SEEK announces positive outcome for universal flu vaccine trial
6 Jan 2011
SEEK, a UK drug-discovery group, presented results of a Phase
I safety and tolerability study for its investigational Universal
Influenza Vaccine, FLU-v at the World Influenza Congress in Amsterdam
The results showed that the vaccine was well tolerated and had no
significant identifiable safety issues. Clear evidence of
immunogenicity (provoking an immune response) across a wide range of
the human population was also demonstrated, consistent with results
seen in pre-clinical studies.
FLU-v is the first of a new class of breakthrough T cell vaccines
that are anticipated to be effective against the highly-mutagenic
influenza virus, and has been developed to provide a single
vaccination which is effective against all strains of influenza
virus, including pandemic strains.
Gregory Stoloff, Chief Executive Officer, commented: "This Phase
I data validates our predictive model in humans, which to date had
only been validated in other species. Importantly, the data is
consistent with the immune response seen in other species — that
showed protection against many strains of flu — and we therefore
eagerly await the data from the Phase II study, which will provide
information on safety, efficacy and cross-protection against a
number of strains of flu."
A Phase II study to examine the safety, tolerability and
protective efficacy of FLU-v in an influenza challenge has also been
completed with data expected early 2011.
Using a novel predictive technique, SEEK has successfully
identified small proteins (which can be synthetically manufactured)
to which the immune system will react, in regions of the influenza
flu virus that have not changed over 60 years (in either human or
animal strains), and developed a vaccine to target them. By
targeting these reactive small proteins that are in ever-present or
"conserved" regions of the virus, the vaccine is intended to provide
long-term protection against the threat of emerging strains,
eliminating the need for an annual vaccination.
The need for FLU-v: a universal influenza vaccine
Unlike traditional vaccines, which are grown in
highly-specialised facilities, and whose production is limited by
egg supply and the process of growing a vaccine, FLU-v can be
quickly and easily manufactured in chemical plants. This allows the
vaccine to be made and administered in large quantities prior to a
pandemic outbreak, enabling a large proportion of the global
population to be protected.
Major mutations in the antigen components of the virus can result
in global pandemics, such as the outbreak of "Spanish flu" in
1918-1919, "Asian influenza" in 1957, "Hong Kong influenza" in 1968
and the H1N1 pandemic in 2010.
There is also current concern about the potential transmission of
an avian A (H5N1) strain to humans. However, even minor genetic
changes require the annual reformulation of currently-used vaccines
and re-inoculating at-risk individuals. There is therefore a
significant need for a flu vaccine that will be protective against a
range of strains of the virus and which can confer long term
immunity. FLU-v is designed to protect against both type A and B
viruses, as well as antigenic drift within each virus type.
MTB Europe published news in December 2010 of a trial of
another universal flu vaccine, called GammaFlu, taking place in
Indonesia — see: Universal flu vaccine to be tested in Indonesia