Emergex confirms its next generation T-Cell Priming COVID-19 vaccine candidate has the potential to be effective against all currently sequenced viral mutations

  • Emergex confirms that the viral peptides in its COVID-19 vaccine candidate are present in the following sequenced variants, including B.1.1.7(Alpha, UK), B.1.1.28 (Gamma, Brazil) B.1.351 (Beta, South Africa), B.1.429 (South Carolina) B.1.617.2 (Delta, India), B.1.1.529 (Omicron, multiple countries) – meaning that no impact on the efficacy of the vaccine is anticipated
  • Emergex’s COVID-19 vaccine uses highly conserved viral peptides in its vaccine candidate, reducing the chance of viral mutations that would impact vaccine efficacy
  • Emergex vaccine is designed to offer broad immunity against SARS-CoV-1 and all SARS-CoV-2 variants and provide long-lasting and broad, cross-reactive immunity that does not require seasonal booster vaccine

Abingdon, Oxon, UK, 30 November 2021 – Emergex Vaccines Holding Limited (‘Emergex’, or ‘the Company’), a company tackling major global infectious disease threats through the development of 100% synthetic T-Cell priming vaccines today confirms that its vaccine candidate for SARS-CoV-2, the virus which causes COVID-19, has the potential to be effective against all currently known variants.

Emergex has initiated a Phase I trial of the vaccine candidate at the Center for Primary Care and Public Health at the University of Lausanne, Switzerland. The first patient is anticipated to receive their first dose at the start of January 2022.

Professor Thomas Rademacher, Founder at Emergex Vaccines, commented: “Our T-Cell priming vaccines have been designed to offer significant benefits over current COVID-19 vaccines including broader protection against new variants and longer lasting immunity. The emergence of the latest variant highlights the potential importance of such an approach in managing a dynamically changing pandemic situation. We look forward to continuing to gather data to support the development of this important next generation vaccine.”

Emergex’s vaccines aim to prime naive CD8+ T-Cells to generate virus specific CTLs (CD8+ T-cells/Cytotoxic T Lymphocytes) to kill viral infected cells, preventing viral replication and disease and reducing symptoms and the transmissibility between infected and non-infected individuals. As a result, Emergex’s T-Cell priming vaccines have the potential to be more effective in targeting rapidly mutating viruses such as SARS-CoV-2 and eliminate the need for seasonal booster vaccines in comparison to current vaccine technologies, which primarily rely on an antibody immune response. In addition, Emergex’s vaccine is raised against antigens that are highly conserved so may provide cross reactive immunity to SARS-CoV-1 infection and all SARS-CoV-2 variants and strains of the virus, offering broad immune protection from two pandemic viruses in one vaccine.

Emergex vaccines have been designed to be administered via the skin using microneedles and to be stable at ambient room temperature for beyond three months, facilitating rapid and efficient distribution across the world and making administration of the vaccine more patient friendly.

 

– 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 / Aaron Kelly

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 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 announces approval to initiate Phase I clinical trial of its next generation COVID-19 vaccine candidate

  • Synthetic vaccine designed to prime T-Cells to rapidly remove viral-infected cells from the body after infection
  • May offer broad immunity against SARS-CoV-1 and all SARS-CoV-2 variants and provide long-lasting immunity that does not require seasonal booster vaccines

Abingdon, Oxon, UK, 15 November 2021 – Emergex Vaccines Holding Limited (‘Emergex’, or ‘the Company’), a company tackling major global infectious disease threats through the development of 100% synthetic T Cell priming vaccines today announces that it has received the necessary regulatory approvals to initiate a Phase I clinical trial to evaluate the safety and tolerability of its vaccine candidate for SARS-CoV-2, the virus which causes COVID-19.

The Phase I trial is a double-blind, randomised and comparator-controlled study of two groups of 13 volunteers at high and low doses. In addition to providing safety and tolerability data, early data on CD8+ T-Cell mediated immune responses as a surrogate of protection against COVID-19 will be provided. The trial will be conducted by Professor Blaise Genton, Principal Investigator, from the Center for Primary Care and Public Health at the University of Lausanne, Switzerland. The first patient is anticipated to receive their first dose of Emergex vaccine candidate at the start of January 2022.

A Phase I clinical trial (NCT04935801), named naNO-DENGUE, testing Emergex’s Dengue vaccine candidate is currently underway in Switzerland with all patients having received two vaccine doses.

Robin Cohen, Chief Commercial Officer at Emergex Vaccines, commented: “Our T Cell priming vaccines may offer significant benefits over current COVID-19 vaccines including longer lasting immunity and broader protection against new variants. We are proud to announce the initiation of this trial and look forward to gathering data to support the development of this important next generation vaccine.”

Professor Blaise Genton, Principal Investigator for the trial from the Center for Primary Care and Public Health (Unisante) at the University of Lausanne, Switzerland commented: “Although current COVID-19 vaccines have made significant progress in reducing mortality and morbidity challenges still remain, especially with the development of new variants. This exciting new scientific approach to developing a vaccine against SARS-CoV-2 addresses the need to generate a T-Cell response to elicit long term immunity. We look forward to evaluating the results as when they are available.”

Emergex’s vaccines aim to prime naive CD8+ T-Cells to generate virus specific CTLs (CD8+ T-cells/Cytotoxic T Lymphocytes) to kill viral infected cells, preventing viral replication and disease and reducing symptoms and the transmissibility between infected and non-infected individuals. As a result, Emergex’s T-Cell priming vaccines have the potential to be more effective in targeting rapidly mutating viruses such as SARS-CoV-2 and eliminate the need for seasonal booster vaccines in comparison to current vaccine technologies, which primarily rely on an antibody immune response. In addition, Emergex’s vaccine is raised against antigens that are highly conserved so may provide cross reactive immunity to SARS-CoV-1 infection and all SARS-CoV-2 variants and strains of the virus, offering broad immune protection from two pandemic viruses in one vaccine.

Emergex vaccines have been designed to be administered via the skin using micro needles and to be stable at ambient room temperature for beyond three months, facilitating rapid and efficient distribution across the world and making administration of the vaccine more patient friendly.

– Ends –

For further information, please contact:

Emergex

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

Consilium Strategic Communications
Chris Gardner / Ashley Tapp / Aaron Kelly
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 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.

Next-generation COVID-19 vaccines – looking beyond spike protein and SARS-CoV-1 variants

The response to COVID-19 – a success story in vaccine development

The accelerated development of vaccines against COVID-19 and their deployment in mass vaccination programmes has been a major public health achievement. The landscape of vaccine development has undergone rapid change in the global response to the pandemic, with the utilization of novel platforms to create new vaccines at an unprecedented speed. Despite the success of current vaccines in mitigating the threat of severe disease from SARS-CoV-2 infection, there are some ongoing challenges, and the optimization of COVID-19 vaccines is an area of continuing research.

Limitations of current vaccines against COVID-19

Most COVID-19 vaccines in use and in development are designed to elicit immune responses mediated by neutralizing antibodies against the SARS-CoV-2 spike protein. The key role of the spike protein in mediating viral entry into lung cells (through binding to the angiotensin-converting enzyme 2 [ACE2] receptor and subsequent virus-host membrane fusion) underpins its selection as the main target protein in COVID-19 vaccines. Several of the COVID-19 vaccines currently authorized for use work by instructing our own cells to make copies of the virus spike protein, which are recognized as being foreign by our immune systems. This triggers the production of antibodies against the virus that can prevent it from infecting host cells upon a subsequent infection.
People who are fully vaccinated against COVID-19 are highly protected against severe infection, hospitalization and death. However, breakthrough cases in vaccinated individuals have been reported and may account for the high numbers of infections recently recorded in Israel, a country that was successful in rapid roll out of COVID-19 vaccination and has achieved high coverage levels.1 These trends may reflect a possible waning in vaccine-induced immunity over time, which may call for the requirement for booster vaccinations. It is also possible that the apparent decline in vaccine effectiveness is due to the circulation of SARS-CoV-2 variants that, as a result of ongoing viral evolution, have acquired mutations in the spike protein that allow for the evasion of vaccine-induced immunity.

What’s next for COVID-19 vaccine development?

Given the need to control current and emerging variants of concern that can evade the immune response to available vaccines and undermine their effectiveness, efforts are in progress to develop second-generation vaccines to protect against SARS-CoV-2 variants. As well as improving the breadth of recognition of different variants of SARS-CoV-2, there may also be a rationale for developing next-generation COVID-19 vaccines that are broadly protective against related coronaviruses. SARS-CoV-2 is not the first coronavirus outbreak to impact humans, with outbreaks of severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS) also having occurred in the last two decades. The development of a ‘pan-coronavirus’ vaccine would be highly desirable to prevent or reduce the risk of future pandemics caused by related coronaviruses with potential to cause severe human diseases.

There is growing evidence that immunity against SARS-CoV-2 through current vaccines is waning.2,3 While there has been a general acceptance that it is imperative for vaccines to elicit neutralizing antibodies responses, antibody levels diminish over time and other immunologic protective mechanisms are likely to be important to induce a longer-lasting immune response more comparable with that elicited by natural infection, including T cell immunity. From experience with other coronavirus infections, T cells responses are thought to offer far more durable protection than antibody responses.4 As expected for a viral infection, CD4+ and CD8+ T cells are important mediators in the host response to SARS-CoV-2 infection, by supporting B cell function and antibody responses and by killing infected cells, respectively.

CD8+ T cells (cytotoxic T lymphocytes [CTL]) can target sequences of viral proteins that are internal to the virus (unlike antibodies that bind proteins on the surface of the virus), some of which are genetically very stable. This raises the possibility of designing vaccines against targets that are less prone to antigenic or genetic drift than spike proteins, and incorporating targets from multiple proteins into one vaccine. There may be other reasons to look beyond spike proteins in the design of next-generation vaccines when we consider insights gained from animal studies on the impact of spike protein on cellular function. Experiments using a spike protein-carrying pseudovirus show that coronavirus spike proteins can induce biological abnormalities in ACE2 receptor-expressing cell types (including blood vessel cells) and potentially cause adverse pathological events.5 Such findings, coupled with the detection of spike protein circulating in the blood of mRNA vaccine recipients,6 have raised some uncertainties on the targeting of spike protein in vaccine design. Whilst it is unknown whether the spike proteins generated by COVID-19 vaccines behave in the same manner as the wild-type spike proteins of SARS-CoV-2 and there is no firm evidence that vaccine-introduced spike proteins are harmful to humans, the findings have raised questions about the safety of spike protein-generating vaccines.

T cell priming offers a novel approach to coronavirus vaccine design

With the potential to deliver fast, broad, and long-lasting immunity, CD8+ T cell priming is a vaccination strategy that lends itself to the design of next-generation COVID-19 vaccines. Priming of naïve T cells by vaccination that are boosted to a memory phenotype upon later infection is expected to facilitate an immediate CD8+ T cell response; this is predicted to contain disease and mimic the natural course of the immune response, leading to development of long-term immunity. Furthermore, the inclusion of T cell epitopes from within conserved regions of the viral genome in such vaccines may reduce the impact of viral mutations on the vaccine-induced immune response and allow for potential protection against new variants and related viruses that share the same conserved epitopes.

T cell-priming is an approach being pursued at Emergex Vaccines for the development of vaccines against several RNA virus infections. A vaccine with the potential to offer broad and long-lasting dual protection against SARS-CoV-1 and SARS-CoV-2, current and future mutations and different variants of concern is due to enter Phase 1 trials. The candidate vaccine targets conserved epitopes from both spike and nucleocapsid parts of the virus. In challenge experiments with SARS-CoV-1, mice which received the candidate vaccine were protected from lung pathology, demonstrating strain cross-reactivity.

Find out more about the science behind T cell priming vaccines and the vaccines being developed using this approach at Emergex Vaccines by visiting www.emergexvaccines.com.

References

    • Wadman M. Israel’s grim warning: Delta can overwhelm shots. Science 2021;373:838 –839
    • Levin EG et al. Waning Immune Humoral Response to BNT162b2 Covid-19 Vaccine over 6 Months. N Engl J Med 2021 Oct 6. doi: 10.1056/NEJMoa2114583
    • Chemaitelly H et al. Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar. N Engl J Med 2021 Oct 6. doi: 10.1056/NEJMoa2114114
    • Hellerstein M. What are the roles of antibodies versus a durable, high quality T-cell response in protective immunity against SARS-CoV-2? Vaccine X 2020;6:100076
    • Lei Y et al. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circ Res 2021;128:1323–1326
    • Ogata AF et al. Circulating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients. Clin Infect Dis 2021 May 20;ciab465. doi: 10.1093/cid/ciab465

Nature paper provides further evidence of the benefits of eliciting a T-Cell response for COVID-19

Abingdon, Oxon, UK, 11 November 2021 – Emergex Vaccines Holding Limited (‘Emergex’, or ‘the Company’), a company tackling major global infectious disease threats through the development of 100% synthetic T Cell priming vaccines was pleased to read an interesting Nature paper published online yesterday, highlighting the role of T-Cells in some COVID-19 patients, providing rapid clearance of SARS-CoV-2 and strong and long lasting immunological memory. The paper also received coverage in articles in The Guardian and The Times newspapers today.

These data provide evidence to support our approach to vaccine development. Our next generation vaccines are designed to deliver broad and long lasting immunity by triggering the body’s T-Cell response. T-Cell vaccine technology offers the potential for long-lasting immunity that does not require seasonal boosting and may be better suited to rapidly mutating viruses than where new variants are generated and antibodies may become less effective.

– Ends –

For further information, please contact:

Emergex

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

Consilium Strategic Communications
Chris Gardner / Ashley Tapp / Aaron Kelly
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 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.

Can One Vaccine Provide Immune Protection Against Multiple Pathogens?

Can One Vaccine Provide Immune Protection Against Multiple Pathogens?

The idea of one vaccine offering a wide range of protection against multiple pathogens or strains is an attractive concept – it would reduce the demands on healthcare systems to deliver vaccination programmes, provide improved uptake of vaccines and reduce the burden for patients who may not have easy access to vaccination centres around the world. The MMR (Measles, Mumps and Rubella) vaccination is an effective example but in reality, the vaccine contains three live, attenuated viruses, delivered in one dose. Can a single vaccine offer protection against multiple pathogens?
When we think of the latest vaccines, such as SARS-CoV-2 vaccines, they fall into two categories, mRNA vaccines and viral vector-based vaccines. Both types of vaccines are designed to generate specific antibodies against the spike protein of the SARS-CoV-2 virus. A CD4 Helper T-Cell component may exist for these vaccines1 (in this case, only the spike protein region of the virus). This contrasts with a natural infection, in which a full T-Cell response, both CD4 Helper and CD8 Cytotoxic, is generated to the entire virus.
Antibody-generating vaccines appear to be effective against the SARS-CoV-2 virus in its current form, albeit potentially subject to reduced efficacy as the virus mutates at the spike region – the target of the vaccine-induced neutralizing antibodies.
RNA viruses, such as SARS-CoV-2 exist as a cloud of genetically different virions, mutating rapidly with the selection of dominant strains of the virus being driven by transmission advantages (if a new mutation requires fewer virions to infect an individual, that strain is likely to have an advantage) as well as response to immunologic pressure. Viral mutation is a feature of RNA viruses and effective vaccination requires the ability to provide broad, mutation-agnostic protection to a population that lasts for extended periods of time.
The Coronavirus family is a large group of RNA viruses, all with the characteristic crown-like spikes on their surfaces. The spike protein (the target of the currently licensed SARS-CoV-2 vaccines) is different for each type of Coronavirus, which is why antibodies generated in response to a SARS-CoV-2 vaccination are unlikely to offer immune protection against other members of the coronavirus family such as MERS-CoV (Middle East Respiratory Syndrome causing virus) or SARS-CoV-1 (Severe Acute Respiratory Syndrome causing virus). With an antibody generating vaccine, cross-reactive immunity is highly unlikely.

Why can’t we vaccinate against the common cold?

The common cold can be caused by a wide range of viruses, including Rhinoviruses, Picornaviruses, Coronaviruses and Adenoviruses, among others. In turn, each of these viruses have multiple serotypes, meaning hundreds of different possible viral sequences which the immune system must learn to recognise. Antibody generating vaccine technology would require identifying an epitope (antibody binding site) that is common to the majority of serotypes – however, this is extremely challenging as each serotype differs in its structure, and therefore any changes at the antibody binding site will prevent effective antibody binding, and prevent the vaccine working effectively.
The idea of one vaccine offering protection for multiple pathogens goes back to the very start of vaccination – when Edward Jenner, in 1796, first documented patients previously exposed to Cowpox appeared to have immune protection from Smallpox – the concept of cross-reactive immunity was born. What Jenner had actually discovered was that the natural immune response to Cowpox also recognised similar peptide ‘markers’ expressed on infected cells for both viruses – thereby allowing the T-Cells from a previous Cowpox infection to rapidly respond to a new and potentially more deadly Smallpox infection. Immune memory to Smallpox or Cowpox infection is extremely long-lived, antiviral CD8 T-cell memory has been demonstrated for up to 83 years after Smallpox infection2.
We are seeing emerging evidence of cross-reactive immunity based upon natural infection in the current pandemic. While the ongoing COVID-19 outbreak rapidly overwhelmed medical facilities of particularly Europe and North America, accounting for 78% of overall global deaths attributable to the COVID-19 pandemic, only 8% of deaths have occurred in Asia where the outbreak originated. Interestingly, Asia and the Middle East have previously experienced multiple rounds of Coronavirus infections, perhaps suggesting build-up of acquired immunity to the causative SARS-CoV-2 that underlies COVID-193.
The reason for this ‘cross reactive’ immunity’ is thought to be due to the T-Cell response. T-Cells do not directly interact with viruses in the body. Instead, in their naïve form, they are ‘primed’ by antigen presenting cells (APCs) which present thousands of peptides from all parts of the viral structure to the naïve T-Cells, and so activating the T-Cells to seek cells infected by the viruses who express these foreign peptides on their surface in response to infection.
This idea is the subject of ongoing research and offers the potential to create vaccines that are constructed using ‘conserved’ peptides that may be common to multiple pathogens from the same family. This can potentially be achieved by using peptide sequences from conserved, internal viral regions of the viral genome. These regions are often critical to the life cycle of the virus and therefore cannot mutate significantly without making the virus obsolete. This is the concept of the T-Cell Priming vaccines.
The idea of ‘priming’ naïve CD8+ T-Cells with a set of peptide ‘signals’ that are both conserved and common to multiple viruses from the same family is an exciting area of research and offers the hope of one vaccine against multiple diseases in the future, and vaccines that are less likely to be impacted by viral mutation than antibody-generating vaccines.
Whilst there is no current vaccine that offers the dual protection from SARS-CoV-1 and SARS-CoV-2, there are T-Cell vaccines in development that have shown this cross-reactive protection in murine models and are entering Phase I clinical trials in 2021.
To find out more about T-Cell priming vaccines and the research that we are conducting at Emergex, please visit our website www.emergexvaccines.com or email us at info@emergexvaccines.com.

T-cell priming vaccines offer the potential to provide faster, broader and longer lasting immunity to reduce serious illness associated with infectious diseases such as COVID-19. Here’s why…

T-cell priming vaccines offer the potential to provide faster, broader and longer lasting immunity to reduce serious illness associated with infectious diseases such as COVID-19. Here’s why…

The human immune system has evolved over millennia and includes a multitude of different immune effector cells, antibodies and signalling molecules. As our knowledge of this complex system grows, new scientific insights may provide clues on how to develop new and more effective vaccines.
This is particularly relevant and timely as SARS-CoV-2 variants emerge and spread globally, causing further outbreaks of COVID-19 around the world.

The need for innovation to develop new vaccines

At a basic level, the aim of a vaccine is to prepare the body to have the capacity to turn a dangerous pathogen into a mild irritant and reduce the chance of onward transmission. RNA viruses, like SARS-CoV-2, exist as viral quasispecies or mutant clouds – populations of large numbers of variant genomes subject to constant change due to replication errors, so viral mutation and new dominant variants are inevitable.
Antibody generating vaccines have helped reduce the severity of COVID-19 disease but may offer more limited protection from new viral variants1, for which viral variant booster vaccines may be required in the future. There is an acute need for innovation to explore new vaccines that provide broader, mutation agnostic and longer-lasting immunity. In addition, we need vaccines that are easy to store and administer, reducing the demands on our healthcare systems.

Antibody generating vaccines

Antibodies are large Y shaped protein molecules produced by the B lymphocyte cells of the immune system and which circulate in the blood and bind to ‘foreign objects’, including pathogens such as viruses. Antibody-generating vaccines are well established and operate through the production of viral-specific antibodies. These attach to specific parts of the viral structure (such as Spike protein in SARS-CoV-2) allowing extracellular virions to be cleared from the body by other cells in the immune system.
However, viruses mutate at many points especially surface proteins; if this includes the antibody target it may reduce the efficacy of the vaccine. It is important to note that viruses replicate using the host cells apparatus and once inside a cell, are ‘hidden’ from circulating antibodies.

The case for T-cell priming vaccines

T-cells are a type of white blood cell, and one of the most important roles they serve in the immune system is identifying and killing viral infected cells from the body, preventing viral replication. Infected cells express ‘marker’ peptides on their surface, some of which will come from the infecting virus and many of which will be highly conserved (unlikely to be subject to mutation) and unique to families of viruses. ‘Priming’ naïve T-cells (naturally occurring CD8+ T Lymphocytes) prepares the body to recognize these markers of cellular infection and the body creates virus specific T-cells in readiness for subsequent exposure to that pathogen. Once ‘primed’, a subsequent exposure to the virus is rapidly met by an ‘army’ of virus specific cytotoxic T-cells, which can kill infected cells before they can produce active viruses through replication – thus an infection is never allowed to take hold.
A T-cell response targets the infected cells (the ‘virus factories’) and not the virus itself using a large number of ‘marker’ peptides derived from many parts of the viral structure– so mutations of the virus are less likely to lead to a loss of efficacy as the cellular markers of infection are often highly conserved peptides from the virus.
T-cell priming vaccines still allow the body to undergo its natural immune response to a subsequent infection (for example, the creation of neutralizing antibodies), however this will not be driven by high levels of live, replicating viruses as the T-cell response will be immediate and viral replication is likely to be halted before an active infection can take hold. T-cell based immunity has been shown to last for decades and so T-cell priming vaccines offer the hope for a much broader and longer lasting immune response2.
Emergex is developing next-generation T-cell priming vaccines to tackle major global diseases. T-cell priming vaccines offer potential efficacy against a range of viral pathogens including Coronavirus, Dengue, Influenza, Zika, Yellow fever, as well as intracellular bacteria. Find out more about our approach at www.emergexvaccines.com.

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.”

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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.

Emergex Strengthens Senior Management Team

Appointments of Mr Robin Cohen as Business Development Director and Ms Susi Osborne as Manufacturing Director

Abingdon, Oxon, UK, 23 February 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, today announces the appointment of Mr Robin Cohen, as Business Development Director. The Company is also pleased to announce the appointment of Ms Susi Osborne as Manufacturing Director, who joined Emergex in January this year.

Today’s announcement follows the recent collaboration and development agreement with the Immunobiological Technology Institute (Bio-Manguinhos) of the Oswaldo Cruz Foundation (Fiocruz) in Brazil to develop a COVID-19 vaccine using Emergex’s next generation synthetic T-Cell vaccine technology. These appointments will support this and future collaborations, providing additional business development, commercial and manufacturing expertise to advance the Company’s pipeline of vaccine candidates.

Mr Cohen joins Emergex from Janssen-Cilag, a subsidiary of Johnson & Johnson, where, since 2017, he was working as part of the EMEA regional Business Development Team and also responsible for Business Development in the UK pharmaceutical business. He focussed on creating partnerships and strategic alliances to bring new assets into the organisation and enhance the capabilities of existing franchises. Prior to this role, Mr Cohen was the Commercial Lead for Infectious Diseases where he  was responsible for the launch of a number of new therapeutic treatments in the fields of Hepatitis C and HIV. Prior to this, he was successful in a number of senior leadership roles in both Sales and Marketing fields across multiple therapy areas.

Ms Osborne has a wealth of manufacturing knowledge, with over 25 years of experience within the biotechnology and pharmaceutical industries. She joins Emergex from ADC Biotechnology, which focuses on the development of antibody drug conjugates, where she was the Head of Manufacturing Operations since 2018. During her time in ADC Biotechnology, she played a crucial role in the development, design and build of a new GMP manufacturing site. Prior to ADC Biotechnology, Ms Osborne held senior positions at Ipsen, GSK and Novartis, overseeing key operational and manufacturing roles in addition to providing regulatory affairs advice. At Ipsen, Ms Osborne played a key role in the new facility build of a GMP manufacturing facility and the tech transfer of a product from a CMO. The facility was successfully licenced by the FDA in 2008.

Storme Moore-Thornicroft, co-founder and COO of Emergex commented: “We are delighted to have filled these two important roles as we look to accelerate development of our promising pipeline of novel, synthetic vaccine candidates. Robin is well placed to oversee discussions with current and potential partners interested in our vaccine programmes. The appointment of Susie Osborne as Manufacturing Director is timely and reflects the progress we are making with our vaccines and the need to ensure swift manufacturing capability is firmly in place to meet clinical trial demand.”

Robin Cohen, Business Development Director, commented: “Emergex is at the cutting edge of vaccine development and I am excited to be coming on board at a key time in the Company’s development. There is a pressing need globally for effective vaccines that are easy to administer, manufacture and store, criteria which Emergex’s technology is designed to meet. I am looking forward to working with the team at Emergex to advance vaccine candidates with the potential to prevent some of the world’s most deadly infectious diseases.”

Susi Osborne, Manufacturing Director, commented: “ The current pandemic has seen huge scientific advances in vaccine development. However, vaccine development is not without its challenges including how we manufacture such vaccines and protect against variants of the virus. Emergex is well placed to address many of these issues, its vaccines are both easy to manufacture and could deliver greater protection for longer against more variants. I welcome the opportunity to be part of the Emergex team, bringing to bear my extensive manufacturing experience as we look to expand our vaccine manufacturing capabilities and develop candidates that can meaningfully address current and future pandemics.”

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For further information, please contact:

At the Company
Emergex
Storme Moore-Thornicroft, Executive Director
Phone: +44 (0)1235 527589
Email: smt@emergexvaccines.com
Consilium Strategic Communications
Chris Gardner / Sue Stuart / 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.

Emergex Notes U.S. Government Reports Highlighting the Importance of T-Cell Immunity in Controlling Viral Infections

Emergex Notes U.S. Government Reports Highlighting the Importance of T-Cell Immunity in Controlling Viral Infections

  • U.S. federal appropriations reports encourage support for T-Cell vaccine approaches for pandemic influenza during the 2021 fiscal year

Abingdon, Oxon, UK, 28 January 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, notes language directed at the U.S. Department of Health and Human Services (HHS) included as part of the Fiscal Year 2021 appropriations measures in the U.S. House and Senate, which highlights the importance of T-Cell immunity in addressing pandemic influenza (flu).

The House Labor, HHS, Education and Related Agencies (Labor/HHS) Appropriations report, H. Rpt. 116-450, and Senate language issued along with a draft Senate Labor/HHS bill, encourage the Department of Health and Human Services to prioritize research, development, and manufacturing of T-Cell vaccine approaches to address pandemic flu, further recognizing the need to advance research in this field.

Professor Thomas Rademacher, CEO and co-founder of Emergex, commented:Emergex has been investigating and building on the importance of T-Cell mediated immunity and looks forward to continuing research efforts in this promising area. We are encouraged by the recognition of the importance of a robust T-Cell immune response and its role in disease prevention. We view the appropriations language as supportive of our efforts as well as others who are advancing the field of T-Cell immunology. The new generation of vaccines will be focusing on the induction of proper T-Cell immunity and CD8+ T-Cell responses.

Emergex Vaccines is currently developing a 100% synthetic and universal (seasonal and pandemic) influenza T-Cell vaccine, which is suited as an on-demand line of defense against a potential influenza pandemic, as well as protection against seasonal influenza strains. For decades, the focus of prophylactic vaccines was to elicit neutralizing antibodies, but it has become increasingly evident that T-Cell-mediated immunity plays a central role in obtaining a durable immune response. Growing evidence suggests that neutralizing antibodies fail to provide the desired long-term efficacy and protection against several viral infections, including influenza.

The House and Senate appropriations language was finalized on December 27, 2020, when President Trump signed into law The Coronavirus Response and Relief Supplemental Appropriations Act of 2021, H.R. 133, a legislative package that combines $1.4 trillion in annual government funding and $900 billion in coronavirus relief measures.

The Senate language states:

T Cell-mediated Immunity.—T cell-mediated immunity plays a central role in controlling viral infections. To create a universal influenza vaccine, it is necessary that HHS prioritize research, development, and rapid manufacturing technologies that enable application of T cell vaccines as a complementary yet alternative approach to the use of vaccines containing live attenuated or killed micro-organisms.

The House language, included under the National Institute of Allergy and Infectious Diseases (NIAID), within the National Institutes of Health (NIH), states:

Pandemic Influenza.—T cell-mediated immunity plays a central role in controlling viral infections. To create a universal influenza vaccine, the Committee encourages NIAID to prioritize research to facilitate the application of vaccines that induce strong cross-reactive T cell responses as a complementary or alternative approach to vaccines primarily designed to elicit an antibody response.

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