Gylden’s 2025 Strategic Priorities for Advancing Innovative and Transformative Solutions for Infectious Diseases

  • Clinical trials planned to begin patient enrollment during 2025 to evaluate Gylden’s T cell Priming (TcP) candidates against Dengue (Phase II) and betacoronaviruses (Phase I-II and Phase II) and planning for study against influenza (Phase I).
  • Versatile technology platforms support the expansion of pandemic preparedness programmes and thus allow for numerous national/regional partnering opportunities.
  • Anticipated to develop ~10 “First Responder” immune TcP candidates in preparation for Phase I clinical trials, as part of a wide-ranging pandemic preparedness strategy useful globally.

ABINGDON, United Kingdom, February 24, 2025 –  Gylden Pharma Limited (‘Gylden’ or the ‘Company’), a clinical-stage biotechnology company that is addressing major global infectious diseases through the development of prophylactic, synthetic T cell-priming nanoparticle constructs and post-infectious immunotherapy candidates, today provided a 2025 corporate outlook and strategy for advancing its proprietary solutions for infectious diseases.

“We begin 2025 having achieved substantial milestones in 2024 and anticipating major innovations in how the world approaches infectious diseases and pandemic threats,” said Professor Thomas Rademacher, MD, PhD, Co-founder, Executive Director and CEO of Gylden Pharma. “Gylden’s ‘plug-and-play’ product development platform, based on experimentally-determined viral MHC class I and class II ligandome libraries, enables the Company to rapidly deploy its proprietary target peptide sequences that constitute each separate immunotherapy for a variety of dangerous pathogens and that can be used to prime the protective immune response in individuals against entire families of circulating viruses. With our unique nanoparticle delivery technology, Gylden aims to “prime” recipients’ pre-existing set of naïve CD8+ T cells in order to generate a dedicated CD8+ T cell army of “First Responders”, to kill cells that become infected by an incoming viral pathogen at the time of initial infection, for long-lasting, strain/variant agnostic immune responses. Gylden will develop these T cell priming candidates for ten of the most threatening RNA viruses in the global ecosystem. Gylden also has the largest set of experimentally-determined human viral signature libraries ever to be assembled. This ligandome library is currently being extended to other species, such as avian, bovine, feline, canine etc. This empirical knowledge data set will allow Gylden uniquely to train the latest AI tools to predict pathogen signatures for new pathogens at the point of their discovery and thus reduce time to public health intervention dramatically”.       

Gylden’s Key Accomplishments To Date:

Update on Infectious Disease Clinical Studies

  • Gylden’s TcP candidates against betacoronavirus and dengue have completed Phase I clinical trials in Switzerland. These candidates demonstrated favourable safety profiles and successfully induced virus-specific CD8+ T cell memory subsets, which are critical for long-lasting protection against these viruses in the face of high mutation rates and resultant emergence of new viral variants.
  • Gylden received authorization from the Philippines FDA to initiate a Phase I-II clinical trial for it’s betacoronavirus candidate.
  • The betacoronavirus TcP candidate was selected by NIH/NIAID Project NextGen for inclusion in its repertoire of sponsored clinical trials. The NIH/NIAID programme will support a clinical trial of Gylden’s betacoronavirus TcP candidate and thereby accelerate its development for the potential treatment of SARS-CoV-1 and SARS-CoV-2 across all variants.
  • In collaboration with the Molecular Biology Institute of Paraná (IBMP) in Brazil, an application to the Brazilian Health Regulatory Agency (ANVISA) for regulatory approval of a Phase II dengue study was submitted in January 2025.
  • Utilizing its ligandome platform technology, Gylden has also already identified a library of antigens that could be used to design new TcP candidates for various other infectious diseases including chikungunya, Zika, yellow fever, common cold strain 229E, pandemic influenza, avian influenza, Francisella tularensis, mpox and Ebola/Marburg virus.

Recent Business Activity

 

Anticipated 2025 Priorities and Milestones

Pandemic Preparedness

Gylden’s objective is the establishment of a strategic stockpile of product candidates that can be readily converted to deployable, preventative T cell-Primers designed to protect against a broad range of infectious (including zoonotic) diseases and their existing and emerging variants. These candidates, incorporating Zosano’s microneedle array patch-based [MAP] technology, would be ready for rapid deployment during a pandemic, ensuring rapid and effective protection against widespread disease and public health threats.

  • Gylden plans to develop at least ten Phase I-ready TcP candidates targeting entire families of viruses that drive multiple infectious diseases globally, expanding beyond current products in the pipeline, include new coverage against viral families that include members such as henipaviruses, Lassa fever virus and mpox virus – all emerging viruses with increasing potential for pandemic spread.
  • These TcP candidates will stimulate the specific “First Responder” tissue-resident CD8+ memory T cells, thereby heightening the recipients’ personalized natural immune response (to multiple viral strains), and providing long-lasting, cell-mediated protection, thereby limiting the need for frequent boosters.
  • By leveraging its nanoparticle technology platform, Gylden plans to develop products that are reactive with multiple members of a specific viral family, broadening the immune responses of recipients and minimizing the costly, complex public health developments for fighting future infectious disease threats. As one example, the viral family Flaviviridae encompasses 66+ virus species (i.e. Zika, dengue, West Nile, to name a few), demonstrating the vast potential reach of Gylden protective candidates.
  • Gylden’s extensive product development programme will function not only to serve the public good through efforts to support pandemic preparedness, but will also provide partnering and business development opportunities [i] for Gylden and national/regional biopharmas, as well as [ii] for national governments to strengthen their own local public health activities, including local manufacturing capabilities.

 

Anticipated Infectious Disease Clinical Milestones

  • Gylden anticipates beginning a Phase II clinical trial for dengue fever in Q2 2025 (IBMP collaboration).
  • Through Project NextGen, NIH/NIAID will begin a Phase I trial of the betacoronavirus TcP candidate in Q1/Q2 2025.
  • Gylden will begin a Phase I trial for pandemic influenza, with a planned IND submission in 1H 2025.

 

About Gylden Pharma

Gylden is a clinical stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and R&D and cGMP manufacturing facilities in Milton Park, Oxfordshire, UK, and in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immunotherapy products designed to mimic the body’s natural cellular immune response to identify, destroy and clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to protect against some of the world’s most deadly health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunization into the epidermal layer: this approach is designed to reduce the personnel burden, cold chain complexity, and logistics associated with conventional delivery and preventive measures. Gylden’s first indications pursued are against infectious diseases: [i] including core candidates for betacoronaviruses, dengue fever and universal influenza (including pandemic influenza), as well as [ii] intra-cellular bacterial infectious disease, such as tularemia, caused by Francisella tularensis. Additional candidates include MAP-based products for a number of metabolic indications, as well as a cancer immunotherapy.

Find out more online at www.gyldenpharma.com

Visit our LinkedIn page or Twitter (X) account for updates.

For further information, please contact:

Gylden Media Inquiries
Storme Moore-Thornicroft, Executive Director
Phone: +44 (0) 1235 527589
Email: S.MThornicroft@gyldenpharma.com		 Rachelle Babb, Account Supervisor
Phone: +1 (929) 325-7559
Email: rachelle.babb@russopartnersllc.com

Emergex Announces Company Name Change to “Gylden Pharma Limited” Reflecting Company’s Commitment to Advanced Core Technologies and Expanded Product Pipeline

Abingdon, United Kingdom, 17 October 2024 – Emergex Vaccines Holding Limited, a clinical-stage biotechnology company that is addressing major global infectious diseases through the development of synthetic T cell-priming vaccine and immunotherapy candidates, today announced that the Company has changed its name to Gylden Pharma Limited (‘Gylden’ or the ‘Company’). The name change reflects the Company’s expanded product pipeline – that along with a focus on infectious disease prophylactic vaccines and advanced proprietary core technologies, includes advanced delivery and R&D assets acquired via the purchase of Zosano Pharma in October 2022. The Company’s broadened core technologies (that include not only a nanoparticle-based delivery platform but also microneedle array patch and immunoproteomics / multi-omics technologies, as well as in-house cGMP nanomedicine manufacturing capabilities) have enabled the restructure of its overall product pipeline, allowing for the expansion into other disease indications.

The name, “Gylden,” comes from the Old English word for “golden”, and is a metaphoric nod to the Company’s flagship technology platform which utilises gold nanoparticles to deliver vaccines/immunotherapeutics consisting of targeted synthetic peptides to the skin-resident immune system to elicit a robust T cell immune response.

The parent company, headquartered in the UK shall henceforth be named Gylden Pharma Limited. The main US subsidiary name is Gylden USA Corporation and it owns Zosano Pharma in Fremont, CA. The corporate logo remains unchanged.

Professor Thomas Rademacher, Co-Founder and CEO at Gylden Pharma, commented: “The name “Gylden” is a reflection of the technology-driven nature of our unique nanoparticle-based platform to deliver innovative vaccines and immunotherapies. Our core nanotechnology enables the delivery of immunologically-relevant pathogen peptides essential to generating targeted, robust T cellular immune responses protective against emerging viral and bacterial threats. Viral epidemics pose a serious threat to human health worldwide. Gylden’s highly versatile technology platform is designed not only to facilitate rapid and scalable manufacturing of these vaccines/immunotherapies against many different infectious pathogens but also, owing to their long shelf-life characteristics and absence of cold-chain logistics, to distribute these products to hard-to-reach geographies with significant medical need. The expansion of our core technologies also allows us to generate product candidates in commercial markets additional to infectious diseases, namely cardiometabolic and cancer.”

The Company has already undergone significant expansion of its technology invention and clinical efforts, and anticipates its continued growth as a technology-driven organization. Achievements to date include successfully demonstrating the safety of, and proof of concept for, its technology platform with first-in-human clinical trials of T cell-priming vaccine candidates against Dengue and Betacoronavirus diseases (formal names: naNO-DENGUE and naNO-COVID, respectively, described here and here).

The Company’s acquired Zosano microneedle array patch-based [MAP] technology (announced here) are advancing in various stages of clinical development, with one Zosano product (a migraine treatment) in process to be the granted FDA marketing authorization. Prior preliminary studies completed, which combined Zosano’s MAP technology with its T cell-priming candidates consolidate the Zosano platform’s potential and support the development of our many T cell-priming candidates. The Company has also initiated another immunotherapy programme, in personalized pancreatic cancer treatment, with potential for expansion into other cancer types.

The Company has focused on strategic global partnerships with government health authorities to support further clinical development and thus ensure that its product candidates can reach territories where those infectious diseases strike the hardest.

Importantly, following the Manufacturing and Import Authorisation (MIA) Investigational Medicinal product (IMP) license and cGMP accreditation received by the Company earlier in 2024 (issued by the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA]), the new Company name further reflects those hard-earned capabilities.

About Gylden Pharma

Gylden is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and R&D and cGMP manufacturing facilities in Milton Park, Oxfordshire, UK, and Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming vaccines/immunotherapies designed to mimic the body’s natural cellular immune response to destroy and to clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Gylden’s first indications pursued are against infectious diseases: [i] including core candidates for Betacoronaviruses, Dengue Fever and Universal Influenza (including Pandemic Influenza), as well as [ii] intra-cellular bacterial infectious disease, such as tularemia, caused by Francisella tularensis. Additional products include MAP-based products for a number of metabolic and other indications, as well as a cancer immunotherapy. Gylden has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention of RNA viral infections and immunotherapy in other therapeutic categories.

Find out more online at www.gyldenpharma.com

Emergex T Cell-Priming Vaccine Candidate for Betacoronaviruses selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

– NIAID will be conducting and sponsoring clinical trials to accelerate and to streamline the rapid development of next-generation COVID-19 vaccines.

ABINGDON, United Kingdom, October 2, 2024— Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming vaccine candidates,  today announced that the National Institute of Allergy and Infectious Diseases (NIAID),  part of the National Institutes of Health (Bethesda, MD, USA), has selected Emergex for inclusion in its Project NextGen. Through Project NextGen, NIAID is conducting early phase clinical trials on select next-generation SARS-CoV-2 vaccine candidates covering a broad range of platforms, including T cell vaccines. The objective of Emergex’s T cell-based platform is to generate a protective cellular immune response, specifically the generation of tissue-resident memory CD8+ T cells and, in the case of SARS-CoV-2,  can provide a rapid recall response locally in the respiratory tract leading to an abortive infection. Induction of  variant agnostic  and long-lasting cell-mediated protection will limit the need for frequent boosters.  The Emergex vaccine, CoronaTcP, is designed to be broadly effective against Betacoronavirus infections, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, said “We are thrilled that our immunotherapy candidate for Betacoronaviruses, which has already demonstrated an excellent safety profile and shown to be capable of eliciting targeted CD8 T cell immune memory, has been selected as part of the Project NextGen initiative. Our T cell-based platform technology has the potential to address current and future coronavirus challenges and thereby strengthen preparedness for future pandemics, through harnessing the natural course of cellular immunity by ensuring rapid, targeted and robust immune responses against emerging infectious threats.”

Emergex’s CoronaTcP candidate has demonstrated in a completed Phase I clinical trial in Switzerland to have a favorable safety profile and to successfully induce epitope-specific CD8+ memory subsets, which are critical for long-lasting protection against Betacoronaviruses in the face of high mutation rates and continuous emergence of new variants of those viruses. The Company also employs a variety of microneedle devices to achieve transdermal administration of its vaccines, which are 100% synthetic, and to facilitate development of both systemic and tissue-resident CD8 T cell memory responses.  In addition, this delivery approach can overcome logistical constraints of traditional vaccines which require cold-chain measures during shipping, manufacturing, and conventional administration by healthcare professionals, all of which elements can significantly restrict global accessibility.

Emergex looks forward to this important next step in the development of its novel T cell-priming Betacoronavirus candidate. NIAID is projected to cover the full cost of the Phase I clinical trial, including operations and related analyses. Emergex will be responsible for providing clinical trial materials and documentation required for an investigational new drug (IND) submission.

About Project NextGen

Project NextGen is a $5 billion initiative to accelerate and to streamline the rapid development of next generation vaccines, drugs and treatments through public-private collaborations. Led by NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), Project NextGen is a coordinated effort between the US Federal Government and private sector to advance the pipeline of innovative vaccines, drugs and therapeutics from labs into clinical trials, with the intent to transition to the private sector in later stage development and proceed to potential US Food and Drug Administration (FDA) authorization, approval, and then commercial availability.

About Emergex

Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, Oxon, UK, with an operating subsidiary in Doylestown, Pennsylvania, a microneedle manufacturing facility in Fremont, CA, USA and GMP production vaccine facility in Milton Park, UK. The Company is pioneering the development of 100% synthetic T cell-priming vaccine candidates designed to mimic the body’s natural T cell immune response to destroy and clear pathogen-infected cells, in order to protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel microneedles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Pandemic Influenza candidates, as well as [ii] intracellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative immunotherapy candidates with the potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Emergex Receives Patent Protection for First-in-Class Influenza A Vaccines with Potential to Provide Long-Term T Cell Immunity

  • – Breakthrough patent represents a significant leap in influenza pandemic preparedness, solidifying the company’s innovative approach for influenza vaccine development with viral peptides derived from a negative-sense strand of the viral genome

Abingdon, United Kingdom, 22 August, 2024 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming vaccine candidates, today announced that Emergex has received patent protection from the United States Patent and Trademark Office (USPTO) for its novel class of influenza vaccines that have the potential to provide long-term T cell immunity against all legacy strains of influenza A since 1918, as well as seasonal variants and heterosubtypic changes. This groundbreaking patent covers Emergex’s vaccine comprising in part immunogenic peptides encoded by a negative sense
open reading frame (ORF) from segment 8 of the influenza A genome. To Emergex’s knowledge, this represents the first known patent for viral peptides derived from antigenomic translation suggesting that segment 8 of influenza A is ambisense (negative and positive sense ORFs).1In addition, this grants the company exclusive rights to develop a vaccine that incorporates these immune elements, offering a level of immune recognition that existing flu vaccines are unable to provide either because of composition or method of administration. This also further expands Emergex’s impressive portfolio of approximately 100 technology inventions across various technologies and jurisdictions.

A large ORF in the negative sense strand of segment 8 in human influenza A virus (NEG8) has been conserved for over 100 years.2 The length of the NEG8 ORF is represented by three epochs and each epoch change (i.e pandemic index strain) has corresponded to the onset of a global H1N1 pandemic. Although previously not thought to be translated, Emergex has successfully identified a number of peptides that are presented by MHC class I molecules on influenza-infected cells and that are encoded by NEG8. Cluster stacks of these NEG8-derived epitopes as determined by immunoproteomics are conserved across influenza A serotypes (epoch related) and are potential key targets for inducing heterologous CD8 T cell immunity and therefore are optimal for inclusion in pandemic preparedness vaccines. Additionally, incorporation of avian- and equine species-specific NEG8 derived peptides in a vaccine also has the potential to expand protection to zoonotic transmissions.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer at Emergex, commented: “Our research into NEG8 has revealed exciting potential for a new approach to influenza vaccines. We believe that a vaccine composition including conserved NEG8-derived MHC class I peptides could provide protection against past, existing, and emerging human influenza viruses, as well as prevent zoonotic influenza viruses from establishing themselves in the human population and causing a pandemic. Emergex aims to leverage this NEG8 epitope-containing vaccine to generate a durable and broadly-protective cellular immune response upon vaccination.” Emergex is set to advance its first-in-class influenza vaccine into the clinic, with Phase I trials anticipated to begin in the first half of 2025.

1 Strauss JH, Strauss EG. Overview of Viruses and Virus Infection. Viruses and Human Disease. 2008:1–33.
2 Clifford M, Twigg J, Upton C. Evidence for a novel gene associated with human influenza A viruses. Virol J. 2009;6:198.

About Emergex

Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic T cell-priming vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Pandemic Influenza candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.gyldenpharma.com.

Visit our Twitter (X) account

For further information, please contact:

Emergex <strong
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@gyldenpharma.com

 Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

1 Trademark application submitted

Emergex Announces MHRA Approval of MIA (IMP) Manufacturing and Import Authorisation License

Abingdon, United Kingdom, 18 June 2024 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming vaccine candidates, today announced that Emergex has received its Manufacturing and Import Authorisation (MIA) Investigational Medicinal Product (IMP) license from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to advance its novel T cell-priming vaccine candidates into clinical production. This will provide cGMP grade vaccine Drug Substance to support Emergex’s clinical trial pipeline.

Emergex’s MIA (IMP) license and cGMP accreditation, issued on 16 April 2024 [MIA (IMP) 57419] follows a rigorous multi-phase regulatory audit inspection of its GMP Quality Systems, Facilities, and Manufacturing Areas, conducted in September 2023 and March 2024.

Laszlo Fekete, Quality Director at Emergex, commented: “We are thrilled to announce the GMP certification of our in-house facilities, a critical milestone that allows us to confidently proceed with production of our novel T cell-priming vaccine candidates into clinical use. The infectious disease solutions we are developing aim to address significant unmet medical needs, offering the potential to provide coverage for billions of individuals at risk for dengue and pandemic influenza, among other urgent global health challenges. The MIA (IMP) license grants us the privilege and responsibility to manufacture clinical-grade products to protect these huge at-risk populations.”

Laurens Rademacher, Chief Technology Officer at Emergex added: “For Emergex, this is a milestone we have been working towards since its formation in 2016. Over the years, we have been dedicated to building the necessary infrastructure and establishing key collaborations in high-impact countries around the world. This has included developing innovative technologies such as the Stericube, outsourcing manufacturing in order to most efficiently scale our production capabilities, and engaging in technology transfer strategies to enhance the global reach and impact of our vaccine candidates to where they are needed most. Notably, our strategic ties with entities in Brazil and Saudi Arabia have been crucial in advancing our joint goals with potential to expand access in diverse markets.”

The MHRA is an executive agency of the UK Department of Health and Social Care, which is responsible for ensuring that medicines and medical devices properly work and are acceptably safe. MHRA licensing is globally recognized for requiring the highest standards of safety, quality and effectiveness for any vaccine. The receival of the MIA (IMP) license makes Emergex the only dedicated gold nanoparticle T cell vaccine cGMP facility in the world.

Emergex’s innovative T cell-based vaccines are unique in that they are 100% synthetic in composition, shelf stable for over 3 months at ambient temperatures, and designed to provide long-term and mutation-agnostic coverage against existing and emerging strains of viruses of the same virus family. Designed for delivery via novel microneedle technology, their scalable design and ease of administration facilitates manufacture in bulk, which is particularly crucial during the emergence of pandemics. Furthermore, their design offers improved access to remote and under-resourced regions of the world.

About Emergex

Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic T cell-priming vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Pandemic Influenza candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.gyldenpharma.com.

Visit our LinkedIn page Twitter (X) account

 

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@gyldenpharma.com

 

 Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

 

1 Trademark application submitted

Emergex Announces R&D Collaboration with DEKA Research & Development Corp. for Assessment of Emergex’s Immunotherapeutic Candidates with DEKA’s Intradermal Therapeutic Applicator

  • – Emergex has entered into an agreement with DEKA Research & Development (‘DEKA’) to assess the compatibility of Emergex’s T cell-priming set-point immunotherapeutic candidates with DEKA’s Intradermal Therapeutic Applicator. The collaboration builds on previous data showing satisfactory loading and stability of Emergex’s therapeutic candidates when incorporated with the Intradermal Therapeutic Applicator.
  • – The collaboration also covers completion of a preclinical study to compare the pharmacokinetics of [i] Emergex’s Dengue treatment candidate by syringe-based microneedle technology, which have been used in previous preclinical and clinical Emergex studies, with [ii] DEKA’s Intradermal Therapeutic Applicator.
  • – Pending preclinical study results, the agreement allows for the possibility of advancing the Intradermal Therapeutic Applicator as an administration device for Emergex’s pipeline of treatments for viral diseases.

Abingdon, United Kingdom, 16 January 2024 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming set-point immunotherapy-based treatment candidates, today announced that the Company has entered into an agreement with DEKA to assess the compatibility of Emergex’s immunotherapeutic candidates with the DEKA Intradermal Therapeutic Applicator.

The Intradermal Therapeutic Applicator incorporates hollow microneedle technology into a convenient self-administration device. This agreement builds on previous data showing satisfactory loading and stability of Emergex’s product candidates when incorporated into the Intradermal Therapeutic Applicator.

Laurens Rademacher, Chief Technology Officer at Emergex, added: “We are delighted to announce this important collaboration with DEKA. Intradermal/Epidermal delivery is critical to the mechanism of our T cell-priming product platform. The use of microneedles, which have been utilized in all our previous preclinical and clinical work, paired with the ease-of-use of the Intradermal Therapeutic Applicator is a perfect complement to our own technologies.”

The agreement covers completion of a preclinical pharmacokinetic study to compare the delivery of Emergex’s DengueTcP1 product candidate by syringe-based microneedle technology versus the DEKA Intradermal Therapeutic Applicator. Pending completion, if promising data is obtained, the agreement allows for the possibility of advancing DEKA’s Intradermal Therapeutic Applicator as a device for administration of Emergex’s T cell-priming set-point immunotherapeutic product candidates in the pipeline.

Dean Kamen, Founder and President, of DEKA Research & Development, commented: “The partnership with Emergex is a meaningful step forward in patient therapeutic delivery. The combined technologies of our novel intradermal therapeutic delivery platform along with Emergex’s products can open a new route to intradermal drug administration in a patient friendly, easy-to-use, painless way. We are excited by the potential of our combined technologies in saving numerous lives.”

About DEKA Intradermal Therapeutic Applicator
DEKA’s technology leverages hollow microneedles that offer a unique design with flexible features for efficient therapeutic delivery, self-administration and minimal pain. With a simple push of the top button on the device, the petal design spreads outward, thereby stretching the skin and enabling a consistent insertion of the microneedles into the skin. The continued downward motion then activates the trigger that applies pressure to the reservoir to expel the therapeutic agent into the intradermal region. Numerous advantages of this device include self-administration, dose-sparing and less overall waste than conventional needles

About DEKA Research and Development
Based in Manchester, NH, DEKA Research & Development Corp. is a technology development organization. The company was founded in 1982 by Dean Kamen.

Find out more online at www.dekaresearch.com.
Visit our LinkedIn page for updates.

 

About Emergex

Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.gyldenpharma.com.

Visit our LinkedIn page or Twitter account for updates.

 

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@gyldenpharma.com

 

 Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

 

1 Trademark application submitted

Emergex Announces Authorisation from Philippines FDA to Initiate Phase I-II Clinical Trial of CoronaTcP™

  • – Emergex received authorisation from the Philippines FDA to launch a Phase I-II clinical trial of CoronaTcP, its T cell-priming immune set-point candidate against Betacoronaviruses.
  • – Emergex is progressing trial initiation plans, with an anticipated start date in Q2 2024.

ABINGDON, United Kingdom, 3 January 2024 – 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 that the Philippines Food & Drug Administration has authorised the initiation of a Phase I-II clinical trial of CoronaTcP™1, Emergex’s 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.

The naNO-COVID 2 trial (NCT05633446) is a randomized, double-blind, placebo-controlled Phase I-II trial in the Philippines, which will investigate the safety and immunogenicity of CoronaTcP. The study is expected to enrol 110 healthy volunteers (18–75 years of age), who will each receive either one or two doses of CoronaTcP or placebo. All participants will be followed up for six months.

This study follows completion of the naNO-COVID trial (NCT05113862), a Phase I clinical trial in Switzerland which demonstrated that CoronaTcP had a favourable safety profile and successfully induced virus-specific CD8+ memory subsets.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, commented: “We thank the Philippines FDA for rapidly approving this trial after a successful Phase I clinical trial in Switzerland. Coronaviruses are susceptible to high mutation rates, and cellular immunity is critical for long-lasting protection. We look forward to evaluating our T cell-based approach, which has the potential to improve any previous immune status. Emergex is rapidly moving forward with plans for the trial, and we expect to start enrolling volunteers in Q2 2024.”

The naNO-COVID 2 trial
The naNO-COVID 2 trial (NCT05633446) is a Phase I-II, double-blind, randomized, placebo-controlled study investigating the safety and immunogenicity of a T cell-priming immune set-point candidate for coronavirus disease in healthy adults. The clinical study will enrol 110 participants, who will be randomized into the following groups: Group 1: one vaccination on Day 0 (n=55): 44 CoronaTcP + 11 placebo; Group 2: two vaccinations on Day 0 and Day 21 (n=55): 44 CoronaTcP + 11 placebo. Overall, 88 participants will receive CoronaTcP (7.5 nmol peptide per dose) and 22 will receive placebo (water for injection). Safety and immunogenicity of CoronaTcP (cellular and humoral immune responses) during the six-month post-vaccination period will be evaluated.

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.gyldenpharma.com.

Visit our LinkedIn page or Twitter account for updates.

1 Trademark application submitted

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@gyldenpharma.com

 

 Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

Successful Transfer of New Drug Application (NDA), Acknowledged by U.S. FDA, from Former Zosano Pharma to Emergex for Investigational Microneedle-Based Drug Delivery Patch

  • – Earlier this year, Emergex submitted a notification to the FDA regarding the transfer of ownership of Zosano Pharma’s Microneedle Array Patch (MAP) epidermal drug delivery system to Emergex itself following its acquisition of the operating assets of Zosano, which has been acknowledged by the FDA with the update reflected in its records.
  • – Emergex requested a 12-month extension to the submitted NDA to work toward potential marketing authorization of Zosano’s microneedle-based drug delivery patch originally intended to deliver zolmitriptanTM for the treatment of migraines, which will also be repurposed for the delivery of Emergex’s T cell-priming candidates. The FDA has acknowledged the extension request.

Abingdon, Oxon, UK, 18 December 2023 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of T cell-priming, immune set-point drug candidates, today announced that the Company has transferred ownership, as of May 2023, of the existing U.S. Food and Drug Administration (FDA) New Drug Application (NDA) of the investigational MAP originally intended for the epidermal delivery of zolmitriptan1 (also known as M207) for the treatment of migraine attacks in adults. This transfer from the former California-based Zosano Pharma Corporation (Fremont, CA) follows the acquisition of Zosano operating assets by Emergex. Additionally, Emergex has notified the FDA of its request for a 12-month extension of the NDA.

On October 12, 2022, Emergex announced its acquisition of Zosano assets, including intellectual property, license agreements, and manufacturing equipment, as well as Zosano’s proprietary MAP epidermal drug delivery system.

Emergex had previously performed proof-of-concept studies with Zosano MAP technology-based microneedle patches coated with Emergex T cell-priming immune set-point candidates, observing favourable results regarding ease-of-use and shelf-life characteristics. The acquisition provided Emergex with innovative technology, among other assets, and optimised manufacturing capabilities that can be deployed for, and integrated with, the development roadmap of Emergex’s T cell-priming candidates. In April 2023, Emergex notified the FDA of that acquisition, as a full NDA package which had previously been filed with the FDA by Zosano.

Emergex also notified the FDA of an extension of Zosano’s submission of epidermal migraine treatment patch NDA for potential marketing authorization. The extension will allow Emergex to continue manufacturing the epidermal delivery patch with its own pipeline of T cell-priming candidates.

Laurens Rademacher, Chief Technology Officer at Emergex, commented: “The successful transfer of the NDA marks an important milestone in our goal to lead a new generation of treatments for acute viral infections. We look forward to expanding upon the promise of this MAP technology and are confident that its combination with our T cell-priming candidates will further advance Emergex’s core mission to combat viral threats around the world. We now have a highly sophisticated vaccine platform paired with a pragmatic delivery tool, which we believe makes a recipe for success”

1 Zolmitriptan is an active drug used to treat acute migraine headaches in adults, currently available under various brand names, such as Zomig®, among others.

About Epidermal Delivery and MAP Technology

Microneedle array patch (MAP) technology facilitates the use of coated microneedles for epidermal delivery of Emergex immunotherapy candidates to treat acute viral diseases. The novel technology has previously been validated with Emergex products in proof-of-concept studies. The use of MAP technology is intended to overcome the limitations imposed on supply chain logistics by traditional vaccine approaches, which require colder temperatures during both shipping and manufacture and greatly limit global accessibility. The technology also takes advantage of the high levels of antigen-presenting cells present in the skin to induce a stronger immune response
while using smaller quantities of antigens. Collectively, the novel drug delivery strategy is intended to provide an effective delivery tool with limited reliance on costly and complex supply chain logistics.

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Visit our LinkedIn page or Twitter account for updates.

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@gyldenpharma.com

 

 Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

Emergex Signs Contract of £1,79M with the UK Department of Health and Social Care’s UK Vaccine Network (“UKVN”) to Advance Its Novel Synthetic T Cell-Priming Set-Point Candidate Against Chikungunya Virus

Abingdon, United Kingdom, 17 November 2023 – Emergex Vaccines Holding Limited (‘Emergex’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of 100% synthetic T cell-priming immune set-point candidates, today announced that it has signed a contract with the UK Department of Health and Social Care for £1,798,109 to advance a CD8 T cell-based vaccine candidate against Chikungunya virus (CHIKV).

CHIKV is a mosquito-transmitted alphavirus that causes epidemics of illness characterized by debilitating arthralgia and arthritis that can endure for months to years following infection. In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.

The milestone-based contract is designed such that Emergex will advance the development of a CD8 T cell-priming Chikungunya virus (CHIKV) vaccine candidate (PepGNP-ChikV) through preclinical studies, manufacture the vaccine candidate under Good Manufacturing Practice (cGMP) standards, and apply for MHRA regulatory submission for a Phase-1 clinical trial in the UK. The programme is intended to position Emergex for entry to the clinic by its completion, ready to begin a Phase-1 clinical trial.

Laurens Rademacher, Chief Technology Officer of Emergex commented, “We are greatly looking forward to continuing development of our novel T cell-priming solutions against leading and reemerging global health threats of epidemic potential. Through this meaningful contract, we are pleased that the UK government and its advisors recognize the potential of our innovative technology in contribution to global epidemic (and pandemic) preparedness. The focus of this opportunity on developing groundbreaking solutions targeted to entire families of viruses aligns well with Emergex’s core mission and capabilities. Our T cell-priming set-point candidates are designed to deliver robust and long-lasting protection against current and existing strains of RNA viruses, from Influenza to Chikungunya, and to ultimately increase vaccine accessibility in endemic regions.”

This news follows a previous announcement in February 2022, highlighting a contract awarded by UK government’s Department of Health and Social Care (‘DHSC’) in support of the development of Emergex’s Chikungunya vaccine candidate prototype stages of which included 1) identification of novel CHIKV peptide antigen epitopes (collectively constituting Emergex’s “ligandome”), 2) synthesis of a vaccine candidate, and 3) testing in in vitro efficacy models. Subsequently, Emergex achieved all milestones priming the CHIKV candidate for progression to the next stage of its preclinical development.

Dr Phil Packer, Innovation Lead, AMR and Vaccines, from UK Research and Innovation (UKRI) added: “Innovate UK are delivering a further (£40M) Programme for DHSC to develop vaccines against diseases that have outbreak potential. This exciting project, spearheaded by Emergex, will pave the way for development of a vaccine against Chikungunya Virus that will be ready for evaluation in human clinical trials. This brings us one step closer to providing a solution that, if successful, will have huge benefit for people in Low- and Middle- Income Countries where this disease is most prevalent.”

Using the Emergex T cell-priming platform, Emergex has successfully completed Phase I trials of Dengue and Betacoronavirus vaccine candidates (DengueTcPTM1 and CoronaTcP, respectively) under Swiss Medic, which were shown to be safe and capable of inducing desired T cell effector and memory responses. A Phase-2 trial for CoronaTcP and a Phase-1 trial for a Universal Influenza vaccine candidate are planned in H1 2024.

About Chikungunya

Chikungunya is an alphavirus (group of RNA viruses) and genus of the Togaviridae family of viruses. It is transmitted through the bite of an infected mosquito and can cause epidemics of infectious disease. The illness is characterized by fever, rash, debilitating joint stiffness (arthralgia) and arthritis, which can endure for months to years following infection. Endemic in most countries in Central and South America and the Caribbean with first local transmission identified over the past decade, CHIKV cases have been reported in Europe, Asia, the Pacific region, as well as the Americas. An increasing trend in CHIKV cases has been observed in the Americas in recent years; in this region collectively, a four-fold increase in CHIKV cases and deaths has been reported between 1 January and 4 March 2023, compared with the same time period in 2022.2 Epidemics of CHIKV can severely impact the economy. It was announced last week that the U.S. Food and Drug Administration (FDA) has approved under accelerated approval a single-dose, live-attenuated vaccine for individuals over 18 years of age at increased risk of exposure to chikungunya virus (CHIKV) for the prevention of disease based on anti-CHIKV neutralizing antibody titres, the clinical benefit of which is contingent upon verification in confirmatory studies.

About UK Vaccine Network (“UKVN”)

This research was funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs). It was delivered by Innovate UK.

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 an 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).

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Visit our LinkedIn page or Twitter account for updates.

1 Trademark application submitted
2 https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON448

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@gyldenpharma.com

 

 Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

 

Emergex and Saudi Arabia’s Vaccine Industrial Company (VIC) have signed MoU to Advance First-of-its-Kind Infectious Disease Solutions

  • – Emergex and VIC plan to collaborate to further develop and commercialise Emergex’s proprietary T cell-based vaccine candidates as designated in Saudi Arabia and the agreed Territory (including GCC Member States, other Middle Eastern territories and specified regions).

    – The Collaboration Agreement ultimately shall grant VIC first rights to distribute potential licensed products and to fill and finish activities in Saudi Arabia and the Territory.

    – This Collaboration supports the Kingdom of Saudi Arabia’s Vision 2030 to boost the biopharma sector through increasing local and regional production as well as accessibility of healthcare solutions.

ABINGDON, United Kingdom, October 05, 2023 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’) a clinical-stage biotechnology company on the forefront of combatting global infectious diseases, has announced that the Company has signed a Memorandum of Understanding with the Vaccine Industrial Company (VIC) for a Collaboration Agreement advancing Emergex’s novel T cell-priming immune set-point candidates against designated infectious diseases. This follows recent announcements of promising data reported from successful completion of Phase I clinical trials of candidates for Betacoronaviruses and Dengue Fever. Currently, Saudi Arabia has an entirely nascent market in infectious disease solutions and has established companies such as VIC to position itself and associated territories as a global biotech hub to facilitate serious initiatives to localize the biotechnology industry and harness novel technologies to address this. This agreement is a testament to Emergex’s promising technology as a vital contributor to game changing healthcare solutions around the world.

Under the terms, VIC intends to take an equity stake in Emergex, subject to government support of Phase II/III clinical trials of Emergex’s T cell-priming candidates for Dengue, Coronavirus, Influenza, Yellow Fever, including add-on products related to these indications. VIC shall have a Right of First Negotiation (“ROFN”) over new candidates proposed by Emergex for the Territory. The venture would grant VIC exclusive rights to marketing and distribution of potential licensed products, as well as fill and finish activities for potential licensed products within Saudi Arabia and the designated Territory, with Emergex’s assistance for any technology transfer.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, commented, “This partnership with VIC propels our candidates into territories where these diseases strike hardest, where treatments are desperately needed. With this Memorandum, marking our second government-affiliated collaboration, we are delighted that global organizations recognize Emergex’s promise. We remain dedicated to forging these alliances in order to extend the reach of our candidates worldwide.”

Dr. Khaled Almosa, Founder and Chief Executive Officer of VIC added, “We welcome the opportunity to work with Emergex at a time when infectious disease prevention is a priority to the Saudi Arabian government and people. Emergex’s novel approach offers a safe, easy-to-administer and highly effective solution, alternative to mainstream methods, to protect against infectious diseases. Advancing such innovative technologies locally will greatly contribute to Saudi Arabia’s Vision 2030 to become a global biotech hub, making headway toward greater vaccine accessibility and reducing dependance on other countries for vital healthcare solutions.”

Joining hands with forward-thinking biotech organizations such as VIC marks an important milestone for Emergex. Such partnership fortifies critical health infrastructure within regions such as the Middle East and North Africa (MENA) that are historically difficult for biopharma to reach, playing a pivotal role in safeguarding the public’s health against the looming threat of infectious diseases.

About Vaccine Industrial Company (VIC)

Vaccine Industrial Company (VIC) is a Saudi Arabian company based in Riyadh and founded in January 2022 by Dr. Khaled Almosa, a health care management consultant. Dr. Khaled is the Founder, Vice Chairman and Managing Director of Saudi Biotechnology Manufacturing Company for Insulin and Biologics (2010-2020), Member of Supreme Committee for Research, Development and Innovation, Council of Economic & Development Affairs, Council of Ministers, Saudi Arabia. VIC is the first and only company aiming to set up a state-of-the-art vaccine manufacturing facility in Saudi Arabia.

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

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

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@gyldenpharma.com

 

 Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com