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Public Funding for Avaxzipen Limited

Registration Number 10908112

Enabling the Scalable Aseptic Manufacturing and In-Vivo Testing of Novel, Solid Unit Dose, Viral Vector Vaccines for Administration by Enesi’s Needle Free ImplaVax® Delivery Technology

870,418
2019-09-01 to 2021-09-30
Collaborative R&D
Vaccines are one of the most cost-effective ways of delivering lasting benefit to human health and healthcare systems worldwide - it is estimated that they save 9 million lives each year. Today, vaccines are not only being used to prevent common childhood infectious diseases such as measles, polio, and whooping cough. Modern developments in biology have led to the creation of a range of highly targeted vaccines based on vector delivery vehicles such as vaccinia and adenovirus that can be tailored for optimum effectiveness. With such efficiency and specificity, vector-based vaccines are being developed for diseases as broad as influenza, small pox, HIV, other lethal and rare infectious diseases, allergy, biodefence, cancers, and even ultra-personalised medicines tailored to the exact needs of a patient. Most vaccines available today are delivered in a liquid/suspension form with a needle and syringe. Whilst established practice there are significant challenges innate to this presentation including needle-stick injury, cross contamination risk, sharps disposal risk, dosing error, subject pain and stress, poor thermal stability, and excessive wastage. Additionally, multiple injections are generally required to generate a lasting effect on a subjects' immune system. Ensuring an individual's compliance to a 'Prime-Boost' dosing schedule is challenging, especially when dosing is often days if not weeks apart. Enesi has developed a game changing technology that has the potential to revolutionise vaccination worldwide. Rather than delivering a vaccine in the traditional liquid form, our ImplaVax(r) technology allows the facile delivery of highly effective unit solid dose vaccine implants to the subject. Comparative pre-clinical studies using a range of classical vaccines have demonstrated that ImplaVax(r) solid dose vaccines outperform liquid equivalents with a superior and faster immune response, regimen sparing, and enhanced thermal stability. Human factor studies also indicate a strong preference (91%) for the needle-free ImplaVax(r) delivery system across all subject groups evaluated with ease and speed of administration scoring very highly. This project seeks to build on these foundations and will include the development of a robust aseptic-capable solid dose implant manufacturing processes, testing the implants on stability and conducting focused non-clinical immunogenicity studies to demonstrate the performance of the solid dose vaccine in-vivo. Success will give a high confidence that such a process can be applied to all vector-based vaccines with all associated ImplaVax(r) benefits and the potential become a mainstay of both prophylactic and therapeutic treatment in human health.

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