Clinical Readiness Acceleration
24 July 2025
Genflow Biosciences Plc
Clinical Readiness Accelerates Across Genflow Biosciences Lead Programs
Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF) ("Genflow" or "the Company"), the only publicly listed longevity company in Europe, is pleased to report key preclinical activities in two of its lead programs.
GF-1002
In preparation for a submission for European Clinical Trial Authorisation (CTA), the EU's regulatory equivalent to the U.S. FDA's IND process, Genflow is continuing to advance key development activities. To support this process, the Company has initiated Chemistry, Manufacturing, and Controls (CMC) work in collaboration with its CDMO partner, Exothera, to ensure clinical supply production meets Good Manufacturing Practice (GMP) standards. In parallel, pivotal efficacy studies are underway with Genflow's independent CRO partners, Physiogenex and Accelera, evaluating GF-1002 in both early and advanced stages of MASH.
GF-1004
Genflow has submitted a first protocol amendment to its ongoing proof-of-concept clinical trial in aged dogs to clarify the administration of its investigational product, GF-1004. The amended protocol now specifies the intravenous (IV) dose rate to ensure consistent and controlled delivery, minimizing the risk of infusion-related adverse events and reinforcing patient safety. This randomized, controlled trial initiated in March in collaboration with the renowned CRO, Syngene is designed to evaluate the safety and efficacy of Genflow's proprietary SIRT6-centenarian gene therapy in addressing age-related decline in dogs.
Dr. Eric Leire, CEO of Genflow, commented: "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."
Contacts
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Genflow Biosciences |
Harbor Access |
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Dr Eric Leire, CEO |
Jonathan Paterson, Investor Relations |
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+32-477-495-881 |
+1 475 477 9401 |
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Jonathan.Paterson@Harbor-access.com |
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Corporate Broker |
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Capital Plus Partners |
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Jonathan Critchley |
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+44 0207 432 0501 |
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About Genflow Biosciences
Founded in 2020, Genflow Biosciences Plc. (LSE:GENF) (OTCQB:GENFF), a biotechnology company headquartered in the UK with R&D facilities in Belgium, is pioneering gene therapies to decelerate the aging process, with the goal of promoting longer and healthier lives while mitigating the financial, emotional, and social impacts of a fast-growing aging global population. Genflow's lead compound, GF-1002, works through the delivery of a centenarian variant of the SIRT6 gene which has yielded promising preclinical results. Genflow's 12-month proof-of-concept clinical trial evaluating their SIRT6-centenarian gene therapy in aged dogs began in March 2025. Other programs planned for 2025, include a clinical trial that will explore the potential benefits of GF-1002 in treating MASH (Metabolic Dysfunction-Associated Steatohepatitis), the most prevalent chronic liver disease for which there is no effective treatments. Please visit www.genflowbio.com and follow the Company on LinkedIn and X.
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