BlueWillow’s proprietary adjuvant platform, originally invented at the University of Michigan, utilizes oil-in-water emulsion droplets approximately 400nm in size combined with a cationic surfactant and stabilization buffer. Antigen(s) are incorporated in either the liquid or oil phase of the droplets depending on the characteristics of the antigen(s). The platform is compatible with a wide array of antigens including recombinant protein(s) and polysaccharides while also having inherent antiviral action that enables whole inactivated virus vaccine formulation.
The size specificity of the droplets enables permeation of the nasal mucosa but prohibits crossing of the blood brain barrier leading to the platform’s strong safety profile established in both human clinical trials and numerous preclinical studies. In addition to the inherent adjuvant properties, the technology is an efficient antigen delivery system. Antigens are delivered directly to antigen-presenting-cells for uptake, processing and carriage to both regional and systemic immune system sites.
The nature of the immune response is ideal for protection against mucosal respiratory and sexually transmitted pathogens. The response is Th1 (non-inflammatory) biased over Th2 (inflammatory). T-cell and B-cell homing to the mucosa is triggered for durable cell-mediated immune memory. In addition, systemic immune responses in the form of IgG and IgA are elicited. This balanced immune response directly addresses the need for vaccines that protect against not only clinical disease but also pathogen carriage (i.e. infectivity).
BlueWillow’s adjuvant/delivery platform is the best-in-class solution for intranasal adjuvanted vaccine development. The limitations of non-adjuvanted approaches to intranasal vaccination are well-known. There now exists an adjuvant that can be used safely in humans to enable the long sought-after next generation of vaccines.
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