Emergex Receives Regulatory Approval for a Phase I Clinical Trial in Dengue of a T-Cell Priming Vaccine

PRESS RELEASE

Emergex Receives Regulatory Approval for a Phase I Clinical Trial in Dengue of a T-Cell Priming Vaccine

• Swiss regulatory authorities, including the Swiss Agency for Therapeutic Products (Swissmedic) have granted approval for a Phase I clinical trial of Emergex’s Dengue vaccine candidate
• The Phase I clinical trial will evaluate the safety and look for markers of T-Cell immune response in healthy volunteers
  

Abingdon, Oxon, UK, 30 June 2021 – Emergex Vaccines Holding Limited (‘Emergex’, or ‘the Company’), a company tackling major global infectious disease threats through the development of 100% synthetic ‘set point’ vaccines which prime the T-Cell immune response, announces that it has achieved regulatory approval for a Phase I clinical trial of its Dengue vaccine. The study has received approval from Swiss regulatory agencies and the first participants are expected to be enrolled soon.

The Phase I trial, named naNO-DENGUE, will evaluate Emergex’s novel T-Cell priming vaccine, which has been designed to deliver broad and long-lasting immunity by priming the body’s T-Cell response to provide rapid clearance of infected cells in the event of an infection.

This double-blind, randomised and comparator-controlled study will evaluate the safety of the investigational vaccine, PepGNP-Dengue. Evidence of a T-cell mediated immune response as a surrogate of protection against severe Dengue disease will also be evaluated.

In addition to advancing Emergex’s Dengue vaccine development, the study will provide proof-of-concept for a rapidly scalable modular peptide vaccine platform that has the potential to provide cross-reactive immunity to a range of existing or emerging viral pathogens (based on the selection and inclusion in the vaccine of conserved- viral peptides from multiple parts of the virion) – thereby reducing the chances of viral mutation impacting the efficacy of the vaccine.

Emergex uses 100% synthetic vaccines to ‘prime’ naive CD8+ T-Cells to generate virus specific CTL (CD8+ Cytotoxic T Lymphocyte cells) to kill infected cells prior to productive viral infection (host cells releasing intact virions) – thus preventing viral replication and disease in the vaccinated person. Emergex T-Cell priming vaccines have the potential for long-lasting immunity without requiring seasonal boosting, and may be better suited to rapidly mutating viruses than current vaccine technologies that rely primarily upon an antibody based immune response. Emergex vaccines have been designed to be administered via the skin using micro needles and to be stable at ambient room temperature for beyond 3 months, facilitating rapid and efficient distribution across the world and making administration of the vaccine more patient friendly.

Athan Papadopoulos, Emergex Vaccines Chief Medical Officer: “Emergex’s approach to vaccine development may offer significant potential benefits over existing approaches in terms of disease prevention and applicability to a range of serious diseases. T-Cells, as also seen lately, are one of the most important parts of the immune system. Without T-Cells, we could not survive. We are proud to be working on this programme and welcome the opportunity to gather data to support the development of this novel technology.”

Laurens Rademacher, Chief Technology Officer at Emergex, commented: “Not only is this an exciting step forward for our clinical program, the seal of approval from the world class Swiss regulatory authorities provides a validation of both our Dengue vaccine candidate and our technology platform as a whole. This marks a significant milestone in the development of our first-in-human T-Cell priming vaccines which are designed to harness the power of the body’s natural immune defences to provide broad and lasting immunity.”

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About Emergex

Emergex, a biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of synthetic ‘set point’ vaccines which prime the T-Cell immune response to address some of the world’s most immediate health threats such as COVID-19, Dengue Fever, Zika, Ebola, pandemic flu and serious intra-cellular bacterial infections.

These set-point vaccines modify the initial immune status of recipients in a way that ‘primes’ their immune systems to recognise subsequent infectious agents much like a natural infection would do, preventing an acute or severe manifestation of the disease.

Emergex uses a synthetic nano gold carrier system to deliver a specific set of peptides to the body’s immune system, generating a robust T-Cell response that has the potential to provide a rapid and broad immune response that may last for decades.

The Company has a growing pipeline of vaccine candidates. The most advanced development programmes are a vaccine for Dengue Fever. The vaccine technology offers the potential for cross-reactive immune responses for other Flaviviruses such as the Zika and Yellow Fever viruses. Emergex has programmes in development for a universal Influenza vaccine, a universal Filovirus vaccine (including viruses such as Ebola and Marburg) and discovery programmes for a Yellow Fever Booster vaccine, a therapeutic Hepatitis B vaccine and a Chikungunya vaccine.

Emergex has partnered with the Institute of Molecular and Cell Biology (IMCB) of Singapore to develop a vaccine for the emerging threat of Hand, Foot and Mouth (HFM) disease. The Company also has a collaboration in place with Brazil-based Bio-Manguinhos/Fiocruz for the development of several vaccine candidates, including a potential vaccine for COVID-19.

Find out more online at www.emergexvaccines.com.