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GlaxoSmithKline Biologicals SA (GSK, London, UK) and Intercell (Vienna, Austria) have formed a strategic alliance to accelerate the development and commercialization of needle-free, patch-based vaccines.
GlaxoSmithKline Biologicals SA (GSK, London, UK) and Intercell (Vienna, Austria) have formed a strategic alliance to accelerate the development and commercialization of needle-free, patch-based vaccines. The agreement will include Intercell's candidate vaccine for travelers' diarrhea (TD), currently in Phase 3 trials, and an investigational single application pandemic influenza vaccine, as well as the use of the patch technology for other vaccines in GSK's portfolio.
Compared with standard immunization by needles, the patch technology could offer certain benefits, such as easy administration and direct delivery of the antigen and adjuvant to the immune system through natural defense pathway, which could make vaccination more efficient.
In studies, the patch was shown to boost cellular immunity to a diverse range of antigens and to stimulate both B-cell and T-cell responses. It contains the heat labile enterotoxin from E. coli, one of the most potent stimulators of the immune system.
Intercell's pandemic influenza patch is designed to enhance the immune response to existing injected pandemic influenza vaccines. If successful, the patch will expand the limited vaccine supplies by allowing fewer or lower doses of vaccine.
When used in a combination with an injected pandemic influenza vaccine (H5N1), the patch enhanced the immune response to the vaccine after only a single dose, resulting in a seroconversion rate of 70%, meeting the FDA and EMEA standard for approval of a pandemic Influenza vaccine. The development of a pandemic influenza vaccine patch has been funded in part by the US Department of Health and Human Services.
Under the terms of the agreement, GSK will make an upfront cash contribution of €33.6 million, in addition to an equity investment of up to €84 million through a staggered shareholding purchase option of up to 5% in Intercell. Included in the agreement are Intercell's investigational TD vaccine, currently in Phase 3, and an investigational single application pandemic influenza vaccine in Phase 2, as well as other potential future patch vaccines.