Emergex Receives Patent Protection for First-in-Class Influenza A Vaccines with Potential to Provide Long-Lasting T-Cell Immunity

• Breakthrough patent represents a significant step forward in influenza pandemic preparedness and validates the company’s innovative approach to developing influenza vaccines using viral peptides derived from a negative-sense strand of the viral genome

ABINGDON, United Kingdom, Aug. 22, 2024 (GLOBE NEWSWIRE) — Emergex Vaccines Holding Limited (“Emergex” or the “Company”), a clinical-stage biotechnology company targeting major global infectious diseases through the development of synthetic T-cell-primed vaccine candidates, today announced that Emergex has received patent protection from the United States Patent and Trademark Office (USPTO) for its novel class of influenza vaccines that have the potential to provide long-lasting T-cell immunity against all legacy strains of influenza A since 1918, as well as seasonal variants and heterosubtypic changes. This groundbreaking patent covers Emergex’s vaccine, which in part comprises immunogenic peptides encoded by a negative sense open reading frame (ORF) from segment 8 of the influenza A genome. To Emergex’s knowledge, this is the first known patent for viral peptides derived from antigenomic translation, suggesting that segment 8 of influenza A is ambisense (negative and positive sense ORFs).¹ In addition, this gives the company exclusive rights to develop a vaccine that contains these immune elements, which provides a level of immune recognition that existing flu vaccines cannot provide, due to their composition or method of administration. This also further expands Emergex’s impressive portfolio of approximately 100 technological inventions across multiple technologies and jurisdictions.

A large ORF in the negative sense strand of segment 8 in human influenza virus A (NEG8) has been conserved for over 100 years.² The length of the NEG8 ORF is represented by three eras, and each era change (i.e., pandemic index strain) corresponded to the onset of a global H1N1 pandemic. Although previously not thought to be translatable, Emergex successfully identified a number of peptides presented by MHC class I molecules on influenza-infected cells that are encoded by NEG8. Cluster stacks of these NEG8-derived epitopes, as determined by immunoproteomics, are conserved across influenza A serotypes (era-related) and are potential key targets for inducing heterologous CD8 T cell immunity and are therefore optimal for inclusion in vaccines in pandemic preparedness. Furthermore, the inclusion of avian and equine species-specific NEG8-derived peptides in a vaccine also has the potential to extend protection against zoonotic transmissions.

Professor Thomas Rademacher, co-founder and CEO of Emergex,comment given: “Our research into NEG8 has revealed exciting potential for a new approach to influenza vaccines. We believe that a vaccine formulation containing conserved NEG8-derived MHC class I peptides can provide protection against past, existing, and emerging human influenza viruses, and prevent zoonotic influenza viruses from establishing themselves in the human population and causing a pandemic. Emergex aims to use this NEG8 epitope-containing vaccine to generate a durable and broadly protective cellular immune response upon vaccination.”

Emergex plans to advance its first-in-class influenza vaccine to clinical trials, with Phase I trials expected to begin in the first half of 2025.

About Emergex

Emergex is a privately held, clinical-stage biotechnology company headquartered in Abingdon, Oxon, UK with an operating subsidiary in Doylestown, Pennsylvania, a microneedle manufacturing facility in Fremont, CA, USA and a GMP manufacturing vaccine facility in Milton Park, UK. The Company is a pioneer in the development of 100% synthetic T-cell primed vaccine candidates designed to mimic the body’s natural T-cell immune response to destroy and clear pathogen-infected cells, protecting against some of the world’s most pressing health threats. The candidates are also specifically designed for delivery using novel microneedles via skin immunization in the epidermal layer, intended to reduce the burden and logistics associated with conventional preventive measures. The first indications that Emergex is pursuing are against infectious diseases: (i) viral infectious diseases, including betacoronaviruses, dengue fever and pandemic influenza candidates, as well as (ii) intracellular bacterial infectious diseases, such as tularemia caused by Francisella tularensisEmergex has a growing, proprietary pipeline of innovative candidates with the potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

More information can be found online at www.emergexvaccines.com.

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¹ Strauss JH, Strauss EG. Overview of viruses and virus infection. Viruses and human disease. 2008:1–33.
² Clifford M, Twigg J, Upton C. Evidence for a novel gene associated with human influenza A viruses. Virol J. 2009;6:198.