Vaccine oral12 Aug 2020 08:49
Strategic Update - Potential Oral Applications
The more work undertaken and data that has been collected on Nuvec®, the more the Directors have gained an understanding of the potential applications for Nuvec® which could give it a competitive advantage over existing delivery systems that are currently in use. To date, the majority of work to explore Nuvec®'s potential has been centred on administering it by injection, in keeping with the vast majority of vaccines (both existing and in development) which use a parenteral administration of a dosage through injection; be it intravenous, subcutaneous or intramuscular. However, recent research on Nuvec® indicates that its unique spiky structure could give it a significant competitive advantage as a potential delivery system for use in oral vaccines.
Oral vaccine delivery offers a number of potentially significant advantages over other routes of administration, such as:
· oral vaccines are cheaper to administer, since they can be delivered outside of a formal clinical setting without the need for trained personnel;
· the elimination of needles from the vaccination process can minimize patient and caregiver trauma;
· it negates concerns regarding the reuse and disposal of needles, which has been shown to be responsible for a number of vaccination-related infections;
· oral vaccines may also be cheaper to produce, due to less stringent regulatory requirements for preparations that are administered orally compared with parenterally e.g. the reduced need for sterile manufacture; and
· as an enteric capsule lyophilised final product, storage conditions are less onerous than injectable products.
Notwithstanding all these potential commercial benefits, taken together, these advantages could make an oral vaccine particularly valuable to less developed countries where vaccinations can be particularly important in the protection of life of the most vulnerable.
Despite these potential advantages, there are a number of issues that need to be addressed to establish an orally delivered vaccine, and existing delivery systems used in the parenteral space are not well placed for this. In each case the data the Company has accumulated suggests that Nuvec® could be a viable solution to address these issues.
1. For effective oral immunisation, vaccine antigens (protein or DNA/RNA) must be protected from the acidic environment of the stomach and also protected from the proteolytic milieu of both the stomach and intestine. Lipid nanoparticles ("LNP") are not suited to lyophilisation but rather must be retained as a liquid or semi-solid formulation.
Protection from the stomach acid and pepsin proteolysis can be achieved readily by delivering the product in acid resistant tablets or capsules. This is a well-established principle in pharmaceutical development and would be readily applicable to Nuvec® which has been shown to be suitable for lyophilisation. The monodisperse nanoparti
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