Enesi Pharma Achieves Preclinical Proof-of-Concept with ImplaVax®-Enabled Pandemic Influenza Vaccine

Innovative needle-free injectable unit solid-dose presentation of recombinant H7N9 pandemic flu vaccine, created using Enesi's ImplaVax® technology, generated immune responses comparable with liquid vaccine and demonstrated excellent thermal stability at temperatures up to 40°C for six months

OXFORD, UK I May 4, 2021 I Enesi Pharma ("Enesi"), an innovative biotechnology company developing next-generation vaccination products targeting infectious diseases and emergent threat pathogens enabled by its ImplaVax® technologies, announces that it has successfully developed an ImplaVax®-enabled, solid-dose recombinant H7N9 pandemic influenza vaccine and delivered proof-of-concept results in validated preclinical models.

The project1 was conducted as part of BARDA's "Beyond the Needle" initiative, which is focused on developing alternative technologies that aim to transform the paradigm of making vaccines and therapeutics easier to administer and more widely available, without the need for needles, syringes, vials, and cold-chain distribution burdens.

During the project, Enesi successfully developed a number of unit solid-dose formulations, with and without adjuvant, of the recombinant H7N9 pandemic influenza vaccine, an important vaccine that is approved as part of the U.S. National Strategic Stockpile.

ImplaVax® unit solid-dose formulations generated highly encouraging and comparable immune responses to conventional liquid vaccine delivered intramuscularly with a needle and syringe, both in terms of antibody induction and seroconversion rates in validated animal immunogenicity models.

All ImplaVax® unit solid dose formulations demonstrated excellent thermal stability across a range of temperatures from 2° - 40°C for six months.

The positive outcome from the project will now form the basis of discussions with other U.S. agencies around the further assessment and development of Enesi's ImplaVax® platform, with further details to be announced in due course.

More details of the project and its results are being presented at the World Vaccine Congress US (4-6 May 2021, Virtual) and will be published on the Company's website after the presentation.

David Hipkiss, Enesi Pharma CEO, commented:

"We are extremely pleased with the outcome of this successful partnership with BARDA DRIVe. In demonstrating preclinical proof-of-concept with an ImplaVax®-enabled solid dose pandemic flu vaccine we have established a firm foundation for its further development that could lead to needle-free, vial-free, thermally stable, easy to deploy, unit solid-dose flu vaccine products to support key governmental health directives.

"We are grateful to the BARDA DRIVe Team for their invaluable support during this successful project, which provides further evidence of the potential benefits of solid dose vaccination as an alternative method of vaccination in future pandemic events.

"We look forward to reporting the outcomes of our multiple collaborations in which we are applying our novel ImplaVax® technology to other strategically important vaccines that aim to address significant diseases and make a positive difference to the lives of millions of people around the world."

1Initiated in April 2019, this project was funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, DRIVe, under Contract No. 75A50119C00032.

About Enesi Pharma

Enesi Pharma is developing next-generation vaccination products targeting infectious diseases and emergent threat pathogens enabled by its ImplaVax® technologies. These diseases affect millions of people around the world. We work in partnership with global companies, government agencies, leading academic institutions and non-governmental organisations with the goal of making a material and lasting positive impact on global health.

Our award-winning ImplaVax®-enabled vaccination products leverage our innovative unit solid-dose formulation and needle-free delivery technologies and are applicable across all vaccine formats. ImplaVax® products are designed to enhance the immune response and offer significant benefits for patients, care givers, healthcare professionals and payers through enhanced effectiveness, safety, ease of use, reliability and stability, and a strong subject preference over administration using needle and syringe. They can be administered with minimal training and are also rapidly deployable while eliminating the need for cold-chain storage.

Our pipeline targets a range of common and emerging infectious diseases, inflammatory diseases and allergies, and has been established through collaborations with world-class organisations, including BARDA DRIVe*, the Bill & Melinda Gates Foundation, Innovate UK, the University of Oxford, the Walter Reed Army Institute of Research (WRAIR), Sementis and the University of Adelaide.

We are also advancing a number of collaborations with leading organisations in animal health, including The Pirbright Institute and the UK's Animal and Plant Agency (APHA).

Enesi's experienced leadership team has a proven track record in the successful development and commercialisation of innovative products delivering high value outcomes for all stakeholders and is supported by a world-renowned Scientific Advisory Board.

*This project has been funded in whole or in part with US Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, DRIVe, under Contract No. 75A50119C00032.

SOURCE: Enesi Pharma

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