
LONDON, UK / ACCESS Newswire / July 24, 2025 – Genflow Biosciences, Europe’s sole publicly traded longevity company, has announced significant progress across two of its lead AAV (adeno-associated virus)-based gene therapy programs: GF-1002 and GF-1004. These advancements underscore the company’s dedication to developing scientifically sound therapies for healthy aging.
GF-1002 Progresses Toward European Clinical Trial Authorization
GF-1002 is a suspension of an AAV vector-based gene therapy for intravenous infusion and intends to improve DNA maintenance by delivering extra copies of the Centenarian Variant. Genflow is accelerating development for GF-1002 as it prepares for a European Clinical Trial Authorisation (CTA) submission, the EU’s equivalent to the U.S. FDA’s IND process. To support this, Genflow has begun Chemistry, Manufacturing, and Controls (CMC) work. Concurrently, pivotal efficacy studies for MASH (Metabolic Dysfunction-Associated Steatohepatitis) treatment are underway to evaluate GF-1002 in both early and advanced disease stages.
GF-1004 Trial Enhanced for Safety and Consistency
For GF-1004, Genflow has submitted a protocol amendment to its ongoing proof-of-concept clinical trial in aged dogs. The amendment clarifies the administration of the investigational product by specifying the intravenous (IV) dose rate. This adjustment aims to ensure consistent, controlled delivery, minimizing infusion-related adverse events and bolstering patient safety. Launched in March, this randomized, controlled trial is designed to assess the safety and efficacy of Genflow’s proprietary SIRT6-centenarian gene therapy in addressing age-related decline in dogs.
CEO Highlights Program Maturity and Strategic Position
Dr. Eric Leire, CEO of Genflow, commented on these developments: “This update reflects the growing maturity of our pipeline and our continued commitment to advancing science-backed therapies in healthy aging. The combination of expected non-dilutive funding, strategic partnerships, and supportive regulatory tailwinds puts Genflow in a strong position to accelerate both our programs.”
Source:
https://www.londonstockexchange.com/news-article/GENF/clinical-readiness-acceleration/17149304
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PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
