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
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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, Senior Account Executive Phone: +1 (929) 325-7559 Email: rachelle.babb@russopartnersllc.com |
