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, Feb. 24, 2025 (GLOBE NEWSWIRE) -- 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

• Gylden received patent protection from the United States Patent & Trademark Office (USPTO) for its novel class of influenza TcP candidate (that includes immunogenic, synthetic peptides corresponding to viral peptides derived from antigenomic translation) that has 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.

• The Company also received its Manufacturing and Import Authorisation (MIA) Investigational Medicinal Product (IMP) license from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), issued in April 2024, for its manufacturing facility at Milton Park, allowing the facility to provide cGMP-grade Drug Substance throughout Gylden’s clinical trial pipeline.

• Gylden signed a contract with UK Department of Health and Social Care’s UK vaccine Network (UKVN) to advance clinical development of a synthetic TcP candidate against chikungunya virus.

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

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