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.”

 

For further information, please contact:


At the Company
Emergex Consilium Strategic Communications
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Chris Gardner / Ashley Tapp/ Carina Jurs

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

 

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.

Emergex Appoints Dr. Anthony Sedgwick as Non-Executive Director

Abingdon, Oxon, UK, 17 June 2021 – Emergex Vaccines Holding Limited (‘Emergex’, or ‘the Company’), a company tackling major global infectious disease threats through the development of synthetic ‘set point’ vaccines which prime the T-Cell immune response, is pleased to announce that Dr. Anthony Sedgwick has been appointed to the Company’s Board as a Non-Executive Director, effective April 2021.

Dr. Sedgwick is an experienced biotech executive, bringing over 40 years of international experience in the sector to Emergex. He was head of anti-inflammatory Biology at Roche between 1986-1990, and after a 2 year period in Marketing at Roche became Global head of Clinical operations until 2002. At Roche, Dr. Sedgwick was responsible for clinical development, leading to the launch of several products including Invirase® and Tamiflu®. He was also a member of the Company’s Global development committee, and on the Board of Roche Products Ltd UK. Dr. Sedgwick has been the Chief Executive Officer of four biotechnology companies, including Cambridge Biotechnology (2002-2005), DanioLabs (2005-2007), Novacta (2007-2011) and Silence Therapeutics (2011-2012), and has held Chairman positions at numerous companies including Plastid AS (2008-2011), ThioLogics (2011-2013) and most recently at Cotton Mouton Diagnostics (2017-2019).

Dr. Sedgwick holds a PhD in Experimental Pathology at St Bartholomew’s Hospital Medical School in London. He is a Fellow of the Royal College of Pathologists and an honorary Professor at Swansea University Medical School.

Dr. Finian Tan, Chairman of Emergex, commented: “I am delighted to welcome Anthony to our Board of Directors. He brings in an extraordinary range of experience from companies across the sector which will be invaluable to Emergex as we progress our novel vaccine candidates towards the clinic.”

Dr. Anthony Sedgwick, added: “Emergex is pioneering unique vaccine technology to address some of the world’s most challenging and immediate infectious disease threats, including COVID-19. I look forward to working with the Board at this exciting time for the Company.”

– Ends –

 

For further information, please contact:

Emergex Consilium Strategic Communications
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Robin Cohen, Director of Business Development

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

Chris Gardner / Ashley Tapp / Carina Jurs

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

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 combines validated technologies together with the very latest scientific insights in immunology and virology to develop its vaccines, including the use of synthetic peptide codes determined on actual infected cells and using a proprietary gold nanoparticle carrier system for programming.

The Company has a growing pipeline of vaccine candidates. The most advanced development programme is a vaccine for Dengue Fever, which may also be disease modifying for other Flaviviruses such as the Zika and Yellow Fever viruses. Emergex also has programmes in development for a universal Influenza vaccine and a universal Filovirus vaccine (including viruses such as Ebola and Marburg) and discovery programmes for a Yellow Fever Booster 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.