Gylden Pharma Limited is set to expand its infectious disease portfolio in 2025 through multiple clinical trials of its innovative T cell-priming (TcP) technology platform. The clinical-stage biotechnology company's ambitious program targets major global infectious diseases using synthetic nanoparticle constructs designed to prime protective immune responses.
Clinical Trial Pipeline Expansion
The company's development program includes several key initiatives scheduled for 2025. A Phase II trial for dengue fever is expected to commence in Q2 2025 in collaboration with Brazil's Molecular Biology Institute of Paraná (IBMP). Additionally, through the NIH/NIAID Project NextGen, a Phase I trial for their betacoronavirus candidate will begin in Q1/Q2 2025. The company also plans to submit an IND for a Phase I trial targeting pandemic influenza in the first half of 2025.
Revolutionary T Cell-Priming Technology
"Gylden's 'plug-and-play' product development platform enables rapid deployment of proprietary target peptide sequences for various dangerous pathogens," explained Professor Thomas Rademacher, MD, PhD, Co-founder and CEO of Gylden Pharma. The platform utilizes experimentally-determined viral MHC class I and II ligandome libraries to generate long-lasting, strain-agnostic immune responses.
The technology aims to prime recipients' naïve CD8+ T cells, creating a dedicated army of "First Responders" capable of eliminating infected cells at the initial stage of infection. This approach has shown promising results in early clinical trials, with both betacoronavirus and dengue candidates demonstrating favorable safety profiles and successful induction of virus-specific CD8+ T cell memory subsets.
Pandemic Preparedness Initiative
A cornerstone of Gylden's 2025 strategy is the development of approximately 10 "First Responder" immune TcP candidates ready for Phase I clinical trials. These candidates will target entire viral families, including emerging threats such as henipaviruses, Lassa fever virus, and mpox virus.
The company's strategic stockpile will incorporate Zosano's microneedle array patch-based technology, enabling rapid deployment during pandemic situations. This innovative delivery system aims to reduce personnel burden, cold chain complexity, and logistical challenges associated with conventional vaccination methods.
Manufacturing and Regulatory Achievements
Gylden's manufacturing capabilities received a significant boost with the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) granting a Manufacturing and Import Authorisation for their Milton Park facility. This authorization enables the production of cGMP-grade Drug Substance for their clinical trial pipeline.
The company has also secured important intellectual property protection, receiving a USPTO patent for their novel influenza TcP candidate. This technology has the potential to provide long-term T cell immunity against all influenza A strains since 1918, including seasonal variants and heterosubtypic changes.
Global Collaboration and Future Prospects
Gylden's expansion includes strategic partnerships with various organizations, including a contract with the UK Department of Health and Social Care's UK Vaccine Network to develop a synthetic TcP candidate against chikungunya virus. The company's extensive viral signature libraries are being extended to multiple species, positioning Gylden to leverage AI tools for rapid pathogen signature prediction and accelerated public health interventions.
