Potential Newsflow22 Jul 2023 09:19
Plenty of potential material newsflow to add significant UPSIDE at anytime. Gla :-)
Genflow Biosciences PLC (LSE:GENF), Europe's first listed longevity company, said it made significant progress during a 'busy' first quarter of 2023.
In the update, it also said it was in a secure financial position with enough cash and grant funding to last until March 2025.
Investors were also told it continued to make headway in two groundbreaking longevity programs: Non-alcoholic steatohepatitis (NASH) and a form of premature ageing called Werner Syndrome.
Genflow said it had reached several milestones, including the completion of a detailed application dossier for the chemistry, manufacturing, and controls (CMC) of its NASH treatment.
It will present the dossier to the Belgian regulatory authorities in early June, paving the way for accelerated clinical trials as there is currently no known medical treatment for NASH.
In collaboration with Dr Manlio Vinciguerra at the University of Liverpool, the drug developer said it has achieved a deeper understanding of the biochemical changes in NASH treatment using its centenarian SIRT6.
The research findings have been published in a peer-reviewed journal, and Genflow is exploring additional intellectual property (IP) opportunities.
It has also initiated in-vivo evaluations of its centenarian SIRT6 gene therapy in four different NASH mice models in partnership with the University of Liverpool, the University of Rochester, and the clinical research group, Physiogenex.
The studies, which have analysed over 700 mice, aim to understand the efficacy and safety of the drug candidate in animal models with NASH. The results will be crucial for seeking authorisation for clinical trials in humans.
Additionally, the company has conducted targeted biodistribution studies of its SIRT6-AAVs with partners IVEX in Estonia and Articles in Belgium. The data will form a significant part of its presentation to the regulatory authorities.
After rigorous in-house studies, Genflow has achieved consistent and satisfactory drug candidate delivery to targeted human cells, marking a crucial first step in determining the most effective dosage for cSIRT6 gene therapy in human trials.
Genflow's partnership with Exogenus Therapeutics in Portugal has led to a promising opportunity for a new patent application related to the encapsulation of AAVs into exosomes. If successful, the patent-protected delivery method could have significant positive implications for gene therapy.
Furthermore, the company has expanded its intellectual property portfolio through a provisional patent application focusing on editing its SIRT6 gene, which plays a role in longevity and age-related diseases.
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