Flunisyn Phase 2a trial data shows positive results in elderly population

Apr 17 2013

Following the widely publicised US Centers for Disease Control and Prevention report in February that the current season's flu vaccine is only 9% effective in the over-65 population, Immune Targeting Systems Limited ("ITS"), today announces positive data from a Phase 2a trial with the Company's lead pan-strain influenza A T-cell vaccine, Flunisyn^TM, in the elderly population. An emerging leader in the development of T-cell vaccines against viruses and cancers, ITS also announces two major grant awards from the UK's Biomedical Catalyst funding scheme to develop chronic hepatitis B vaccine and oncology vaccine product candidates.

“FlunisynTM represents a real breakthrough - a vaccine that does not need to be re-manufactured each flu season to match circulating strains of influenza virus and because of its synthetic design the vaccine can be produced in quantities to protect the global population.”

Two previous Phase 1 dose finding and formulation assessment clinical studies in healthy adult volunteers demonstrated that Flunisyn^TM generated statistically significant cell-mediated immune (CMI) responses to the vaccine and was safe and well tolerated in vaccinated groups compared to placebo. From both trials, the T-cell responses induced by Flunisyn^TM were able to recognise multiple strains of influenza A.

This latest study in the elderly population, a group where conventional influenza vaccine is poorly effective, showed that Flunisyn^TM induced a robust CMI across a number of influenza antigens, with a responder frequency of 95%. The vaccine was found to have a good safety profile and did not negatively impact on the antibody response to conventional influenza vaccine (TIV) in subjects who received both Flunisyn^TM and TIV. These results are being presented at the World Vaccine Congress in Washington D.C. on 16^th April 2013.

Dr Campbell Bunce, ITS' R&D Director explained, "Flunisyn^TM represents a real breakthrough - a vaccine that does not need to be re-manufactured each flu season to match circulating strains of influenza virus and because of its synthetic design the vaccine can be produced in quantities to protect the global population."

Flunisyn™ vaccination stimulates the production of T-cells that recognise and destroy influenza-infected cells. In contrast, conventional influenza vaccines induce an antibody response against the virus (a "humoral" response). T-cell vaccines offer many clinical advantages over conventional vaccines, especially against rapidly mutating viruses, because they can promote immune responses to parts of the virus that do not change from one flu season to the next. Flunisyn™ is therefore applicable to multiple seasonal and pandemic influenza strains. The most conserved parts of the influenza virus are located within the internal regions of the virus particle that are not presented to the humoral arm of the immune system. This is why conventional vaccines, which only target the highly variable, external regions of the virus, have to be newly produced to counter the threat from each season's circulating strain. Conventional influenza vaccines have several additional limitations, most notably, low efficacy in at-risk populations including the elderly, chronically ill and young children; Flunisyn^TM has been designed to address these limitations.

Flunisyn™ also addresses the key demands of the US Food & Drug Administration (FDA), the European Medicines Agency (EMA), and World Health Organization (WHO): prophylactic protection against multiple strains of both seasonal and pandemic influenza, effectiveness for at-risk groups, amenability to repeated dosing, potential for combined vaccination with traditional vaccines and inexpensive, large scale manufacture and stockpiling potential for global population coverage and management of pandemic outbreaks.

In addition, the Company today announces awards from the UK's Biomedical Catalyst funding scheme. An early stage grant of £2 million has been awarded to support an 18 month development programme to take the Company's pan-genotype chronic hepatitis B vaccine, Hepsyn-B^TM, to clinical readiness. ITS has also been awarded a feasibility grant to support proof of concept work for the design of an oncology vaccine.