Compelling data from two ITS Flunisyn Phase I clinical trials against multiple strains of influenza A

Immune Targeting Systems Limited ("ITS"), an emerging leader in the development of vaccines that promote T-cell responses against viruses and cancers, today announces compelling data from two Phase I clinical trials of Flunisyn^TM, the Company's lead vaccine programme which elicits potent immune responses against multiple strains of influenza-A virus. ITS also announces the appointments of Dr. Benjamin Chen, Executive Chairman and Dr. Kevin FitzGerald, Chief Operating Officer, to support the Company as it moves towards commercialisation of its products and technologies.

The first Phase I trial showed that Flunisyn^TM generated statistically significant cell-mediated immune responses to the vaccine and was safe and well tolerated in vaccinated groups compared to placebo. The trial was a randomised, double-blind, placebo-controlled, escalating dose study in 48 healthy adult volunteers.

The second trial was a randomised, double blind study to compare the immunogenicity of Flunisyn^TM, alone or with an undisclosed adjuvant, in 48 healthy adult volunteers. Both formulations generated strong cell-mediated immunity but with the adjuvant formulation generating enhanced responses.

From both trials, the T-cell responses induced by Flunisyn^TM were able to recognise multiple strains of influenza A.

Dr. Campbell Bunce, ITS' Research Director, commented: "From these Phase I data, we are extremely encouraged to see that Flunisyn^TM induces strong, pan-strain, immune responses that have the potential to protect the population against the severe and sometimes fatal symptoms of influenza infection. Additionally, the magnitude of the immune response that was induced by Flunisyn™ is unprecedented for a peptide based approach, with or without the use of adjuvants."

Dr. Bunce continued: "ITS' T-cell vaccine platform allows the design of vaccines with the potential to provide clinical benefits that are not currently provided by other vaccine approaches. Especially important is the evidence that Flunisyn^TM induces cell-mediated immune responses across multiple influenza A strains. With the growing body of evidence for a critical role of the cellular arm of the immune system in influenza, this is a significant step forward towards the development of a pan influenza vaccine that can effectively manage seasonal and pandemic influenza infections."

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™ is therefore designed to address the key demands of main regulatory and governing bodies such as the US Food & Drug Administration (FDA), the European Medicines Agency (EMA), and World Health Organization (WHO) which include: 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.

The Company today also announces changes to the management team. Carlton Brown, co-founder of ITS, has stepped down as CEO in order to pursue other ventures and the leadership of the Company will be augmented by the appointments of Dr. Benjamin Chen and Dr. Kevin FitzGerald. Drs. Chen and FitzGerald, two biotech veterans, bring substantial experience in the commercial development of products and in the development and growth of life sciences companies.

Source: Immune Targeting Systems Limited