Emergex Reports Promising Data from Completed Swiss Phase I Trial of CoronaTcP™, T Cell-Priming Immune Set-Point Candidate for Betacoronaviruses

  • – First-in-human intradermal administration of CoronaTcP™ was generally well-tolerated
    – Evidence for generation of virus-specific effector and memory CD8+ T cells
    – Data reinforce findings from trial of DengueTcP, Emergex’s product candidate for Dengue, further supporting the company’s T cell-based approach to protection against RNA viruses

ABINGDON, United Kingdom, 19 July 2023 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’) a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates, today announced the successful completion of naNO-COVID, a Phase I clinical trial in Switzerland investigating the safety and reactogenicity of CoronaTcP™[1]  in healthy volunteers. CoronaTcP is Emergex’s multi-target T cell-priming set-point product, designed to be broadly effective against disease caused by Betacoronaviruses, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2, which pose significant epidemic or pandemic risk.

Assessment of primary outcome measures of the trial indicate that CoronaTcP showed a favourable safety profile, with no treatment-related serious adverse events observed. The majority (88%) of adverse events were mild, with the most common being injection-site pain. There was no systematic difference between groups that received high or low dose CoronaTcP, in terms of overall safety or reactogenicity.

In secondary immunogenicity analyses, the assessment of baseline levels of SARS-CoV-2-specific anti-nucleoprotein antibodies indicated most participants had experienced previous SARS-CoV-2 infection. A number of participants seroconverted during the trial (as a consequence of exposure to SARS-CoV-2) but had mild symptoms, confirming that CoronaTcP does not worsen an acute episode of COVID-19. Cellular analyses demonstrated that CoronaTcP (two doses administered at Day 0 and 21) was able to activate virus-specific CD8+ T cells, with a significant increase in frequencies of CoronaTcP-specific CD8+ CD137+ CD69+ cells following in vitro antigenic stimulation in both low and high dose CoronaTcP groups at Day 35 post-treatment. Significant changes were also observed for several virus-specific CD8+ memory subsets. Further studies with a larger number of participants are warranted for full assessment of T cell responses, including whether they are the consequence of a prime or a boost, and their correlation with protection.

Overall findings from the first-in-human clinical trials of Emergex’s T cell-priming immune set-point candidates against Dengue and Betacoronavirus diseases (naNO-DENGUE and naNO-COVID, respectively) have demonstrated a favorable safety profile. Immunogenicity assessments provide an initial proof of concept that products developed from Emergex’s therapeutic platform can successfully induce virus-specific T cell responses. Such results favour the further development of the Dengue and Betacoronavirus candidates in larger clinical trials. Overall, Phase I trial data validate Emergex’s T cell-based approach to protection against RNA viruses and confirm the platform’s potential using this innovative technology, supporting investigation of other T cell-priming immune set-point candidates from the same platform.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, said: “The positive data from both clinical trials – naNO-DENGUE and naNO-COVID – represent an important landmark for Emergex. Demonstrating that our platform has an acceptable safety profile and successfully mobilises specific T cells that may elicit broad and long-term immune memory, validates our approach. By improving T cell-based immunity, we can enhance any previous immune status. We are delighted that this first assessment of a treatment against infectious diseases for clinical use, based solely on a T cell response, was successful.”

The naNO-COVID Trial

The naNO-COVID trial (NCT05113862) was a Phase I double-blind, randomized, base particle-controlled, single centre study designed to evaluate the safety and reactogenicity of two intradermal injections of an anti-Betacoronavirus candidate, CoronaTcP, at two different dosages. Conducted at the clinical investigation unit of the CHUV (Centre Hospitalier Universitaire Vaudois)-UNIL (University of Lausanne) in Switzerland, the study enrolled 26 healthy adult volunteers previously vaccinated against SARS-CoV-2. Participants were randomized to receive one of the following treatments: low-dose CoronaTcP (n=10), high-dose CoronaTcP (n=10), low-dose base nanoparticle comparator (n=3), or high-dose base nanoparticle comparator (n=3) (low and high-dose CoronaTcP being 2.5 nmol or 7.5 nmol total peptide, respectively, and the comparator being the construct base particle without peptides but with equivalent gold content). Each participant received an intradermal injection of the assigned treatment on Day 0 and on Day 21 using a microneedle device and was followed up for six months.

naNO-COVID was the second stage of a two-stage clinical trial of Emergex’s T cell priming platform technology, initiated upon the favourable outcome of an interim analysis of safety data from the first stage, naNO-DENGUE.

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA. The company is pioneering the development of 100% synthetic, T cell-priming immune set-point therapeutic candidates that harness and direct the body’s natural T cell immune response to destroy and to clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to provide protection against some of the world’s most urgent health threats. Emergex’s first indications being pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronavirus, Dengue Fever and Universal Influenza A (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. In the near future, other disease applications will follow.

Find out more online at www.emergexvaccines.com.

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

 Rachelle Babb

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

Visit our LinkedIn page or Twitter account for updates

[1] Trademark application submitted

Emergex Appoints Sir Michael Rake as Board Chairman

  • Highly experienced international Board Leader joins Emergex as the company grows and progresses clinical development of its pipeline of T cell-priming immune set-point candidates

Abingdon, Oxon, UK, 29 June 2023 – Emergex Vaccines Holding Limited (‘Emergex’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates, today announced the appointment of Sir Michael Rake as Chairman of the Board. Sir Michael takes on this role from Finian Tan, Ph.D., who becomes Emergex’s Deputy Chairman.

Sir Michael has had a long and distinguished career in international business as a Senior Executive and Board leader over several decades. He is currently the Chairman of Great Ormond Street Hospital, the international centre of excellence in child healthcare; a position which he has held since 2017. He is also the Chairman of Wireless Logic Ltd, Newday Ltd, and Majid Al Futaim Holdings llc in the UAE and a Vice President of the UK charity The Royal National Institute of Blind People (RNIB). He is a Senior Advisor to Elliott Advisors and is a Director of Trust Payments Ltd.

During his career, Sir Michael has held the role of Chairman at many international blue-chip companies in numerous industry sectors, including: BT Group Plc (2007-2017); Worldpay Group Plc (2015 – 2017); EasyJet plc (2010 – 2013); KPMG, UK Chair (1998-2007). becoming Global Chair (2002-2007); and Deputy Chairman at Barclays Bank plc (2008 – 2015). He has also served as a Director at S&P Global (2007-2018), the UK Financial Reporting Council (2008-2011) and was the Lead Director of Worldpay Inc. (now FIS).

Sir Michael has additionally held many advisory roles during his career, including Senior Advisor to Citibank, Senior Advisor to the International Affairs Think Tank Chatham House, a member of the Oxford University Global Board for Business Reputation, and a William Pitt Fellow at Pembroke College, Cambridge. Sir Michael was also the President of the Confederation of British Industry (CBI), a member of former UK Prime Minister David Cameron’s Business Advisory Council and Chairman of the UK International Chamber of Commerce. In addition, he was a member of Former UK Prime Minister Gordon Brown’s National Security Forum, the first Chairman of the Commission for Employment and Skills and the first Chairman of the Private Equity Oversight Group Guidelines Monitoring Committee.

Sir Michael qualified as a chartered accountant in the UK in 1972 and became a partner with Peat Marwick (KPMG) continental firm in Brussels in 1979, subsequently becoming Senior Partner of Peat Marwick (KPMG) Middle East in 1986, before becoming Chair of the UK firm in 1998,the European firm in 1999, and Global firm in 2002.

Sir Michael was knighted by the late HRH Queen Elizabeth II in 2007 for his extensive service. In 2011, he received the British American Business UK Transatlantic Business Award and in 2013, he received the Channing Award for corporate citizenship, was voted the FTSE 100 non-executive Director of the year and received the ICAEW outstanding achievement award. Most recently, in 2021, he was made a Grand Cordon of the Order of Rising Sun, by the Emperor of Japan, for services to UK/Japan relations.

Sir Michael Rake, the new Chairman at Emergex, commented: “I look forward to joining the Emergex Board as Chairman and sharing my experience and network to help grow the business at such a pivotal time in the company’s evolution. Following the COVID-19 pandemic and its far-reaching global impact, there remains a vital need for innovative and durable therapies to tackle the continuing threat of COVID-19 and other, emerging infectious diseases. Emergex’s proprietary technologies and expansive pipeline of T cell-priming immune set-point candidates are well-placed to offer a valuable solution, with potential to offer long-term protection against infectious health threats to diverse and global communities.”

Dr Finian Tan, the former Chairman and new Deputy Chairman at Emergex, added: “Sir Michael has had a long and distinguished career to-date and will bring his global expertise to the Board, as well as an impressive body of international business contacts. I look forward to working closely with him to maximise and steward the opportunities available for Emergex at this exciting time of continued growth and development.”

 

– Ends –

  • For further information, please contact:
  • Emergex Media Inquiries
    Storme Moore-Thornicroft, Executive Director

    Phone: +44 (0) 1235 527589

    Email: smt@emergexvaccines.com

     

    		 Rachelle Babb

    Phone: +1 (929) 325-7559

    Email: rachelle.babb@russopartnersllc.com

     

     

    About Emergex
    Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA. The company is pioneering the development of 100% synthetic, T cell-priming immune set-point therapeutic candidates that harness and direct the body’s natural T cell immune response to destroy and to clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to provide protection against some of the world’s most urgent health threats. Emergex’ first indications being pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronavirus, Dengue Fever and Universal Influenza A, including pandemic influenza, as well as [ii] intra-cellular bacterial infectious disease, such as Francisella tularensis. In the near future, other disease applications will follow.
    Find out more online at www.emergexvaccines.com.

    Visit our LinkedIn page or Twitter account for 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 and Brazil’s IBMP Announce Clinical Development Collaboration for T Cell-Priming Immune Set-Point Candidates

  • Emergex and Brazil’s IBMP to co-fund Phase II and Phase III studies of Emergex’s Dengue Fever and Betacoronavirus T cell-priming immune set-point therapeutic candidates in Brazil, with potential to expand to additional indications
  • IBMP has made an equity investment in Emergex, contributing to the funding of Phase II clinical trials

Abingdon, Oxon, UK, 20 June 2023 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates, today announced a multi-level collaboration agreement with the Molecular Biology Institute of Paraná (IBMP) in Brazil.

IBMP is a commercial organization embedded within Fiocruz, the Brazilian national institution for research and production of biopharmaceuticals and vaccines, linked to the Ministry of Health. Fiocruz has a strong commercial track record in the healthcare space, with expertise in the development, manufacturing, regulatory approval, and commercialization of medicines and medical diagnostics in Brazil.

Emergex and IBMP have agreed to co-fund Phase II and Phase III studies in Brazil of Emergex’s T cell-priming set-point candidates for Dengue Fever and Betacoronavirus, known respectively as DengueTcPTM (trademark application submitted) and CoronaTcP TM (trademark application submitted). Both clinical trial product candidates have successfully completed Phase I+ clinical trials in Switzerland and are nearing submission and evaluation by ANVISA, the Brazilian health regulatory agency.

Per the terms of this agreement, Emergex will conduct clinical-stage manufacturing of the products with the planned transition to IBMP for commercial scale manufacturing in the region. IBMP will obtain exclusive marketing and commercialization rights of the two candidate products in Brazil and South America. A Joint Steering Committee with representatives from both Emergex and IBMP will oversee the collaboration and commercialization of the select immunotherapies.

The agreement also allows for future expansion into additional indications. This arrangement potentially encompasses shared development and commercialization of Emergex’s T cell-priming set-point candidates targeting Chikungunya, for which development is underway, Influenza A (including pandemic strains), for which Emergex has advanced to cGMP manufacturing and is ready to initiate Phase I clinical trials in the U.S., and Yellow Fever. At the end of 2022, Emergex announced the generation of a Chikungunya ligandome, which is expected to progress into Phase I human trials in 1Q24.

IBMP has also made an early equity investment into Emergex, which has potential for future expansion pending the completion of its ongoing due diligence process. Additionally, IBMP will fund Emergex’s share of the costs for Phase II trials in Brazil for Dengue, Betacoronavirus and Universal Influenza A in return for additional equity, subject to shareholder approval.

Professor Thomas Rademacher, Co-founder, and CEO at Emergex, commented: “Following the successful Phase I trials for our Dengue Fever and Coronavirus candidates in Switzerland we look forward to progressing into a Phase II trial in Brazil, where Dengue is endemic. We have been working closely with the team at IBMP for several years, so it is wonderful to formalize our relationships with this agreement.”

Pedro Ribeiro Barbosa, CEO at the Molecular Biology Institute of Paraná (IBMP) in Brazil, added: “My team and I look forward to initiating this important international collaboration and progressing the Emergex Dengue candidate into Phase II. Dengue presents a serious disease burden in Brazil with hundreds of thousands of cases across the country each year and hundreds of deaths, so there is urgent need for new therapies.”

 

– Ends –

  • For further information, please contact:
  • Emergex Media Inquiries
    Storme Moore-Thornicroft, Executive Director

    Phone: +44 (0) 1235 527589

    Email: smt@emergexvaccines.com

     

    		 Rachelle Babb

    Phone: +1 (929) 325-7559

    Email: rachelle.babb@russopartnersllc.com

     

     

    About Emergex
    Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA. The company is pioneering the development of 100% synthetic, T cell-priming immune set-point therapeutic candidates that harness and direct the body’s natural T cell immune response to destroy and to clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to provide protection against some of the world’s most urgent health threats. Emergex’ first indications being pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronavirus, Dengue Fever and Universal Influenza A, including pandemic influenza, as well as [ii] intra-cellular bacterial infectious disease, such as Francisella tularensis. In the near future, other disease applications will follow.
    Find out more online at www.emergexvaccines.com.

    Visit our LinkedIn page or Twitter account for 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 Announces Positive Phase I Trial Data for DengueTcP™, Its Novel T Cell-Priming Immune Set-Point Candidate

  • naNO-DENGUE trial results demonstrate that DengueTcP is well-tolerated with no treatment-related serious adverse events
  • Immunogenicity data shows peptide antigen-specific effector and memory CD8+ T cells were elicited
  • Clinical proof-of-concept demonstration for Emergex’s therapeutic platform, supporting further development

Abingdon, Oxon, UK, 6 June 2023 – Emergex Vaccines Holding Limited (‘Emergex’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates, today announced positive outcomes from its first-in-human clinical trial of DengueTcP (trademark application submitted), a candidate against Dengue virus, the causative agent for Dengue Fever.

The primary objective of the naNO-DENGUE trial was to evaluate the safety, tolerability and reactogenicity of two different doses (2.5 and 7.5 nmol total peptide) of DengueTcP administered by intradermal microneedle injection to healthy volunteers. Both dose levels of DengueTcP appeared to be safe and well tolerated. No treatment-related serious adverse events were reported, and the majority of adverse events were mild and transient. From a safety perspective, both doses were considered acceptable for use in further trials.

The assessment of immunogenicity produced the following findings:

  • Statistically significant increases of virus-specific effector (CD137+CD69+) CD8+ T cells and memory CD8+ T cells were observed post-immunisation.
  • Notably, the elevated T cells included CXCR3+ central memory and differentiated effector memory cells. These T cell subsets are of particular relevance given their roles in locating virus-infected cells in the skin and in providing protective immunity to Dengue infection.2,3
  • DengueTcP did not induce anti-DENV antibodies, a favourable outcome that reduces the risk of antibody-dependent enhancement (ADE) of the disease that has been observed by others in trials of traditional vaccines.
  • Taken together, preliminary results indicate that treatment with DengueTcP generates memory T cells in peripheral blood that have the capability to home to tissues infected by that incoming virus.

Overall, the clinical results provide proof-of-concept that Emergex’s therapeutic platform can successfully induce virus-specific CD8+ T cell responses. Data from the trial support further development of Emergex’s platform, which has the potential to provide cross-reactive immunity to a range of existing or emerging viral and intracellular pathogens.

Dr. Ramila Philip, Chief Scientific Officer, Immunotope Inc, commented: “Up to 400 million people around the world are infected with Dengue Fever each year. However, with no approved antiviral treatments and with current vaccine strategies being potentially associated with ADE related safety concerns, there is an unmet and urgent need for novel, effective solutions. It gives me an immense satisfaction to see the realization and clinical proof of our T cell based protection. Emergex’s T cell-priming immune set-point vaccine, which delivers synthetic peptide antigens based on naturally processed and presented epitope candidates, should provide broad and long-lasting immunity against all Dengue virus serotypes and potentially against other Flaviviridae strains; thus, protecting people from illness associated with these lethal tropical disease.”

Dr Athanasios Papadopoulos, Chief Medical Officer, Emergex, said: “These positive study data represent an important landmark for both Emergex and people around the world living with the risk of Dengue. These data demonstrate that our product platform has an acceptable safety profile and successfully mobilises viral-specific CD8+ T cells, which may elicit broad and long-term immune memory. The findings validate our approach and may change the way that people view immune responses post-treatment.

“Showing that we can increase the T cell-based immunity without affecting the antibodies means that we can improve any previous immune status of a person. This trial is the first time that a regulator has approved an assessment of a T cell-priming set-point candidate against infectious diseases for clinical use based solely on a T cell response; thus, we are delighted that the trial was successful.”

The naNO-DENGUE Trial
naNO-DENGUE (ClinicalTrials.gov NCT04935801) was a Phase I randomized, double-blind, vehicle-controlled, dose-finding, safety study of a synthetic nanoparticle-based, T cell-priming peptide antigen immune set-point against Dengue virus in healthy adults. A total of 26 healthy individuals aged 18-45 years recruited at the Centre for Primary Care and Public Health, Lausanne, Switzerland, were randomly assigned to receive the T cell-priming immune set-point candidate Dengue TcP or a comparator (nanocluster without peptide antigens, vehicle-nanocluster). Follow-up of trial participants took place over a six-month period following first injection.

About DengueTcP
DengueTcP, Emergex’s immune set-point product to treat dengue, is designed to elicit a specific CD8+ T cell immune response without affecting the humoral response. The drug product is composed of synthetic T cell-selective multivalent (serotypes 1 to 4) Dengue virus peptide antigens carried on ultrasmall carbohydrate-passivated nanoclusters.

Immunotope Inc. developed an immunoproteomics approach to identify the peptide antigens presented by major histocompatibility complex Class I (MHC-I) molecules on the surface of Dengue-infected cells, representing the real-world targets of the CD8+ T cell response to natural infection.4,5 Nine peptide antigens from this expression library were then selected for inclusion in the DengueTcP drug product, notably on their ability to elicit a cross-reactive immune response against all four different Dengue virus serotypes and also against other Flaviviruses.

These viral peptide antigens are anchored with specific carbohydrates to a nanocluster core. Use of a self-assembling, nanocluster-based delivery system is intended to protect the peptide antigens from proteolytic degradation, which improves their delivery to antigen presenting cells and enables induction of targeted cellular immunity. Owing to targeted delivery, nanodoses of peptide antigens are expected to be sufficient to induce a satisfactory immune response.

As a low dosage is required and as a way to mimic immune cell recruitment during a natural infection by a mosquito, DengueTcP is suited to be delivered by intradermal injection. A microneedle (or dermal patch in the future) will be used to better standardize the intradermal injection.

DengueTcP and nanoclusters have been shown to be safe in preclinical in vitro studies utilising human peripheral blood mononuclear cells and in vivo animal studies. The present trial assessed the safety of the first T cell-priming immune set-point candidate designed specifically to elicit a CD8+ T cell immune response for prevention of an acute and severe manifestation of a viral infection by Dengue and other Flaviviruses. Emergex is working with governments around the world to make DengueTcP accessible to high-risk populations as a valuable option in the fight against Dengue.

  • For further information, please contact:
  • Emergex Media Inquiries
    Storme Moore-Thornicroft, Executive Director

    Phone: +44 (0) 1235 527589

    Email: smt@emergexvaccines.com

     

    		 David Melamed

    Phone: +1 (212) 845-4225

    Email: david.melamed@russopartnersllc.com

     

     

    About Emergex
    Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA. The company is pioneering the development of 100% synthetic T cell-priming immune set-point candidates that harness and direct the body’s natural T cell immune response to destroy and clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to provide protection against some of the world’s most urgent health threats. First indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronavirus, Dengue Fever and Universal Influenza A, including pandemic influenza, as well as [ii] intra-cellular bacterial infectious disease, such as Francisella tularensis. In the near future, other disease applications will follow.

     

    Find out more online at www.emergexvaccines.com.

    Visit our LinkedIn page or Twitter account for updates.

     

    References

     

    1. Rivino L, Kumaran EA, Thein TL, et al. Virus-specific T lymphocytes home to the skin during natural dengue infection. Sci Transl Med. 2015;7(278).
    2. Graham N, Eisenhauer P, Diehl SA, et al. Rapid Induction and Maintenance of Virus-Specific CD8(+) TEMRA and CD4(+) TEM Cells Following Protective Vaccination Against Dengue Virus Challenge in Humans. Front Immunol. 2020;11:479.
    3. Hickman HD, Reynoso GV, Ngudiankama BF, et al. CXCR3 chemokine receptor enables local CD8(+) T cell migration for the destruction of virus-infected cells. Immunity. 2015;42(3):524-537.
    4. Comber JD, Karabudak A, Huang X, Piazza PA, Marques ET, Philip R. Dengue virus specific dual HLA binding T cell epitopes induce CD8+ T cell responses in seropositive individuals. Hum Vaccin Immunother. 2014;10(12):3531-3543.
    5. Testa JS, Shetty V, Sinnathamby G, et al. Conserved MHC class I-presented dengue virus epitopes identified by immunoproteomics analysis are targets for cross-serotype reactive T-cell response. J Infect Dis. 2012;205(4):647-655.

 

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

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

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

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

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

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

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

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

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

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

References

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

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

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

– Ends –

 

For further information, please contact: 

 
Emergex   Consilium Strategic Communications  
Storme Moore-Thornicroft, Executive Director 

Phone: +44 (0) 1235 527589 

Email: smt@emergexvaccines.com 

  

 Chris Gardner / Ashley Tapp  

Phone: +44 (0)20 3709 5700 

Email: Emergex@consilium-comms.com 

 

About Emergex

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

References

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

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

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

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

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

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

7. World Health Organisation Health Topics – Smallpox

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

 

– Ends –

 

For further information, please contact: 

 
Emergex   Consilium Strategic Communications  
Storme Moore-Thornicroft, Executive Director 

Phone: +44 (0) 1235 527589 

Email: smt@emergexvaccines.com 

  

 Chris Gardner / Ashley Tapp  

Phone: +44 (0)20 3709 5700 

Email: Emergex@consilium-comms.com 

 

 

About Emergex

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

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

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

Find out more online at www.emergexvaccines.com.

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

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

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

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

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

Intradermal Delivery of Vaccines and MAP Technology

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

– Ends –

 

For further information, please contact:

 
Emergex Consilium Strategic Communications
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

 Chris Gardner / Ashley Tapp

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

About Emergex

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

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

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

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

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

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

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

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

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

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

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

– Ends –

For further information, please contact:

Emergex Consilium Strategic Communications
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Robin Cohen, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

 Chris Gardner / Ashley Tapp

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

About Emergex

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

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

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

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page or Twitter account for live updates.

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

– Ends –

For further information, please contact:

Emergex Consilium Strategic Communications
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Robin Cohen, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

 

Brian Pfister, Vice President, Emergex USA

Phone: +1 847-421-0253

Email: bp@emergexvaccines.com

 Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

About Emergex

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

 

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

 

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

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page or Twitter account for live updates.

 

 

About IBMP

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

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

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

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

 

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

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

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

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

 

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

– Ends –

 For further information, please contact:

Emergex Consilium Strategic Communications
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Robin Cohen, Chief Commercial Officer

Phone: +44 (0) 1235 527589

Email: rc@emergexvaccines.com

 

Brian Pfister, Vice President, Emergex USA

Phone: +1 847-421-0253

Email: bp@emergexvaccines.com

 

Zosano Pharma

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

 Chris Gardner / Ashley Tapp / Giulia Lasagni

Phone: +44 (0)20 3709 5700

Email: Emergex@consilium-comms.com

 

Wheelhouse Life Science Advisors (Zosano PR)

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

About Emergex

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

 

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

 

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

 

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

 

About Zosano Pharma

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

Learn more at www.zosanopharma.com.

 

Forward-Looking Statements

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