REG - Genflow Biosciences - Company Update

Genflow BiosciencesAnnouncement

04/04/2023 07:00

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RNS Number : 2262V  Genflow Biosciences PLC  04 April 2023

 

4 April 2023

Genflow Biosciences Plc

 

("Genflow" or "the Company")

 

Company Update

The board of Genflow is pleased to provide an update to investors on the
Company's progress during a busy first quarter of 2023.

 

Genflow is the first longevity company listed in Europe, and is well placed to
take advantage of the recent resurgence of interest in the longevity sector
 1 .

 

Group Financial Position

 

The outlook for the Company is positive as it is in a secure financial
position.

 

Genflow's current cash, and grant funding, allows for a 2 year runway until
March 2025 (based on the Company's current, planned expenditure). This puts
Genflow in a more favourable financial position compared to many other
biotechnology companies.

 

Group Update

 

Genflow continues with the research, development and safe implementation of
its two longevity programs:

 

1.     NASH (Non-Alcoholic Steatohepatitis) where the Company is seeking
to reverse ageing fibrotic livers to normal functionality.  NASH affects an
estimated 35 million people globally and is one of the leading causes of
chronic liver disease and liver transplants  2  ; and

 

2.     Werner Syndrome where the Company is seeking to improve the life
of patients with this accelerated ageing disease.  The Company is seeking to
ensure swift first-in-human trials.

 

In furtherance of the Group's programs mentioned above, notable progress
includes:

 

·      The completion of a detailed application dossier for the
Chemistry, Manufacturing, and Controls (CMC) of the Group's medical treatment
of NASH.  This will be presented to the Belgian regulatory authorities
(FAMHP/FAGG) in early June 2023.

 

The Directors believe that this presentation is a significant milestone for
the Group, allowing it direct interaction with national regulatory
authorities, and thus, paving the way for the Group to commence clinical
trials on an accelerated pathway (given there is currently no known medical
treatment for NASH).

 

·      In collaboration with Dr. Manlio Vinciguerra, (a Company
Scientific Advisory Board member based at the University of Liverpool),
Genflow has gained a significantly deeper understanding of the biochemical
changes that occur in the treatment of NASH using its centenarian SIRT6. This
research has led to the Company clearly identifying the workings of its drug
candidate and its potential benefits for NASH patients. As a result, Genflow
has accumulated important data and is currently exploring additional IP
opportunities.

 

As validation, part of these results have been published in a peer controlled
journal (reference: Human centenarian-associated SIRT6 mutants modulate
hepatocyte metabolism and collagen deposition in multilineage hepatic 3D
spheroids - PubMed (nih.gov (https://pubmed.ncbi.nlm.nih.gov/36534275/) )
(https://pubmed.ncbi.nlm.nih.gov/36534275/) ) with the Company's CEO and
members of its Scientific Advisory board listed as co-authors.

 

·      The Company has initiated in-vivo evaluations of its centenarian
SIRT6 gene therapy in four different NASH mice models in conjunction with
three leading partners in the field:

(a)   The University of Liverpool, UK

(b)   The University of Rochester, US; and

(c)   Physiogenex, France (www.physiogenex.com).

 

These studies have been wide reaching and have included the analysation of
over 700 mice, with the intention of understanding the efficacy and safety of
the Company's drug candidate in animal models with NASH.

 

These studies have generated essential information which will be used to seek
authorisation for clinical trials in humans.

 

·      The Company has conducted targeted biodistribution studies of its
SIRT6-AAVs (the means by which gene therapy is delivered to the body) with its
partners IVEX , in Estonia and Articles in Belgium.

 

These studies demonstrate the absorption and distribution of the Company's
drug candidates in the human body. The data from these studies, which is owned
by the Company, will form a significant part of its presentation to the
regulatory authorities mentioned above.

 

·      After conducting rigorous in-house studies, the Company has
achieved consistent and satisfactory delivery of its drug candidate to the
required, targeted human cells, with optimal levels of expression. Referring
to the picture below, investors can see how the Company has developed the
aforementioned consistency and delivery over the period of the studies:

 

 

This significant milestone marks a crucial (and necessary) first step in
determining the most effective dosage for cSIRT6 gene therapy in human trials.

 

·      The Company's partnership with Exogenus Therapeutics in Portugal,
has uncovered a promising opportunity for a new patent application related to
the encapsulation of AAVs into exosomes.  The understanding of the means of
delivery of drug candidates to cells and tissues, whilst reducing the damage
to the human immune system, is key in all areas of medicine.

 

If successful, this-then patent protected delivery method could have
significant positive implications for the field of gene therapy and beyond.
Based on this work, further IP opportunities are also being explored.

 

·      The Group has recently expanded its intellectual property
portfolio through a provisional patent application focussing on the ability to
edit its SIRT6 gene. This gene has been shown to play a role in longevity and
age-related diseases. If successful, the patent will represent a significant
breakthrough in the field of gene editing, with potential implications for
longevity and other forms of gene therapy.

 

The Board looks forward to updating shareholders on further progress in due
course.

 

The information communicated in this announcement is inside information for
the purposes of Article 7 of Regulation 596/2014.

 

Footnotes:

 

 1   How to age well: Can we stay healthy for longer?" - BBC News: Published
on 1 October 2022.

"Could living to 1000 become a reality?" - The Telegraph: Published on 16
February 2021.

"Longevity drugs: Are we getting closer to unlocking the secrets to a longer
life?" - The Independent: Published on 10 August 2022.

"The race for longevity: How scientists are extending our healthy lifespans" -
The Guardian: Published on 12 July 2021.

"Why I believe we will live to 150 within our lifetimes" - Wired UK: Published
on 13 March 2021.

 

 2  Sources: Pais R, Barritt AS 4th, Calmus Y, Scatton O, Runge T, Lebray P,
Poynard T, Ratziu V, Conti F. NAFLD and liver transplantation: Current burden
and expected challenges. J Hepatol. 2016 Dec;65(6):1245-1257. And Vlad Ratziu,
Sven Francque, Arun Sanyal, Breakthroughs in therapies for NASH and remaining
challenges, Journal of Hepatology, Volume 76, Issue 6, 2022)

 

For further information please contact:

 

 Genflow Biosciences Plc
 Dr Eric Leire            +32 477 495 881

 Chief Executive

 Clear Capital Markets
 Corporate Broker         +44 203 869 6080

 

About Genflow Biosciences

 

Genflow is a UK-based biotechnology company established in 2020. The Company
is developing gene therapies designed to target the aging process and to
reduce and delay the incidence of age-related diseases. This will be done
through novel therapeutics targeting aging in humans by using adeno-associated
virus ("AAV") vectors to deliver copies of the Sirtuin-6 ("SIRT6") gene
variant that is found in centenarians into cells.

 

Its mission is to increase our understanding of the factors that control and
impact lifespan. Genflow researches, develops, and commercialises therapeutic
solutions to lengthen health span, the amount of time we live in good health,
creating biological interventions that enable longer and healthier lives.
Genflow is dedicated to the development and commercialisation of novel
therapeutics targeting aging in dogs and humans. By treating aging, Genflow
can contribute to a decrease in healthcare costs and lessen the emotional and
societal burden that comes with an aging population.

 

To learn more visit www.genflowbio.com (http://www.genflowbio.com)

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