) said Tuesday that the first patients have been treated in its clinical study testing immune responses in elderly adults that were immunized with the company's H1N1 universal flu vaccine.
The phase 1 study
will look at the ability of Inovio's SynCon vaccine alone, as well as
in combination with the 2012 seasonal influenza vaccine, to generate
protective levels of immune responses.
The company will also
look at the vaccine's ability to generate specific antibody immune
responses against unmatched flu strains, and T-cell immune responses
that can be helpful in fighting the flu, especially for the elderly,
which are absent from current flu vaccines.
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.
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.
noted that the population most susceptible to the flu, those over 65
years of age, represent about 90 per cent of annual flu deaths in the US
as older people's immune systems are typically weaker.
phase 1 open label study will take place at the University of Manitoba
in Winnipeg, Canada, funded in part by a grant from the Canadian
Institute of Health Research, Inovio said.
In the trial, 50 healthy elderly patients will be divided into three groups.
group of 20 subjects will receive a 2 dose regimen of Inovio's H1N1
SynCon flu vaccine delivered using the company's own intradermal
electroporation device, while a second group of 20 will receive one dose
of Inovio's vaccine delivered using electroporation followed by a dose
of the 2012 trivalent seasonal flu vaccine 24 weeks later.
third group of 10 subjects will receive a placebo delivered by
electroporation followed by a dose of the seasonal flu vaccine 24 weeks
The study will assess the tolerability, safety, and the immune responses of the different vaccination regimens.
recently reported protective levels of immune responses against six
unmatched strains of influenza in our H5N1 clinical study and expect
data in the third quarter from our second influenza study, which
includes an H1N1 component and is being tested in a population less
vulnerable to influenza," said president and CEO, Dr. J. Joseph Kim.
achieved best-in-class T-cell responses against other diseases, we will
also assess T-cell generation against influenza, which is widely
believed to be an important avenue to increasing protection for the
highly at-risk 65-plus population."
In January, the company
reported it was moving closer to a "universal flu vaccine" as animal
studies showed protective antibody immune responses against multiple
H3N2 and Type B strains.
The data built 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.
vulnerability of elderly in mind, Inovio said the new clinical study
will aim to assess the ability to generally induce stronger antibody
responses, as well as provide universal cross-strain protection and
stimulate a part of the immune system not triggered by conventional flu
"There have been limited new vaccine innovations with
the potential to better protect the elderly against influenza," said
chief of the Special Pathogens Program at the Public Health Agency of
Canada, and a principal investigator of his study, Dr. Gary P. Kobinger.
"We are pleased to conduct this trial to evaluate this potential breakthrough influenza vaccine technology."