A leading UK privately-owned drug-discovery group, SEEK (previously known as PepTcell) said that the company presented universal flu vaccine phase II challenge study results 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.
“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, ” said Gregory Stoloff, chief executive officer.
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 highly-mutagenic viruses. The core technology underlying this platform is a proprietary algorithm that 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 3-5 years.