RCS - Genflow Biosciences - Corporate Update

Genflow BiosciencesAnnouncement

Yesterday 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250617:nRSQ7719Ma&default-theme=true

RNS Number : 7719M  Genflow Biosciences PLC  17 June 2025

 

17 June 2025

 

Genflow Biosciences Plc

 

Genflow Biosciences Provides Half Year Corporate Update on SIRT6 Programs, IP
Progress and Strategic Partnerships

 

Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF) ("Genflow" or "the Company"),
the only publicly listed longevity company in Europe, is pleased to provide an
update on the continued advancement of its core programs focused on the
SIRT6-centenarian gene and its potential to slow aging and delay the onset of
age-related diseases.

 

Since the start of the year, the Company has made meaningful progress across
its research and development initiatives. These advancements have been
supported by a strengthened leadership network of world-class academic
collaborators and laboratories. Combined with the continued support of
international institutional investors and previously awarded government
grants, this ecosystem has played a vital role in accelerating Genflow's
scientific and clinical development.

 

As part of its strategic execution, Genflow has signed a Master Service
Agreement (MSA) with CER Groupe, a trusted long-term partner and leading
Belgian research center specializing in integrated bioproduction and
pre-clinical services. CER operates in a fully regulated ISO and GxP-compliant
environment and will provide a robust R&D framework to support the
advancement of Genflow's pre-IND gene therapy programs.

 

In parallel, the Company continues to expand its global intellectual property
portfolio. In February, Genflow's exclusively out-licensed European Patent
Office (EPO) application titled "Variants of SIRT6 for Use in Preventing
and/or Treating Age-Related Diseases" advanced through the Supplementary
European Search Report without objections, allowing it to proceed to the
national phase-a key step toward securing protections across major European
markets.

 

Similarly, the Japanese Patent Office has progressed the same SIRT6-related
application (Application No. JP 2024515284) to the national examination phase,
marking another important milestone in establishing global IP coverage for
Genflow's innovative gene therapy technology.

 

Originally filed on 13 May 2022, the patent is jointly owned by the University
of Rochester, The Trustees of Columbia University in the City of New York, and
Albert Einstein College of Medicine. Genflow holds the exclusive worldwide
license to this intellectual property.

 

To support the intellectual property costs associated with entering into the
national phase in the U.S., Canada, Europe, Japan, Australia, China, Genflow
has applied for a PATEX-2 grant in connection with its patent application
PCT/EP2023/084840, titled "SIRT6 Variants for NASH," filed on December 8,
2023. This patent is fully owned by Genflow Biosciences.

 

Below is a status update on each of our programs, reflecting significant
progress at the mid-year point:

 

MASH (GF-1002): We completed an initial production test with our CDMO partner,
Exothera SA, for the GMP manufacturing of GF-1002. The results exceeded our
expectations, with a yield notably higher than anticipated-a promising outcome
for the upcoming manufacturing phases.

 

We are currently conducting the two pivotal studies to support our filing for
Clinical Trial Application (CTA) for GF-1002 in MASH. These studies are being
carried out independently by two reputable Contract Research Organizations
(CROs): Physiogenex and Accelera.

 

Genflow signed an MSA with Heureka Labs, a medical AI company spin-off from
Duke University. Heureka will provide Genflow with access to its proprietary
artificial intelligence ("AI") platform, which specializes in the analysis of
high-dimensional genomic data including RNA sequencing and gene expression
profiles. The application of Heureka's AI technology is expected to enhance
Genflow's ability to interpret complex biological datasets, enabling deeper
insights into gene regulatory networks and systemic biological responses.
These insights will be key to optimising therapeutic design and anticipating
patient-specific outcomes. Genflow will retain all IP rights under the
agreement. Our MASH program receives support through a research grant awarded
by the regional government of Wallonia - Belgium Service Public de Wallonie.

 

Werner Syndrome (GF-1003): We have developed a proprietary liver organoid
model derived from human cells of patients with Werner syndrome. This
innovative system allows us to test our drug candidate, GF-1003, directly in a
disease-relevant human tissue model. The approach offers several advantages:
it reduces the need for animal testing and provides deeper insight into the
efficacy and safety of GF-1003 in a synthetic organ created from the cells of
three Werner syndrome patients. As a result, this model significantly enhances
the predictive value of our preclinical data for the potential success of
future clinical trials in Werner patients.

 

The use of more sophisticated organoid models reflects Genflow's strong
commitment to minimizing animal suffering wherever possible. While this
approach involves higher costs and longer development timelines, it aligns
with our core values and ethical commitment to respecting animal welfare. By
prioritizing human-relevant, non-animal models, Genflow demonstrates that
scientific progress and compassion can go hand in hand.

 

Our Werner program receives support through a research grant awarded by the
regional government of Wallonia.

 

Dog Aging (GF-1004): In March, we commenced a proof-of-concept clinical trial
to evaluate the safety and efficacy of its proprietary SIRT6-centenarian gene
therapy targeting age-related decline in dogs. The Company is treating the
dogs for 6 months and assess the safety and efficacy of our therapy for the
following 6 months. This is a randomized, controlled trial with 28 dogs aged
10+ years, conducted with the renowned CRO, Syngene.  Genflow will compare
recipient dogs of intravenous injections of proprietary SIRT6 gene therapy
versus untreated control group.  Endpoints will include biological age
estimation (via GRIM methylation clock), muscle strength, muscle mass,
mitochondrial function, coat quality and overall health indicators.

 

Sarcopenia (GF-1005): Our sarcopenia program, aimed at combating age-related
muscle loss, continues to progress positively with GF-1005-myoblast progenitor
cells engineered to express the centenarian variant of SIRT6 (centSIRT6). This
project is being carried out in collaboration with our partners at Université
libre de Bruxelles (ULB) and Revatis.

 

Building on this foundation, Genflow has identified three additional sirtuin
genes that may act synergistically with centSIRT6. This has led to the
development of four drug candidates: GF-10051, which expresses centSIRT6
alone, and GF-10052, GF-10053, and GF-10054, each co-expressing centSIRT6 with
one of the three potentially synergistic sirtuin genes. We have successfully
achieved stable dual gene expression-a technically challenging feat due to the
large size of the combined genetic constructs. This milestone highlights
Genflow's advanced capabilities in gene therapy development.

We are now fine-tuning functional assays, with a particular focus on
mitochondrial function, to further evaluate the therapeutic potential of these
candidates.

 

Our sarcopenia program receives support through a research grant awarded by
the regional government of Wallonia.

 

 

Ophthalmology: Genflow launched a new development program in ophthalmology,
focused on advancing a novel gene therapy leveraging its proprietary
centenarian SIRT6 (centSIRT6). This therapy will utilize a specially designed
non-viral vector engineered for precise delivery of Genflow's centSIRT6 to
different compartments of the eye. The therapy is designed to combat ocular
problems including several pathologies of the cornea and glaucoma. This
initiative is part of Genflow's continued efforts to optimize its gene therapy
and proprietary centenarian SIRT6.

 

As part of this effort, Genflow has signed a Material Transfer Agreement (MTA)
with a leading ophthalmology company, to collaborate on the design and
development of the eye-targeted centSIRT6 non-viral vector to target ocular
diseases. These therapies will leverage Genflow's proprietary centSIRT6
Centenarian gene technology, in combination with an advanced vector delivery
system.

 

Guided by our mission to improve healthspan, updates will be provided on our
current programs, such as the clinical dog trials, as they progress.

 

Contacts

 Genflow Biosciences  Harbor Access
 Dr Eric Leire, CEO   Jonathan Paterson, Investor Relations
 +32-477-495-881      +1 475 477 9401
                      Jonathan.Paterson@Harbor-access.com

 

 Corporate Brokers
 Capital Plus Partners Ltd
 Jon Critchley, +44 0203 821 6168

 

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 (http://www.genflowbio.com)   and follow the Company on
LinkedIn
(https://www.linkedin.com/company/genflow-biosciences/?viewAsMember=true) and
X (https://x.com/genflowbio) .

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAVXLBFEQLLBBF