Emergex Generates Chikungunya Ligandome, a Milestone in the Development of its T cell Adaptive Vaccine

  • Peptides specific to Chikungunya (CHIKV) virus expressed on surfaces of infected cells (collectively termed the viral “ligandome”) experimentally identified
  • The peptides are derived from CHIKV viral proteins that are highly conserved across the Togaviridae viral family
  • This demonstrates Emergex’s ability to respond rapidly to infectious disease threats using its highly adaptable plug-and-play technology

Abingdon, Oxon, UK, 28 November 2022 – Emergex Vaccines Holding Limited (‘Emergex’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, announces today that it has generated a Chikungunya (CHIKV) ligandome, the first major milestone in the development of Emergex’s CD8+ T cell CHIKV Adaptive Vaccine candidate.

Using an immunoproteomics approach, naturally presented MHC Class I-restricted peptides on the surface of a human leukocyte antigen (HLA)-typed cell line infected with CHIKV virus were extracted and identified. Over 120 viral peptides were identified exclusively from infected cells, 65 of which were common to two fragmentation techniques used for peptide analysis. Peptides (6 to 15 amino acids in length) were mainly derived from structural proteins (>90%) and included those with binding motifs indicating binding of several HLA alleles with a preponderance of predicted affinity to HLA-C. The viral peptides presented by MHC Class I molecules on the surface of infected cells can be recognized by CD8+ T cells that are able to destroy virally-infected cells. In addition to viral peptides, self-derived peptides/proteins were also identified in the ligandome. CHIKV infection was found to increase the diversity of self-peptides in the host cell by 4.9-fold and expression of self-proteins by 2.7-fold, indicating that viral infection may modulate cellular processes. Whole cell proteome analysis provides additional important information about cellular microenvironment changes upon viral infection, which includes potential alterations in the immunoproteasome and metabolism pathways.

The library of CHIKV ligandome peptides identified by Emergex will now enter the next phase of development. Candidate peptides will be selected, the vaccine construct generated at Emergex’s in-house manufacturing facility near Oxford, and preclinical studies will be conducted in the laboratories at Emergex USA. Inclusion of the ligandome into the vaccine construct will require the selection of eight to twelve peptides from amongst the CHIKV peptide set (ligandome), all of which meet a number of specific criteria. In vitro efficacy studies will then need to be completed.

Laurens Rademacher, Chief Technology Officer at Emergex commented: “The ligandome identified allows the addition of a Chikungunya vaccine candidate to Emergex’s pipeline. This is beneficial in both diversifying Emergex’s product portfolio and providing a potential global solution to Chikungunya virus-related disease burden. The candidate will be advanced through our normal development pathway with Phase 1 human trials anticipated in Q1 2024. We would like to thank DHSC and Innovate UK Research and Innovation (IUK) for its support in this project.”

Dr. Xiaofang Huang, Head of Immunoproteomics at Emergex USA commented: “To date only computer algorithm predictions or data from screening of virus construct infected cells have been used to infer the identity of the T cell epitopes on Chikungunya (CHIKV) virus. Neither approach can definitively conclude that a CD8+ T cell response against CHIKV infection has occurred. The ligandome library which contains viral and self MHC class I peptides has been established successfully by using the Emergex proprietary vaccine development platform, which provides a rational basis for CD8+ T cell vaccine development. We believe this is a significant step towards an effective CHIKV vaccine and look forward to progressing our programme in the coming months.”

This research was funded by the Department of Health and Social Care (DHSC) and delivered by IUK. DHSC is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer. This investment is part of the UK Vaccine Network (UKVN). UKVN was established to provide funding to support the development of promising vaccines and vaccine technologies that will help combat infectious diseases that have epidemic potential in low and middle-income countries (LMICs). UKVN is a £190m UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs).

Dr Phil Packer from UK Research and Innovation (UKRI) added: “Innovate UK has continually recognised the importance of investing in, and delivering innovative solutions to address the threat of infectious disease on global health and security. The initial findings of this Emergex project are highly encouraging and demonstrate that the UK continues to be at the cutting edge of vaccine research. IUK looks forward to seeing this product progress into the clinic.”

The CHIKV virus is an RNA virus belonging to the viral family Togaviridae, and is spread to humans by the bite of infected mosquitos, with the potential for mother-to-child transmission. The disease, first identified in Tanzania in 1952, has spread rapidly over the past two decades and has since been reported in over 60 endemic countries throughout Africa, Asia, Europe, and the Americas.1 Globalisation of the disease, including its import into Europe, can be attributed in large part to viraemic travellers, resulting in a number of localised outbreaks. The number of cases continues to rise, especially in temperate regions, with infection identified in nearly 40 countries2 and imparting a high public health burden with more than two billion people currently at-risk for contracting the virus.3 There is no vaccine on the market to prevent CHIKV infection, nor medicine to treat existing cases.

References

https://www.who.int/news-room/fact-sheets/detail/chikungunya

https://www.paho.org/en/topics/chikungunya

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7100975/

– Ends –

 

For further information, please contact: 

 

Emergex   Consilium Strategic Communications  
Storme Moore-Thornicroft, Executive Director 

Phone: +44 (0) 1235 527589 

Email: smt@emergexvaccines.com 

  

Chris Gardner / Ashley Tapp  

Phone: +44 (0)20 3709 5700 

Email: Emergex@consilium-comms.com 

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells in order to provide protection against some of the world’s most urgent health threats: [i] viral infectious diseases, amongst which are Universal Coronavirus, Dengue Fever and Universal Influenza A, including pandemic influenza, as well as [ii] intra-cellular bacterial infectious disease.

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue Fever (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and [ii] Universal Coronavirus. Other programmes in development include vaccine candidates for Universal (pandemic) Influenza, Chikungunya, Hand, Foot, and Mouth Disease, Zika, and a booster vaccine for Yellow Fever. The programmes in the Discovery phase, for which our proprietary ligandome has been developed, include Francisella tularensis (intra-cellular bacterium), and a smallpox/monkeypox vaccine candidate.

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library) using Immunotope Inc’s immunoproteomics technologies to identify naturally processed and presented antigens only on infected cells, and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via micro-needles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates are intended to reduce the burden and the logistics of vaccine administration.

Find out more online at  www.emergexvaccines.com.
Visit our LinkedIn page or Twitter account for live updates.

Emergex Confirms Synthesis of a CD8+ T cell Adaptive Vaccine for Smallpox and Monkeypox

– Vaccine construct comprised predominantly of peptides from early “eclipse phase” antigens targeting infections before viral replication is complete

– Peptide sequences of the vaccine construct are derived from variola (smallpox) virus and monkeypox virus antigens of the same viral family (Poxviridae)

– Construct has been synthesised to preclinical grade at Emergex’s in-house manufacturing site. Demonstrates Emergex’s ability to respond rapidly to emerging disease threats by creating experimental vaccine constructs using its highly adaptable, precise plug-and-play technology

Abingdon, Oxon, UK, 18 October 2022 – Emergex Vaccines Holding Limited (‘Emergex’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, announces today that it has formulated and confirmed the synthesis and assembly of a CD8+ T cell Adaptive Vaccine for smallpox and monkeypox, comprised predominantly of early “eclipse phase” antigens

The monkeypox virus is part of the same family of double-stranded DNA viruses (Poxviridae) as variola virus, the virus that causes smallpox; they share many highly conserved proteins that make ideal T cell vaccine targets. Emergex’s current formulation of the vaccine contains 20 viral peptides binding a range of human leukocyte antigens (HLA) that can present to CD8+ T cells to recognize and destroy viral-infected cells. The fact that the vaccine construct’s pathogen peptides come from the “eclipse phase” of viral replication plays a key role in infection kinetics. The “eclipse phase” is defined as the period between the entry of the virus’ genetic material into the host cell, causing infection, and the appearance of new mature virus in a host cell. Emergex’s vaccine construct primes T cells to target an infected cell, with an ideal outcome being an “abortive infection”.(1,2) This is one mechanism of sterilizing immunity;(3,4) however, vaccine-induced immunity can protect against future infection in the absence of sterilising immunity.(5)

The vaccine construct has been synthesised to preclinical grade at Emergex’s in-house GMP manufacturing facility near Oxford with preclinical testing being performed in the laboratories at Emergex USA.

Phillip Williams, Chief Scientific Officer at Emergex commented: “We’re very proud to have synthesized this smallpox and monkeypox vaccine so quickly using intelligence and resources to target highly conserved sequences shared by both viruses. This accomplishment demonstrates our ability to respond rapidly to emerging disease threats by creating experimental vaccines using our highly adaptable plug-and-play technology.”

Professor Thomas Rademacher, Co-Founder and CEO at Emergex added: “The recent global monkeypox outbreak and global shortages of smallpox vaccines highlight the urgent need for societies worldwide to be well prepared in advance of any future disease outbreaks. Our vaccine, which targets highly conserved antigens, is designed to be cross-reactive and convey protection from both smallpox and monkeypox viruses and may also confer protection against other members of the Pox family.”

Smallpox is an acute contagious disease caused by the variola virus, thought to have originated up to 3,000 years ago.(6) It was a devastating disease that caused millions of deaths before the World Health Organization declared that it had been eradicated in 1980,(7) widely considered an international public health triumph demonstrating the power of vaccines. Amongst survivors, the disease often left permanent and debilitating complications, such as severe scarring or blindness. With a fatality rate of >30% in unvaccinated people, there are concerns that smallpox could pose a future biosecurity threat.

Monkeypox is a zoonotic disease that is primarily dominant in tropical rainforest areas in Central and Western Africa. It can be transmitted between people through close contact with body fluids, respiratory droplets, and contaminated materials. Over the last ten months, 68,900 laboratory-confirmed cases of monkeypox and 25 deaths have been reported from 106 countries worldwide, the first time monkeypox has spread widely outside Central and West Africa.(8)

References

1. Swadling L, et al. Pre-existing polymerase-specific T cells expand in abortive seronegative SARS-CoV-2. Nature; 601(7891):110-117. https://doi.org/10.1038/s41586-021-04186-8. Epub 2021 Nov 10.

2. Augusto, DG, et al. A common allele of HLA mediates asymptomatic SARS-CoV-2 infection. medRxiv. https://doi.org/10.1101/2021.05.13.21257065. 2022 Oct.

3. Hepburn MJ, et al. Neutralizing antibody response to booster vaccination with the 17d yellow fever vaccine. Vaccine; 24(15):2843-9. https://doi.org/10.1016/j.vaccine.2005.12.055. Epub 2006 Jan 18.

4. Sanchez-Felipe L, et al. A single-dose live-attenuated YF17D-vectored SARS-CoV-2 vaccine candidate. Nature; 590(7845):320-325. https://doi.org/10.1038/s41586-020-3035-9. Epub 2020 Dec 1.

5. Werner JM, et al. The hepatitis B vaccine protects re-exposed health care workers, but does not provide sterilizing immunity. Gastroenterology; 145(5):1026-34. https://doi.org/10.1053/j.gastro.2013.07.044. Epub 2013 Jul 31.

6. Centers for Disease Control and Prevention – History of Smallpox

7. World Health Organisation Health Topics – Smallpox

8. World Health Organisation Multi country Outbreak of Monkeypox External Situation Report Edition 7 5 October 2022

 

– Ends –

 

For further information, please contact: 

 

Emergex   Consilium Strategic Communications  
Storme Moore-Thornicroft, Executive Director 

Phone: +44 (0) 1235 527589 

Email: smt@emergexvaccines.com 

  

Chris Gardner / Ashley Tapp  

Phone: +44 (0)20 3709 5700 

Email: Emergex@consilium-comms.com 

 

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells in order to provide protection against some of the world’s most urgent health threats: [i] viral infectious diseases, amongst which are Universal Coronavirus, Dengue Fever and Universal Influenza A, including pandemic influenza, as well as [ii] intra-cellular bacterial infectious disease.

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue Fever (which may also be disease-modifying for other members of theFlaviviridae virus family, such as Zika and Yellow Fever) and [ii] Universal Coronavirus. Other programmes in development include vaccine candidates for Universal (pandemic) Influenza, Chikungunya, Hand, Foot, and Mouth Disease, Zika, and a booster vaccine for Yellow Fever. The programmes in the Discovery phase, for which our proprietary ligandome has been developed, include Francisella tularensis (intra-cellular bacterium), and a smallpox/monkeypox vaccine candidate.

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library) using Immunotope Inc’s immunoproteomics technologies to identify naturally processed and presented antigens only on infected cells, and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via micro-needles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates are intended to reduce the burden and the logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.

Emergex Acquires Intradermal and Patch Drug Delivery Technology with Its Manufacturing Equipment from Zosano Pharma

Abingdon, Oxon, UK, 12 October 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, announces that it has acquired the assets of Zosano Pharma Corporation (Fremont, CA).

The assets acquired include intellectual property, license agreements, and manufacturing equipment. They also include Zosano’s proprietary microneedle array patch (MAP) intradermal drug delivery system, including a reusable applicator, solid coated microneedle array patch technology, product packaging, methods for formulation and microneedle coating, and specialized equipment, designed and built for clinical and commercial manufacture of the technology.

Emergex has previously completed proof-of-concept studies, coating Zosano’s MAP technology-based microneedle patches with Emergex vaccine candidates and observed favourable shelf-life characteristics. This acquisition provides Emergex with an innovative MAP delivery technology as well as optimised manufacturing capability for the technology.

Brian Pfister, Vice President at Emergex USA commented: “The vaccines being developed by Emergex have been designed for intradermal administration, and we have been exploring delivery using microneedle patches for some time. We feel that the MAP technology developed by Zosano is an exceptional strategic fit that complements our CD8+ T cell Adaptive Vaccine platform and intend to develop the MAP technology acquired from Zosano for delivery of our vaccines. We look forward to future clinical study with our vaccine coated patches.”

Intradermal Delivery of Vaccines and MAP Technology

The human skin is rich in antigen-presenting cells. It has been proposed that delivery of vaccine antigens to/through the skin (i.e., intradermal delivery) rather than to muscle or subcutaneous tissue could therefore induce superior protective immune responses while using smaller quantities of vaccine antigen. Additionally, MAP technology may reduce or eliminate the cold chain logistics from manufacture to use location and enable vaccine doses being shipped directly to patients, thereby making vaccines more accessible. Such an approach has potential to greatly streamline “the last mile” of vaccine administration globally.

– Ends –

 

For further information, please contact:

 

Emergex Consilium Strategic Communications
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Chris Gardner / Ashley Tapp

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells in order to provide protection against some of the world’s most urgent health threats: [i] viral infectious diseases, amongst which are Universal Coronavirus, Dengue Fever and Universal Influenza A, including pandemic influenza, as well as [ii] intra-cellular bacterial infectious disease.

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue Fever (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and [ii] Universal Coronavirus. Other programmes in development include vaccine candidates for Universal (pandemic) Influenza, Chikungunya, Hand, Foot, and Mouth Disease, Zika, and a booster vaccine for Yellow Fever. The programmes in the Discovery phase, for which our proprietary ligandome has been developed, include Francisella tularensis (intra-cellular bacterium), and a smallpox/monkeypox vaccine candidate.

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library) using Immunotope Inc’s immunoproteomics technologies to identify naturally processed and presented antigens only on infected cells, and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via micro-needles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates are intended to reduce the burden and the logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.
Visit our LinkedIn page or Twitter account for live updates.

Emergex Announces GMP Production of its CD8+ T cell Universal Influenza Vaccine

  • Emergex will manufacture the candidate universal influenza vaccine to cGMP standards for use in Phase I human trials
  • Emergex’s universal influenza vaccine is a radically different approach to inducing influenza immunity by employing the use of a combination of:
  1. Highly conserved Class I peptides from non-structural proteins (NSP) representative of pandemic influenza A strains which have occurred since 1918,
  2. Class I peptides from a negative sense open reading frame (ORF) that evolved and varied at ~50-year H1N1 pandemic intervals, defining the subsequent imprinted generational immunity.

Abingdon, Oxon, UK, 28 July 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, announces the manufacture of its universal/pandemic influenza vaccine, ready for Phase I clinical trials.

Emergex has announced an important move into cGMP (ready for human clinical trials) production of their influenza vaccine candidate. Influenza A is a segmented RNA virus and circulates as a quasi-species cloud. Conventional influenza vaccines offer limited efficacy relying upon the production of antibodies to provide immunotherapy. This approach can potentially prevent birth cohort imprinted T cell immunity in children with later life consequences. Emergex’s vaccine works differently by prime/activating influenza specific CD8+ T cells that recognise these same peptides when presented on the surface of infected cells and kill the infected cell during the eclipse phase – therefore preventing virion production. The vaccine is designed to induce CD8+ T cells specific to highly conserved parts of the influenza virus from both the positive and negative sense reading frames. This approach has the potential to transform the global approach to influenza and pandemic influenza strategies, removing the requirement for strain specific vaccines and offer extended immune protection and importantly offer protection against future pandemic strains.

Emergex has pioneered T cell vaccination and was the first vaccine to be approved for clinical trials based on inducing a CD8+ T cell response without relying upon antibodies. The first Phase I clinical trials (Dengue and COVID 19) have demonstrated that the platform potential of the vaccine platform in humans. The extension of the vaccine platform to non-canonical reading frames – and targeting viral peptides that are generated in the pioneer round and expressed during the eclipse phase of viral replication and are highly conserved in their nature – marks an important step forward for Emergex and global immunisation strategies.

Type A influenza strains have been responsible for H1N1 pandemics usually on 50-year cycles in contrast to Type B influenza. Localized influenza epidemics of variable severity occur annually worldwide in all age groups, typically during the winter months in temperate climates. These annual epidemics are thought to result in 3 million to 5 million cases of severe illness and approximately 250,000 to 500,000 deaths every year around the world (WHO, 2005).

Laurens Rademacher, Chief Technology Officer at Emergex commented: “Advancing into cGMP production is an important milestone for the Emergex Universal Influenza Vaccine candidate. Having completed preclinical safety and proof of mechanism (POM) efficacy studies, we are now confident this vaccine is ready to be added to our clinical pipeline along with our Dengue and Coronavirus vaccine candidates. By targeting novel and conserved areas of the Influenza virus, we believe that our approach could provide a long-term solution against the global threat of both seasonal and future pandemic Influenza.”

– 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, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

Chris Gardner / Ashley Tapp

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells in order to provide protection against some of the world’s most pressing health threats: [i] viral infectious diseases, amongst which are Dengue, Coronaviruses, and pandemic Influenza, as well as [ii] serious intracellular bacterial infectious diseases.

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and [ii] Coronaviruses. Other programmes in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via microneedles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates are intended to reduce the burden and the logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page or Twitter account for live updates.

Emergex Vaccines signs Heads of Terms for a Collaboration with Molecular Biology Institute of Paraná (IBMP) in Brazil

Abingdon, Oxon, UK, 1 July 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, today announced that it has signed heads of terms for a collaboration with the Molecular Biology Institute of Paraná (IBMP) in Brazil.

 

IBMP is a commercial organisation with close links to Fiocruz, the most important national institution for research and production of biopharmaceuticals and vaccines linked to the Ministry of Health in Brazil. It has a strong commercial track record in the healthcare space with expertise in the development, manufacturing, regulatory approval and commercialisation of medical diagnostics and medicines in Brazil.

 

The agreement, once fully executed, will involve a shared clinical development phase as well as allowing IBMP exclusive rights for the commercialisation of the vaccine candidates in Brazil. In addition, clinical stage manufacturing of the vaccines will be conducted by Emergex with a transition to commercial scale manufacturing being conducted in the region by IBMP. A Joint Steering Committee with representatives from both Emergex and IBMP will oversee the collaboration and commercialisation of the vaccines in Brazil.

 

The agreement initially focuses on Emergex’s Dengue vaccine candidate and also includes the shared development and commercialisation of COVID-19 and Chikungunya vaccine candidates. Emergex’s Dengue and COVID-19 vaccine candidates are currently in Phase I clinical trials in Switzerland with top line results for Dengue expected imminently and top line results for COVID-19 expected later this year.

 

The collaboration also involves Emergex and IBMP conducting pre-clinical testing and clinical development of Chikungunya vaccine candidate. The Chikungunya vaccine candidate is being developed with support from a UK Aid grant, (Official Development Assistance). This was awarded to Emergex following a Small Business Research Initiative (SBRI) competition, funded by the Department of Health and Social Care’s (DHSC) UK Vaccine Network (UKVN), delivered through Innovate UK, to develop vaccines for diseases with epidemic potential in low- and middle-income countries. Further development of the Chikungunya vaccine candidate in Brazil would be jointly conducted by Emergex and IBMP with costs shared equally between both parties and with IBMP having the option for exclusive commercial rights for the Chikungunya vaccine in Brazil.

 

Emergex’s previous collaboration with a related Brazilian institution resulted in an excellent working relationship and the generation of valuable pre-clinical data for Emergex’s CD8+ T cell adaptive COVID-19 vaccine, currently in completion for a Phase I clinical trial in Switzerland. This previous collaboration was also an important building block, in building trust and strengthening our relationships in Brazil, and was pivotal in us achieving this agreement with the IBMP.

 

Robin Cohen, Chief Commercial Officer at Emergex, commented: “This is an important step as we look ahead and plan for the development of our lead vaccine candidates. Dengue is a serious endemic disease in Brazil and we are delighted to be bringing forward our vaccine technology that has the potential to better protect the health for millions of people in the region. Partnering with IBMP makes strategic sense for Emergex as it has the local contacts and expertise to successfully develop and commercialize our vaccines in Brazil. We look forward to completing the formal agreement in due course.”

 

– 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, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

 

Brian Pfister, Vice President, Emergex USA

Phone: +1 847-421-0253

Email: bp@emergexvaccines.com

Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells in order to provide protection against some of the world’s most pressing health threats: [i] viral infectious diseases, amongst which are Dengue, Coronaviruses, and pandemic Influenza, as well as [ii] serious intracellular bacterial infectious diseases.

 

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and [ii] Coronaviruses. Other programmes in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.

 

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via microneedles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates are intended to reduce the burden and the logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page or Twitter account for live updates.

 

 

About IBMP

With a broad and modern manufacturing plant, the Molecular Biology Institute of Paraná (IBMP) works in applied research, technological development, innovation and industrial production of inputs and diagnosis kits for health. The institution integrates and contributes to the development of the Economic and Industrial Complex of Health (Complexo Econômico e Industrial da Saúde – CEIS) and comprehends the development of Science and Technology as the best access to health products, services, and fundamental for the economic dynamism in the country. Its activities are intended to supply the health network with safe and quality products.

Find out more online at https://www.ibmp.org.br/en-us/.

Emergex Vaccines Announces the Successful Coating of its Novel CD8+ T cell Adaptive COVID-19 Vaccine onto Zosano Pharma’s Micro-Needle Patch

 –  Emergex’s COVID-19 and Dengue CD8+ T cell Adaptive vaccines are already in clinical trials

 

Abingdon, Oxon, UK, 17th May 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, today announced that its COVID-19 vaccine candidate has been successfully coated onto Zosano Pharma Corporation’s (NASDAQ:ZSAN) proprietary microneedle patch system. Zosano’s patch consists of an array of approximately two thousand drug-coated titanium microneedles mounted on an adhesive patch that is administered to the skin using a reusable applicator.

Emergex and Zosano have demonstrated that Emergex’s COVID-19 vaccine is stable on the patches over a wide temperature range for up to six months at 40oC/75% relative humidity. Reducing cold chain logistics to a minimum may allow less costly and efficient vaccination programs around the world and increase global preparedness for future pandemics and disease outbreaks.

Emergex CD8+ T cell Adaptive Vaccine for COVID-19 offers the potential for long-term immune protection, thereby avoiding the need for seasonal boosting, and its broad protection is less likely to be impacted by changes (mutations) in the consensus sequence in RNA viruses leading to new variants of concern. Combining Emergex’s novel vaccine platform with Zosano’s innovative microneedle patch brings innovation in both immunological protection and delivery routes which may benefit global communities across many different infectious diseases.

Mahmoud Ameri, Ph.D., Vice President of research and development at Zosano, commented: “We are pleased to have successfully reached this six-month milestone with a COVID-19 vaccine candidate onto our microneedle patch system and to collaborate with Emergex.”

 

Robin Cohen, Chief Commercial Officer at Emergex, commented: “Vaccine delivery is a critical component in the global effort both to prepare for future pandemics and to prevent disease outbreaks in communities around the world. Our T cell Adaptive Vaccine technology has the potential to provide broad immune protection – covering viral strains and escape mutations as well as cellular immune memory that may last for decades. Combining this ground-breaking approach to vaccination with innovative, easy-to-use patch delivery could radically transform the vaccine landscape. We are delighted to have worked with Zosano on this exciting project.”

– 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, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

 

Brian Pfister, Vice President, Emergex USA

Phone: +1 847-421-0253

Email: bp@emergexvaccines.com

 

Zosano Pharma

Christine Matthews, Chief Financial Officer
Phone: +1 510-745-1200

Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

Wheelhouse Life Science Advisors (Zosano PR)

Sylvia Wheeler/ Alexandra Santos
Email: swheeler@wheelhouselsa.com
or asantos@wheelhouselsa.com

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells in order to provide protection against some of the world’s most pressing health threats: [i] viral infectious diseases, amongst which are Dengue, Coronaviruses, and pandemic Influenza, as well as [ii] serious intracellular bacterial infectious diseases.

 

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and [ii] Coronaviruses. Other programmes in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.

 

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via microneedles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates are intended to reduce the burden and the logistics of vaccine administration.

 

Find out more online at www.emergexvaccines.com.
Visit our LinkedIn page or Twitter account for live updates.

 

About Zosano Pharma

Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s transdermal microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients.

Learn more at www.zosanopharma.com.

 

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding efficiency, cost and potential of Emergex’s vaccination program,  the benefits and potential uses of Zosano Pharma’s transdermal microneedle system and other future events and expectations described in this press release. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “scheduled,” “goal,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the company’s ability to continue operations, successfully restructure its indebtedness or complete any strategic transactions and other risks and uncertainties described under the heading “Risk Factors” in the company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

Emergex Provides an Update on First-in-Human Studies of Its Novel Dengue Fever and Coronavirus T cell Adaptive Vaccines

– Both studies fully recruited, with data from the Dengue Fever study anticipated in the summer

– Preclinical data for Emergex’s Coronavirus vaccine candidate suggests that it could provide heterologous immunity to viruses from the same family

Abingdon, Oxon, UK, 18 April 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, today provided an update on its first-in-human clinical trials of its Dengue and Coronavirus T cell Adaptive Vaccine candidates.

As part of the clinical development of its novel T cell Adaptive Vaccines, Emergex has introduced an innovative clinical trial design where two vaccine candidates based on the same platform technologies, one against Dengue fever and one against Coronavirus disease, are assessed in two stages of a Phase I clinical trial at a single site in Switzerland (Unisanté, Lausanne) with 52 participants. The two stages of the trial are designed to evaluate the safety and tolerability of the vaccine candidates in a double-blind, randomised, dose-ranging, and comparator-controlled setting. An independent Data Safety Monitoring Board has been monitoring the clinical trial.

naNO-Dengue study: The Company has successfully completed the Phase I clinical trial for its novel CD8+ T cell Dengue vaccine candidate. The Last Participant Last Visit per clinical trial protocol for the trial (NCT04935801) was performed on 11 March 2022. In the trial, two dose levels of the Emergex CD8+ T cell Dengue vaccine candidate were evaluated in 26 healthy adults aged 18 to 45 years. Follow up with trial participants has taken place over a six-month period following first injection and the final clinical trial report is nearing completion. The results are expected to be announced in the summer.

naNO-COVID study: The Phase I clinical trial (NCT05113862) for the Company’s novel CD8+ T cell Coronavirus vaccine candidate is ongoing with first participant dosed on 10 January 2022. All 26 healthy adults aged 18 to 45 years in the ‘naNO-COVID’ trial have received vaccinations (lower-dose or higher-dose) of the Emergex CD8+ T cell vaccine against Coronavirus disease and are now in the follow-up period per the clinical trial protocol. The Lausanne-based trial coincided with the January-March Omicron wave of SARS-CoV-2 in Switzerland. During this time, the seven-day average of new cases peaked at 30-40,000 new cases per day, representing a significant increase over prior time periods. The trial remains blinded (comparator controlled) and participants are being monitored for virologically confirmed symptomatic disease.

Preclinical data for the Company’s novel CD8+ T cell Coronavirus vaccine candidate in HLA transgenic mice has confirmed that after vaccination with the Company’s T cell Coronavirus vaccine candidate and subsequent SARS-CoV-1 intranasal challenge, no lung inflammation was detected which suggests that the vaccine candidate demonstrates heterologous protection for both viruses from the same family.

Future Studies: Phase I/II and II/III Clinical trials for both vaccine candidates are planned, in the near-term, for South-East Asia, USA, South America and Middle East.

Dr. Athanasios Papadopoulos, Chief Medical Officer, commented: “Over the past year, Emergex has made substantial progress in advancing its clinical programmes with a platform that is designed to boost T cell immunity against any infectious agent. The 52 participants enrolled in the naNO-Dengue and naNO-COVID Phase I trials represent a significant milestone for the Company, and I remain optimistic for when the data from these studies is unblinded. Both of these vaccines are a direct result of Emergex’ work to advance its CD8+ T cell Adaptive Vaccine platform to address a diversity of viral and bacterial disease threats. As it becomes available, I look forward to reporting the data from these ongoing clinical studies as well as our future clinical programme plans.”

– 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, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells for protection against some of the world’s most pressing health threats: [i] viral infectious diseases, amongst which are Dengue, Coronaviruses, and pandemic Influenza, as well as [ii] serious intracellular bacterial infectious diseases.

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and [ii] Coronaviruses. Other programmes in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via micro-needles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates as intended reduce the burden and logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.
Visit our LinkedIn page or Twitter account for live updates.

Emergex Advances Vaccine Candidate for Tularemia, Highlighting the Potential of T cell Priming Vaccines in National Preparedness Initiatives

· Emergex’s CD8+ T cell Adaptive Vaccine platform will now be used to generate a tularemia vaccine candidate that provides a cytotoxic (killing of infected cells) CD8+ T cell response and offers a means for rapid development suitable for deployment as a medical countermeasure.

· Emergex’s ongoing Phase I clinical trials on vaccine candidates for Dengue Fever and COVID-19 are evaluating safety and immunogenicity of the technology platform, using selected viral peptides and a self-adjuvating passivated gold nano particle carrier system, with final data expected this summer for the Dengue candidate.

· Francisella tularensis, the causative agent of tularemia, is a highly virulent intracellular bacterial pathogen that is currently considered a potential national security biothreat by the US government.

· Emergex previously reported the successful characterization of the MHC Class I CD8+ epitope ‘ligandome library’ for F. tularensis epitopes. Emergex has a growing pipeline of vaccine candidates for diverse viral and intracellular bacterial pathogens that require CD8+ T cells for protection. Typical infectious diseases caused by intracellular bacteria include brucellosis, listeriosis, tuberculosis and gonorrhea.

Abingdon, Oxon, UK, 14 April 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or ‘the ‘Company’), a company addressing major global infectious disease threats through the development of fully synthetic CD8+ T cell Adaptive Vaccines, today announces that it is progressing preclinical development of its intracellular bacterial vaccine candidate for Francisella tularensis following the completion of successful ligandome generation (as previously reported). Emergex now plans to combine that technology with its CD8+ T cell Adaptive Vaccine platform.

Emergex intends to use its previously determined repertoire of Class I peptides to generate a CD8+ T cell Adaptive Vaccine as a medical countermeasure for better preparedness against naturally occurring, accidental, or deliberate exposures to the bacterium that causes tularemia. Protection against Francisella tularensis is thought to be conferred and essential by CD8+ T cell-mediated immunity,1 in contrast to humoral factors such as antibodies.

Professor Thomas Rademacher, CEO and co-founder of Emergex, commented: “Emergex recognizes the importance of effective medical countermeasure development for a diversity of viral and intracellular bacterial threats. We believe that the field of T cell priming vaccines can play an important role in national preparedness initiatives. Next generation vaccines, such as our T cell Adaptive Vaccines, will enable the induction of targeted T cell immunity via priming of naïve T cells that recognize and remove infected cells and thereby cut short the infection cycle, sparing that person.”

 

Tularemia is a zoonotic infectious disease, categorized by symptoms including fever, skin ulcers, and occasionally pneumonia, and is found throughout the Northern Hemisphere. The intracellular bacterium is spread from animals (rodents, hares and rabbits) to humans most commonly through arthropod vectors (tick and deer fly bites), by drinking contaminated water, or through direct contact with infected animals.2 There are currently no approved vaccines for tularemia prevention, and subsequent infection is managed with antibiotic therapy.

 

Bioagents are categorized according to assessment of their risk to national security and are continuously monitored by governments as biodefense response strategy evolves. Tularemia is classified as a category A biothreat along with anthrax, smallpox, plague, viral hemorrhagic fevers (such as Ebola), and is considered a potential national security biothreat by the US government.

 

Category A biothreats, whether through natural, deliberate, or accidental exposure, are pathogens that pose the highest risk because they can: [i] easily be disseminated or transmitted, [ii] bear a high mortality rate and public health impact, [iii] require special public health preparedness actions, and [iv] have the potential to cause public panic and social disruption.3,4

 

– Ends –

 

1 Place DE, Williamson DR, Yuzefpolskiy Y, Katkere B, Sarkar S, Kalia V, Kirimanjeswara GS. Development of a novel Francisella tularensis Live Vaccine Strain expressing ovalbumin provides insight into antigen-specific CD8+ T cell responses. PLoS One. 2017 Dec 28;12(12):e0190384. doi: 10.1371/journal.pone.0190384. PMID: 29284034; PMCID: PMC5746256

2 https://www.cdc.gov/tularemia/index.html
3 https://emergency.cdc.gov/agent/agentlist-category.asp
4 https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens

 

 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, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells for protection against some of the world’s most pressing health threats, including viral infectious diseases such as Dengue Fever, COVID-19, pandemic Influenza, as well as serious intra-cellular bacterial infections.

Emergex has a growing pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are Dengue Fever (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and

_____________________

Yellow Fever), as well as COVID-19. Other programmes in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via micro-needles to elicit a robust adaptive CD8 T cell response. With potential stability at ambient temperatures, the vaccine candidates as intended reduce the burden and logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.
Visit our LinkedIn page or Twitter account for live updates.

Emergex Signs Agreement with ATCC to Advance Studies of its Yellow Fever Booster Vaccine Candidate

Abingdon, Oxon, UK, 7 April 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a company addressing major global infectious disease threats through the development of fully synthetic CD8+ T-Cell Adaptive Vaccines, today announces that it has entered into an agreement with ATCC to progress preclinical development of its Yellow Fever booster vaccine program. ATCC is a non-profit organization that collects, stores, and distributes standard reference microorganisms, cell lines and other materials for research and development.

In August 2020, researchers at Emergex reported the first analysis of T-Cell epitopes produced by an existing live attenuated commercial Yellow Fever 17D (YF17D) vaccine. Emergex now plans to perform a comparative study using the wildtype Yellow Fever virus: these comparison studies of the Class I CD8+ T-Cell epitopes derived from both live attenuated and wildtype viruses will further support the development of Emergex’s T-Cell Yellow Fever booster vaccine candidate.

The agreement with ATCC is expected to enable Emergex to perform safely its studies with the wildtype Yellow Fever virus, classified as a BioSafety level 3 pathogen [BS3], to advance development of its T-Cell booster vaccine candidate. ATCC will oversee and perform viral infection models – infecting human cell lines with wild-type Yellow Fever virus. Emergex will then conduct immunoproteomics analyses of the MHC Class I-presented viral peptides on infected cell surfaces to confirm the expression library of viral epitope peptides presented to CD8+ T-Cells. The anticipated results, together with earlier data derived from the live attenuated virus, are expected to allow for the development of an effective next-generation Yellow Fever vaccine capable of meeting an increasing global vaccine demand.

Professor Thomas Rademacher, co-founder and Chief Executive Officer of Emergex Vaccines commented: “Emergex is making progress in advancing a T-Cell Adaptive booster vaccine candidate through its confirmatory ligandome studies using wildtype Yellow Fever virus may be a promising solution for ongoing protection as this infectious disease continues to re-emerge and spread worldwide. While the current YF17D vaccine is considered effective, reliance on immunisation as primary protection against the disease on its own is potentially unsustainable in the long-term. This conclusion is important because many individuals in endemic regions with primary Yellow Fever immunisation may require a booster to ensure continued protection, thus exacerbating existing vaccine shortages. Investment in next-generation Yellow Fever primary vaccines and boosters is therefore critical to providing additional supply of treatments in order to meet the increasing global demand and to minimize the side effects of YF17D.”

– 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, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T-Cell Adaptive Vaccines that harness the body’s natural T-Cell immune response to destroy pathogen-infected cells for protection against some of the world’s most pressing health threats.

Emergex has a growing pipeline of innovative CD8+ T-Cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are Dengue fever (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever), as well as coronavirus. Other programmes in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.

Emergex’s T-Cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via micro-needles to elicit a robust adaptive resident CD8 T-Cell response. With potential stability at ambient temperatures, the vaccine candidates as intended reduce the burden and logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.
Visit our LinkedIn page or Twitter account for live updates.

 

About ATCC

ATCC is a premier global biological materials and information resource and standards organization and the leading developer and supplier of authenticated cell lines and microorganisms. With a history of scientific advancements spanning nearly a century, ATCC offers an unmatched combination of being the world’s largest and most diverse collection of biological research solutions and a mission-driven, trusted partner that supports and encourages scientific collaboration. ATCC products, services and people provide the scientific community with credible biological products and advanced model systems that support complex research in a variety of innovative applications resulting in incredible achievements in basic science, drug discovery, translational medicine and public health. ATCC is a nonprofit organization with headquarters in Manassas, Virginia, and a research and development innovation center in Gaithersburg, Maryland. To learn more, visit atcc.org.

About Yellow Fever:

Yellow Fever is a severe, potentially fatal, mosquito-borne disease endemic to tropical and subtropical regions of Africa, Central and South America. There are 47 at-risk countries in these regions and a growing prevalence of cases being reported in countries once considered non-endemic, causing concern for future outbreaks.1 Despite the availability of an approved vaccine in use since the 1930’s, Yellow Fever continues to be a significant threat to public health and necessitates preparedness for future outbreaks and international spread as global travel accelerates and global warming intensifies the habitat of the pathogen-bearing mosquitos.

Recent outbreaks in major metropolises have led to fractional dosing initiatives in attempts to stretch vaccine access and vaccine supplies as mass vaccination campaigns are needed.2 The need to address the increased threat of Yellow Fever outbreaks with global spread has been recognised by the WHO in its establishment of the Eliminate Yellow Fever Epidemics (“EYE”) initiative.3

 

1 https://www.who.int/news-room/fact-sheets/detail/yellow-fever

2 https://www.mdpi.com/1424-8247/14/9/891/htm

3 https://www.who.int/initiatives/eye-strategy

 

The live attenuated YF17D vaccine is produced exclusively via embryonic chicken eggs with safety testing in non-human primates, per WHO safety requirements, contributing to limited global YF17D vaccine production (thus produced by only 4 certified manufacturers).

Furthermore, YF17D comes with the additional challenge of rare, yet serious, adverse events, including Yellow Fever vaccine-associated neurotropic disease (YEL-AND) and -associated viscerotropic disease (YEL-AVD) among certain susceptible populations.4 The vaccine is contraindicated in at-risk populations due to its live-attenuated nature.

Emergex Awarded £490,525 UK Aid Grant by the Department of Health and Social Care to Advance Synthetic T cell Vaccine Candidate for Chikungunya Virus

Abingdon, Oxon, UK, 22 February 2022 – Emergex Vaccines Holding Limited (‘Emergex’, or ‘the Company’), a company tackling major global infectious disease threats through the development of 100% synthetic Priming T cell Adaptive Vaccines, today announces that it has been awarded a £490,525 grant by the UK government’s Department of Health and Social Care (‘DHSC’) to advance a synthetic T cell vaccine candidate for Chikungunya virus.

The grant will cover the cost of generating a Chikungunya vaccine prototype. The project covers the identification of novel Chikungunya peptide epitopes (collectively constituting the “ligandome”), synthesis of a vaccine candidate and testing in in vitro efficacy models.

The funding, administered through UK Aid (Official Development Assistance) funding, was awarded following a Small Business Research Initiative (SBRI) competition funded by the DHSC’s UK Vaccine Network (UKVN), delivered through Innovate UK. The SBRI awarded grants totalling £10 million to 22 research projects that address vaccine development for the UKVN’s 12 priority pathogens with epidemic potential in low- and middle- income countries (LMICs), including Ebola, Zika, Lassa Fever, Crimean-Congo Haemorrhagic Fever (CCMF), among others. The UKVN was established in response to the 2015 West Africa Ebola outbreak which highlighted the significant potential threat posed by Ebola and other virus pathogens.

Emergex will generate a fully synthetic Priming CD8+ T cell Adaptive Vaccine candidate by targeting regions of the Chikungunya virus that are common amongst all Togaviridae viruses. The vaccine, as with all of Emergex’s vaccine candidates, combines two proprietary technologies comprised of [i] identification of viral protein fragments (otherwise known as peptides or ligands) carefully selected from an empirical viral code repository, or “ligandome” library, and [ii] a gold nanoparticle carrier, designed to deliver the selected peptides to the epidermis via micro-needles to promote natural long-term protective skin cellular immunity to mosquito-borne infections. The T cell priming vaccines have already shown to be safe in two ongoing clinical trials for dengue and SARS-CoV-2. When combined, the technologies constitute a 100% synthetic vaccine construct for Chikungunya and potentially other alphaviruses. Vaccine characteristics enable stability at ambient temperatures, suitable for the LMICs where Chikungunya is endemic and most prevalent.

Professor Thomas Rademacher, Founder at Emergex Vaccines, commented: “We are pleased to have been awarded this grant that will allow us to contribute to the global fight against mosquito-borne infections and recognize that the UK government and its advisers see the potential of our innovative technology. Emergex is developing next-generation priming T cell adaptive vaccines, which cover a range of viral and intracellular bacteria including COVID-19, dengue, influenza, etc., are designed to deliver broad and long-lasting immunity by preventing infected cells from progressing to a productive infection.”

Sajid Javid, Secretary of State for Health and Social Care of the United Kingdom, said: “I am delighted that these innovative projects – tackling serious and deadly diseases – will receive the funding they need to take their research to the next stage.”

Chikungunya (Primary and Chronic) virus, is a potentially severe mosquito-borne infection of the Togaviridae viral family, characterized by fever and joint pain, with a high public health burden of over 1 billion a year in reported cases in widespread endemic regions (the Americas, Europe, Asia, and Africa). It is an emerging pathogen of concern that poses a threat to temperate regions and has recently increased in severity of outbreaks. Already endemic to five continents, there is a looming risk that it will be transported to new regions. Currently there is no vaccine to prevent, or therapy to treat, Chikungunya patients.

– 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, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is tackling some of the world’s most immediate health threats, including viral diseases such as dengue fever, COVID-19, Zika, Ebola, pandemic influenza, as well as serious intra-cellular bacterial infections, by pioneering the development of 100% synthetic Priming T cell Adaptive Vaccines that harness the natural immune response to prime T cells to destroy pathogen-infected cells.

Emergex is developing a pipeline of innovative Priming CD8+ T cell Adaptive Vaccine candidates, which have the potential to deliver rapid, broad (mutation-agnostic), and long-lasting (decades-long) immunity to reduce serious illness associated with infectious diseases. Emergex has a number of Phase I clinical trials underway, with the most advanced development programmes for COVID-19 and dengue vaccine candidates. Other programmes in development include vaccine candidates for universal (pandemic) influenza, hand foot and mouth disease, a hepatitis B therapeutic, and a yellow fever booster.

Emergex’s Priming T cell Adaptive Vaccines use purely synthetic, non-biological compounds and a gold nanoparticle carrier system to deliver a carefully selected set of peptides intradermally via microneedle skin patch to promote the natural cellular immune response, priming T cells to recognise subsequent pathogens much like a natural infection would do, subclinically preventing acute or severe manifestation of the disease. The vaccine technology is designed to elicit a T cell response to highly conserved regions of the pathogen across viral strains, for which selective pressure for mutation is minimal, offering the potential for cross-reactive protective immune responses against families of viruses (such as Flaviviridae, providing protection against Zika and yellow fever).

Added benefits of Emergex’s synthetic Priming T cell Adaptive Vaccine candidates include the potential for stability at ambient temperatures, which should avoid the need for, and resource limitations associated with the cold-chain and transportation to endemic regions.

Drawing on a rich scientific heritage and extensive international research, Emergex has developed collaborations in the US, EU, Singapore, and Brazil with leading vaccine research bodies, including George Mason University in the US, the Institute of Molecular and Cell Biology (IMCB) of Singapore, and Brazil-based Bio-Manguinhos/Fiocruz

Find out more online at www.emergexvaccines.com.

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About the UK Vaccine Network

The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer. This investment is part of the UK Vaccine Network (UKVN). UKVN was established to provide funding to support the development of promising vaccines and vaccine technologies that will help combat infectious diseases that have epidemic potential in low and middle-income countries (LMICs). UKVN is a £120m UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs).

Find out more online at www.gov.uk/government/groups/uk-vaccines-network