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

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 – 4 May 2021 – 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.