The novel technology comprises aerosol delivery of vaccines to the lungs. Current vaccines usually involve injection with the exception of the nasally delivered FluMist®. The new route, into the lungs, which requires appropriate aerosolizer devices, has very recently been shown to be more effective, especially with respect to airborne infections and respiratory infections.
- Lower doses are effective
- Greater protection from infection
- Cross-reactive protection from related strains (potential for a genuine universal flu vaccine)
- No needles (So more acceptable, especially for important patient groups including children, the elderly, the developing world)
The ultimate utility is for vaccination against all airborne infections and respiratory infections, and indeed all infections acquired via a mucosal route and infections at mucosal sites. Over 60% of human infections are acquired via the mucosa. Furthermore the technology platform should be applicable to treating cancers occurring at mucosal sites, such as colorectal cancer and lung cancer. The WHO currently list influenza as the number one infectious disease threat, and tuberculosis as the number one infectious killer. Furthermore most exacerbations and hospitalisations of COPD, the number three killer worldwide, are due to respiratory infections (primarily RSV, rhinovirus and influenza A).
Technological validation achieved to dateThe delivery of vaccines to the lungs has been validated in pigs, ferrets and mice. The data indicate that it is much more effective than other routes of delivery. Evidence that low doses are more effective has been demonstrated both in ferrets and in mice. This delivery of vaccine is boostable and has significant benefits in terms of protection from severity of disease and death. The immune protection achieved is cross-reactive demonstrating protection against other strains of influenza. Clinical proof of concept of delivery via the lung route has been demonstrated in a WHO study with live attenuated measles vaccine. The more recent studies in pigs, ferrets and mice demonstrate that non-replication competent and inactivated virus vaccines are also effective. Similar but less effective technology has been demonstrated with live attenuated influenza virus delivered intranasally in the Flumist® vaccine. Confirmation that this route of delivery (lungs) is effective in other respiratory and airborne diseases has been demonstrated with TB in nonhuman primates.
Powell et al., 2019: https://jgv.microbiologyresearch.org/content/journal/jgv/10.1099/jgv.0.001228
Dijkman et al., 2019: https://www.nature.com/articles/s41591-018-0319-9
Maudsley et al., 2019: WO 2019/020493 A1