The UK-based study Phase I study - which is part funded by a grant from the Wellcome Trust – is designed to assess both SynGEM and the nasal delivery device - Teleflex VaxINator – in a real world setting according to Mucosis CEO, Tom Johnston.
Mucosis developed SynGEM using its proprietary probiotics-based technology, Mimopath. The vaccine consists of a pre-fusion version of an RSV antigen formulated for intranasal delivery.
Formulation development was a complex process according to Johnston, who said: “One of the challenges with pre-fusion F antigens has been its natural lack of stability. Mucosis was able to engineer around this to create a stable antigen and patent this design.”
The firm claims pre-fusion RSV antigens produced using the Mimopath technology stimulate production of antibodies against the virus more effectively than post-fusion versions of the same protein.
The Teleflex VaxINator Intranasal Mucosal Atomisation Device (MAD) uses pressure to aerosolize the vaccine as a ‘fine mist’ that can be delivered to the nasal passageways directly.
Studies have shown that introducing RSV antibodies via the mucous membranes generates a better systemic immune response.
In addition, the research also demonstrated that a raised antibody response in the mucous membranes helps block entry of the virus, thereby providing an effective first-line of defence.
This has prompted several other companies to pursue intranasal products – such as AstraZeneca’s nasal flu spray, Fluenz Tetra, or the Belgian biotech Ablynx’s therapy for RSV, due to start a Phase IIb efficacy study later this year.
Similarly, Ablynx’s nanobody product ALX-0171 – which is a post infection RSV antiviral therapy - has also been formulated for intranasal delivery.