Genflow Biosciences PLC Enhances Pre-Clinical Efforts

Genflow Biosciences Plc, a pioneering company in the field of longevity research, has announced significant progress in its pre-clinical programs aimed at developing therapeutic solutions to prevent age-related diseases. The company, listed on the London Stock Exchange and the OTCQB, revealed its latest advancements on June 27, 2024.

A key development is the initiation of a feasibility study with Exothera S.A., a Contract Development Manufacturing Organization (CDMO). This study will assess the production capabilities for Genflow's future MASH clinical lot, ensuring compliance with Good Manufacturing Practices (GMP). This step is crucial for the company as it lays the groundwork for future clinical trials.

Simultaneously, Genflow is in the process of selecting Contract Research Organizations (CROs) to conduct its upcoming clinical trial involving dogs. The trial will evaluate the effectiveness of Genflow's drug candidate, GF-1004. The company is currently reviewing proposals and aims to finalize agreements next month, moving closer to the trial's commencement.

In addition to these strategic collaborations, Genflow has received valuable research guidance from the U.S. Food and Drug Administration (FDA) through its Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) program. Genflow submitted a detailed briefing package that included all preclinical studies conducted with its lead drug candidate, GF-1002, intended for the treatment of Metabolic Associated Steatohepatitis (MASH).

The FDA's feedback has been encouraging, advising Genflow to proceed with identifying suitable animal models through pilot proof-of-concept (POC) studies. These initial studies will help inform more definitive POC, toxicology, and biodistribution studies, which are vital for advancing to human clinical trials. The FDA emphasized the importance of including detailed summaries of the products used in each animal study and their comparability to the intended clinical product.

Dr. Eric Leire, CEO of Genflow, expressed his enthusiasm about the company's progress: "We are excited by the momentum we have built in moving forward with our pre-clinical programs and the guidance received from the FDA. This encouragement reinforces our commitment to developing effective therapeutic solutions for age-related diseases. As we move forward with our dog clinical trials, we remain focused on our mission to improve healthspan."

Founded in 2020, Genflow Biosciences is a biotechnology company based in the UK with research and development facilities in Belgium. The company is at the forefront of developing gene therapies aimed at slowing down the aging process, with the ultimate goal of extending healthy and active years of life. The lead compound, GF-1002, delivers a centenarian variant of the SIRT6 gene, showing promising preclinical results. Genflow plans to initiate clinical trials in 2025 to explore GF-1002's potential in treating MASH, a prevalent chronic liver disease currently lacking effective treatments.

In summary, Genflow Biosciences is making significant strides in its pre-clinical programs, fortified by strategic collaborations and valuable FDA guidance. With a clear path forward, the company is well-positioned to advance its mission of combating age-related diseases and enhancing healthspan.

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