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.

Visit our LinkedIn page or Twitter account for live updates.

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

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