7 November 2011
SEEK announces successful Phase II challenge study of its
Universal Influenza Vaccine, FLU-v
Single vaccination effective against all influenza strains
Data to be presented at Influenza Congress 2011 USA
SEEK, a leading UK privately-owned drug-discovery group, today announced encouraging results
following the successful completion of its Universal Flu Vaccine Phase II challenge study. The full
data will be presented today at the Influenza Congress 2011 in Arlington, Virginia, USA.
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. It has been developed to provide a single vaccination
which is effective against all strains of influenza virus, including pandemic strains.
The trial was a challenge study whereby healthy volunteers are exposed to an attenuated (mild)
strain of flu. Vaccinated subjects showed significantly lower symptom scores and viral titre levels
compared with non-vaccinated subjects. In addition and most critically, blood cells from vaccinated
subjects showed a cross-reactive immunity to a range of influenza viruses including both animal and
human A and B strains. This demonstrates a significant breadth of response and thus the potential
for a universal vaccine able to protect people against both annual flu and pandemic strains. Flu-v
was well tolerated.
Gregory Stoloff, Chief Executive Officer, commented: “These data, coming so soon after the
excellent Phase Ib/II HIV trial results obtained using the same technology platform, validates SEEK’s
approach and methodology used in selecting its vaccine components, and demonstrates that
effective and well tolerated vaccines can be produced against highly-mutating viruses.”
SEEK’s unique vaccines technology overcomes the normal evasion mechanism that viruses employ to
stop the immune system from generating sufficient memory to conserved regions of the virus
proteins, a major stumbling block of vaccine development to date. The Company is able to identify
those conserved regions (non-mutating parts) of highly-mutating viruses that are most likely to be
binding and reactive and hence generate immune responses. It then creates vaccines by combining
synthetically-produced polypeptides comprising the identified conserved regions.
SEEK’s scientific approach is based upon a new insight into how the human immune system
differentiates, at molecular-level, between “self” and “non-self” (“Immune Activation”). The Immune
Activation theory was applied to the development of a vaccine-technology platform targeting highlymutagenic viruses. The core technology underlying this platform is a proprietary algorithm that
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predicts the propensity of parts of proteins to bind to molecules on cells and react with immune
cells, enabling SEEK to identify those conserved regions.
SEEK’s Universal Flu vaccine could be available for use, subject to regulatory approval, in the next 35 years.
About the Trial
The randomised double-blind trial was conducted by Retroscreen Virology Limited in 28 male
volunteers, aged between 18 and 40 years, receiving a single vaccine of 500 micrograms in adjuvant
or no vaccination, followed 21 days later by a challenge with an H3N2 A Wisconsin influenza virus.
The development of symptoms and viral infection was then observed for the following 8 days.
Professor John Oxford Scientific Director of Retroscreen Virology Ltd., and Professor of Virology at
St Bartholomew’s and the Royal London Hospital, Queen Mary’s School of Medicine and Dentistry
commented: “As far as I am aware, this vaccine is the only late-stage vaccine development
candidate that is synthetically manufactured and not DNA-based or requiring vector delivery. This
vaccine clearly has a biological effect worthy of further investigation, particularly with respect to the
broadness of the response.”
About Flu
Flu is a common human disease that spreads around the world in seasonal epidemics and affects 5
to 15% of the population annually. These epidemics are thought to result in between 3 and 5 million
cases of severe illness and between 250,000 and 500,000 deaths every year. The current viruses
causing this disease are divided into two groups, A and B, and these can be further subdivided by
their surface antigen components.
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-inoculation of 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. SEEK’s vaccine is designed to protect against
both type A and B viruses, as well as antigenic drift within each virus type.
- ENDS For more information about SEEK please contact:
SEEK
Gregory Stoloff, Chief Executive Officer - Tel +44 (0)20 7153 6570
M:Communications
Mary Clark / Amber Bielecka / Hollie Vile - Tel +44 (0)20 7920 2330
seek@mcomgroup.com
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Influenza Congress, USA 2011
Dr. Wilson Caparros-Wanderley, Chief Scientific Officer of SEEK will present further data on the
Phase II trial at the Influenza Congress, USA 2011, November 8-10 in Arlington, Virginia.
About Seek
Founded in 2004, SEEK - previously known as PepTcell - is privately-owned and funded, with
headquarters in London, UK. Using a pioneering scientific and commercially-driven approach, SEEK
aims to create breakthrough medicines which address major diseases in order to radically improve
human health. SEEK’s strategy is to take promising molecules through the challenging stages of
discovery to late-stage human proof-of-principle and then to seek partners to take the molecules
through the final stages of development and ultimately commercialisation. SEEK’s current productdevelopment areas are vaccines, inflammation/autoimmune diseases, transplantation tolerance
induction, respiratory diseases, cancer and diabetes/obesity.
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