SEEK Announces Positive Phase I Data for Universal Flu Vaccine at World Influenza Congress

By Seek, PRNE
Tuesday, December 7, 2010

Safety and Immunogenicity in Humans Established

LONDON, December 8, 2010 - SEEK, a leading UK privately-owned drug-discovery group, today
presented data on the successful conclusion of a Phase I safety and
tolerability study for its investigational Universal Influenza Vaccine,
FLU-v, at the World Influenza Congress in Amsterdam (7-9 December).

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

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

Gregory Stoloff, Chief Executive Officer, comments: "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.[2]

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.

About the trial

The randomised trial was conducted in 48 participants, aged
between 18 and 40, and consisted of giving a single low or high dose of the
vaccine - either 250 or 500 micrograms - with or without adjuvant, or
placebo, with or without adjuvant, followed by an observation period of 21
days. The results showed that at 21 days, a single dose of adjuvanted FLU-v
induced an antigen specific T cell response (250micrograms, p=0.006,
500micrograms p=0.003) compared to placebo. FLU-v without adjuvant did not
induce a specific T cell or B cell response.

No significant difficulties or increased local pain levels
were associated with administration of FLU-v.

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.

About Influenza

Influenza 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 three and five 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.

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
product-development areas are vaccines, inflammation/autoimmune diseases,
transplantation tolerance induction, respiratory diseases, cancer and

For further information about SEEK please visit


1. Data presented at the World Influenza Congress (Europe), Amsterdam,
8th December 2010. Flu-v 001: A single centre, randomised, double blind,
Phase I study of the safety, tolerability and immunogenicity of a single S/C
dose of FLU-v, a novel universal influenza vaccine candidate.

2. Flu-v 002: A randomised double-blind, placebo controlled, Phase Ib
study in 28 volunteers to evaluate the safety, tolerability and protective
efficacy of a single subcutaneous dose of the influenza vaccine candidate
FLU-v in an influenza challenge model.

SEEK: Gregory Stoloff, Chief Executive Officer Tel: +44(0)20-7153-6570; Dr Stuart Robinson, Head of Medical Affairs Tel: +44(0)7789-487042; M: Communications: Nick Francis Tel: +44(0)20-7920-2320; Amber Bielecka Tel: +44(0)20-7920-2352

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