Gylden Pharma Ltd.

ABINGDON, United Kingdom, Oct. 17, 2024 (GLOBE NEWSWIRE) -- 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 Visit our LinkedIn page or Twitter (X) account for updates. For further information, please contact: GyldenMedia Inquiries Storme Moore-Thornicroft, Executive Director Phone: +44 (0) 1235 527589 Email: S.MThornicroft@gyldenpharma.com Rachelle Babb, Senior Account Executive Phone: +1 (929) 325-7559 Email: rachelle.babb@russopartnersllc.com

NIAID will be conducting and sponsoring clinical trials to accelerate and to streamline the rapid development of next-generation COVID-19 vaccinesABINGDON, United Kingdom, Oct. 02, 2024 (GLOBE NEWSWIRE) -- 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. Find out more online at www.emergexvaccines.com. Visit our LinkedIn page or Twitter (X) account for updates. For further information, please contact: EmergexStorme Moore-Thornicroft, Executive Director & Chief Operating OfficerPhone: +44 (0) 1235 527589Email: smt@emergexvaccines.com Media InquiriesRachelle Babb, Senior Account ExecutivePhone: +1 (929) 325-7559Email: rachelle.babb@russopartnersllc.com

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, Aug. 22, 2024 (GLOBE NEWSWIRE) -- 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).1 In 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. 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 to 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] 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.emergexvaccines.com. Visit our LinkedIn page or Twitter (X) account for updates. For further information, please contact: EmergexStorme Moore-Thornicroft, Executive DirectorPhone: +44 (0) 1235 527589Email: smt@emergexvaccines.comMedia InquiriesRachelle Babb, Senior Account ExecutivePhone: +1 (929) 325-7559Email: rachelle.babb@russopartnersllc.com 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.