Genflow Biosciences Share Discussion Threads

[moneymunch] 05/12/2024 07:17

"Multiple key clinical and regulatory milestones expected in next 18 months

Undervalued stock opportunity; Potential acquisition by pharmaceutical partner"

[moneymunch] 04/12/2024 15:23

LSE: GENF - OTCQB: GENFF


WHO WE ARE

Pioneering Novel Gene Therapeutics for a Longer, Healthier Life

MISSION: aging is underlying risk factor for disease, and our aim is to deliver
gene therapeutics that potentially halt or slow the aging process in humans and dogs

SIRT6 GENE: longevity protein that widely regulates aging and immunity and
is a potential therapeutic target for the treatment of diseases

PROMISING PRECLINICAL RESULTS: lead drug candidate GF-1002 delivers
a centenarian variant of the SIRT6 gene for treatment of MASH

SEASONED TEAM: experienced and proven management with extensive
experience in public & private pharma and biotech

ROBUST PIPELINE: advancing multiple development programs
over 24 months: MASH, Sarcopenia, Werner and life extension of dogs

SIRT6: REPAIRING DNA

SIRT6 gene/protein repairs DNA damage (especially double strand breaks (DSB)) and prevents senescence of our cells

SIRT6 gene codes for SIRT6 protein

Stronger SIRT6: Longer lifespan

The Ability of SIRT6 to stimulate DSB repair corelates with maximum lifespan (MLS) in rodents

5 Amino Acids determine the differential activities of SIRT6

FOCUS ON CENTENARIAN SIRT6

SIRT6 centenarian variant gene has more efficient DNA repair properties

MASH PROGRAM

Affects est. 35 million people globally

• Increasing prevalence
• Leading cause of chronic liver disease and liver transplant

Significant unmet medical need

Clear regulatory accelerated development pathway.

EMA and FDA guidelines accept:

✓ Key surrogate outcomes for therapeutic trials: regression of fibrosis or resolution of NASH

✓ Histological changes are achievable within a 12-18-month time-frame

✓ Placebo control

✓ Conditional fast-track approval

EXOSOME DELIVERY SYSTEM: SAFE AND COST-EFFECTIVE

Genflow’s patent-pending technology has already been tested in several preclinical studies

ADVANTAGES: EXOSOME DELIVERY

Exo-AAV can mediate efficient, specific, and more durable SIRT6 expression in liver compared to conventional AAV

2023 KEY HIGHLIGHTS & 2024 PRIORITIES

GROWING IP PORTFOLIO

Provisional patent application in 2023 for editing SIRT6 gene, linked to longevity
and age-related diseases

EXPANDED MARKET

Awarded to new grants in 2023 & 2024 expanding research pipeline and size of
therapeutic markets

GF-1002
Undertaking key Investigational New Drug (IND) -enabling development activities
to help define pharmacological and toxicological properties and potential benefit
to NASH patients

GF-1003
Commencing preliminary discussions with the European Medicines Agency (EMA)
on Mechanism of Action (MoA) data for Orphan Drug Application (ODA) targeting
Werner Syndrome


2023 KEY HIGHLIGHTS & 2024 PRIORITIES

LARGE MARKET OPPORTUNITY

NASH: 35 Million globally. Increasing prevalence. Door opener to even broader anti-aging indication

LONG LIFE IP

2 patent families SIRT6 centenarian and gene delivery (entering National Phase); Additional upcoming patent applications (entering PCT)

GENE DELIVERY SYSTEMS

Proprietary innovative gene delivery systems: exo-AAV, mRNA exosomes, LNPs Centenarian variant of SIRT6 gene

GF-1002 and GF-1003
Multiple key clinical and regulatory milestones expected in next 18 months
Undervalued stock opportunity; Potential acquisition by pharmaceutical partner

[moneymunch] 04/12/2024 15:06

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)

1,781 followers
2h

Check out Genflow Biosciences (LON:GENF) (OTCQB:GENFF) latest presentation! Learn about #GENF's impressive financials, recent milestones in its #SIRT6 studies, and exciting future plans.

See it here:

#biotech #MASH #WernerSyndrome #Sarcopenia #aging

[moneymunch] 03/12/2024 18:42

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)
1,782 followers

1h

🧬 The rise of exosome-based therapeutics has caused quite a stir in the #biotechnology field. 🧬

Earlier this year, BioSpace spotlighted the growing potential of the therapies. Recognized as a leader in the field, they turned to Genflow Biosciences (LON:GENF) (OTCQB:GENFF) CEO Dr. Eric Leire for his insights.

👀 Read what he had to say here:

#GENF #GENFF


Exosome Therapeutics Are Paving a Path to Clinical Readiness
biospace.com

[moneymunch] 03/12/2024 07:21

24/10/24

Roche, Dyno Launch $1B+ AAV Gene Therapy Vector Collaboration

Roche will apply Dyno Therapeutics’ engineered adeno-associated virus (AAV) capsid platform to develop next-generation AAV vectors for gene therapies targeting unspecified neurological diseases, through a collaboration that could generate more than $1 billion for Dyno.

The collaboration—the second for the companies—is designed to provide Roche with further access to Dyno’s platform and sequence design technologies enabling in vivo gene delivery.

Dyno and Roche launched their first collaboration in 2020, when they inked a research collaboration and license agreement for a potentially more-than-$1.8 billion partnership to develop next-generation AAV vectors for neurological disease and liver-directed gene therapies.

[moneymunch] 02/12/2024 20:59

ExoXpert will also be able to be the first CDMO internationally to offer exosome specialized GMP capabilities to its current client portfolio in both US and EU markets as well as future partners. ExoXpert can activate additional clean room on demand.

The GMP certification to be awarded to a specialist exosome CDMO is a significant international achievement. It allows EXO Biologics & ExoXpert to support across the industry clinical trials and regulatory submissions for the growing number of exosome-based products and services internationally. Currently, the greatest demand is for the use of exosome as safe and non-viral drug delivery system for cell & gene therapy applications.

Successful Loading of mRNA and DNA Payloads into GMP-Grade Exosomes
In addition to the production site certification, EXO Biologics and ExoXpert have successfully completed loading a number of chemical molecules and nucleic acids into exosomes from various cell sources. This breakthrough represents a critical step toward developing safe, efficient, and scalable exosome-based therapies for genetic material delivery.

Small molecules and short nucleic acids (siRNA and miRNA) have already been validated in an end-to-end GMP-like setting. Now EXO Biologics has made significant progress in loading larger molecules, such as mRNA and DNA, into GMP-grade exosomes for third-party non-viral drug delivery applications. Preliminary data from EXO Biologics’ trials show a retention rate up to 80% of the loaded DNA cargo upon exosome loading.

EXO Biologics and ExoXpert are now working together on optimization and GMP translation of this new unit operation to provide a seamless platform toward clinical application. The loading step is to be incorporated in ExoXpert’s cutting edge ExoPulse™ exosome manufacturing GMP platform. ExoPulse is currently being used by several partners to develop exosome-based product with a derisked path to clinical.

[moneymunch] 02/12/2024 20:52

Genflow

· Exosome-mRNA project with EXO Biologics - which aims to deliver a therapeutic product composed of exosomes encapsulating an AAV or mRNA encoding SIRT6. The exosome therapy will be designed to target liver fibrosis (MASH) and Werner Syndrome, potentially leading to groundbreaking treatments for both diseases.

[moneymunch] 02/12/2024 20:46

EXO Biologics & ExoXpert achieve two critical industry-first milestones for the exosome field

• First GMP certification of European exosome-specialist manufacturing facility

• Successful loading of mRNA and DNA payloads into GMP-grade exosomes for third-party non-viral drug delivery services

Liège, Belgium, December 2, 2024

– EXO Biologics and its CDMO subsidiary, ExoXpert, leading innovators in exosome-based therapeutics and drug delivery solutions, today announce ExoXpert is the first European CDMO specializing in exosomes to receive Good Manufacturing Practice (GMP) certification for its state of the art manufacturing plant.

In addition, EXO Biologics has managed to achieve the loading of GMP-grade exosomes with mRNA and DNA payloads, a major milestone for the development of exosome-based therapies.

These achievements are two significant milestones that will further solidify EXO Biologics’ position at the forefront of the maturing exosome field.

GMP Certification of Clean Rooms in Liège, Belgium
ExoXpert is the first European exosome specialist CDMO to receive Good Manufacturing Practice (GMP) certification.

The certification is for its exosome manufacturing plant in Liège, Belgium and has been awarded by the Belgian federal agency for medicines and health products.

The growth of EXO Biologics and ExoXpert has been strongly supported by BioWin (the health cluster of Wallonia) and SPW (Wallonia Public Service).

[moneymunch] 01/12/2024 14:14

A very exciting year ahead for Genflow and all invested, and plenty of positive newsflow in the pipeline including the following. Gla holders :-)

14th October 2024

"There's a very large appetite from the veterinary industry for life extension for our dog companions. Therefore, we'll provide proof of concept. We're starting this very soon, and once this proof of concept is finished, that should trigger an out-licensing deal with our partner in veterinary. "

[marmiesz] 01/12/2024 10:30

PS.Last week quotes ended up 1.565 v 1.585

[marmiesz] 01/12/2024 10:28

Trading pattern has been narrowed recently and I feel that this could break one way or another soon. It could be that the patent confirmation will trigger a positive move as this is due to be announced any time in the next weeks or months. Happy to keep adding as I have been over the last few weeks. Holding for long term as I'm an investor not a trader,Marmie

[moneymunch] 28/11/2024 20:03

Genflow's academic partners at Rochester, Harvard and Einstein College, well funded for the next 5 years and perhaps beneficial to Eric & Co. Gla :-)

Comparing gene sequences across species to understand aging and dementia

October 16, 2024

A new grant partners longevity researchers and Alzheimer’s experts at Rochester to study the gene mechanisms that contribute to long and healthy lifespans.
.....
Recognizing the research potential of this partnership, the National Institute on Aging (NIA), part of the National Institutes of Health, recently awarded Gorbunova, O’Banion, and their team of researchers a five-year grant of $18.5 million to study the comparative genomics of longevity and Alzheimer’s disease. The grant, which is headed by Gorbunova, also includes Rochester faculty members Andrei Seluanov and Hongbo Liu, along with colleagues at Harvard University, Einstein College of Medicine, Washington University, and Mount Sinai’s Icahn School of Medicine.

[moneymunch] 28/11/2024 07:15

Former SENS Research Foundation CEO set to bring longevity expertise to pivotal health position as deputy secretary of HHS Department.

Jim O’Neill, a prominent figure in longevity biotechnology and regenerative medicine, has been nominated by US president-elect Donald Trump to serve as Deputy Secretary of Health and Human Services (HHS). It is an announcement has sparked interest across scientific and policy circles, given O’Neill’s extensive experience in longevity research and his leadership roles within pioneering health organizations, and one that comes in the same month that Trump revealed his nominees for Health Secretary and FDA Commissioner are Robert F Kennedy Jr and Dr Martin Makary, respectively.

O’Neill’s professional background includes serving as CEO of the SENS Research Foundation (SRF), an organization dedicated to combating age-related diseases through regenerative medicine. Under his leadership, SRF led efforts to research and develop therapeutic solutions for Alzheimer’s, cancer and heart disease, and, according to a statement on the platform Truth Social, O’Neill led “progress toward rejuvenating the immune system, eliminating senescent cells, rejuvenating the neocortex, and obviating mitochondrial mutation.”

Longevity.Technology: O’Neill’s nomination signals an intriguing intersection between regulatory leadership and scientific innovation, raising questions about the evolving role of the FDA and other agencies in addressing aging as a critical health challenge. O’Neill’s nomination may herald a shift in the approach to aging and age-related diseases within the federal health agenda. While the FDA has not formally recognized aging as a treatable condition, this nomination could signify an openness to integrating age-focused therapeutics into broader public health strategies; such a perspective would align with global trends, as countries increasingly explore aging-related healthcare policies to address the demands of an aging population.

The longevity sector has long grappled with regulatory challenges, particularly around clinical trials for therapies targeting aging mechanisms rather than specific diseases. O’Neill’s previous involvement with SRF and his broader industry connections suggest he could bring a more nuanced understanding to these issues, potentially fostering a regulatory environment conducive to longevity-focused innovations.

[moneymunch] 22/11/2024 09:53

Looking forward to a run of positive newsflow and a potential Stellar and transformational 2025 year ahead as Genflow's cutting edge science and R&D, makes planned progress towards human and dog clinical trials, with the real prospect of an early move by a Major Pharma JV partner or two!!! Exciting times for all invested. Gl.:-)

[moneymunch] 22/11/2024 07:54

News on approvals for patents pending coming soon, given the average time of 25.9 months from filing date...Gla holders :-)

[moneymunch] 22/11/2024 07:50

WO/2022/241228VARIANTS OF SIRT6 FOR USE IN PREVENTING AND/OR TREATING AGE-RELATED DISEASES

WO - 17.11.2022

Int.Class
C12N 15/113
Appl.No PCT/US2022/029213
Applicant UNIVERSITY OF ROCHESTER
Inventor GORBUNOVA, Vera
The present invention relates to an isolated nucleic acid molecule encoding a variant of sirtuin 6 (SIRT6) having at least 75% identity with sequence SEQ ID NO: 1, the variant having at least one mutation selected in the group comprising or consisting of a N308K substitution and a A313S substitution with respect to sequence SEQ ID NO: 1. The invention provides means for the regulation of ageing, and/or senescence, and/or lifespan in an individual. The invention further provides means for the repair of double strand breaks in a cell. Finally, the invention also provides means for the prevention and/or the treatment of an age-related disease.


21 March 2024



Genflow Biosciences Plc

Announces Publication of a Key European Patent in Partnership with University of Rochester, New York, et al.



Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF) ("Genflow" or "the Company"), an emerging leader in the field of longevity research, focused on developing therapeutic solutions for the prevention of age-related diseases, is pleased to announce a significant milestone in its journey. Genflow's collaborative partners, including the University of Rochester, The Trustees of Columbia University in the City of New York, and Albert Einstein College of Medicine, have received confirmation that their European patent application was published today by the European Patent Office, bearing the reference number EP 4 338 267.

[moneymunch] 22/11/2024 07:36

Variants of sirtuin 6 for the treatment of non-alcoholic fatty liver disease

Abstract

The present invention relates to variants of sirtuin 6 for the treatment of non-alcoholic fatty liver disease.
Classifications
A61K38/43 Enzymes; Proenzymes; Derivatives thereof

WO2024121363A1
WIPO (PCT)


Inventor Manlio Vinciguerra Eric Leire
Worldwide applications
2023 WO
Application PCT/EP2023/084840 events
2023-12-08
Application filed by Genflow Biosciences Srl
2024-06-13
Publication of WO2024121363A1

[moneymunch] 22/11/2024 07:31

Patents Assigned to GENFLOW BIOSCIENCES SRL

METHOD OF IN VIVO ADMINISTRATION OF THE CODING SEQUENCE OF THE SIRT6 GENE VIA ADENO-ASSOCIATED VIRUS

Publication number: 20230018934
Abstract: Methods for in vivo administration of the coding sequence of the sirt6 gene. In particular, methods that include the administration of adeno-associated virus vectors or recombinant adeno-associated virus vectors including the coding sequence of the sirt6 gene.
Type: Application
Filed: July 15, 2022
Publication date: January 19, 2023
Applicant: GENFLOW BIOSCIENCES SRL
Inventor: Eric LEIRE

[moneymunch] 22/11/2024 07:26

Time
The average time a patent application is pending is about 25.9 months. Most pending patent applications are published in a journal or periodical 18 months after the filing date.

[moneymunch] 21/11/2024 17:13

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)
1,776 followers

4h

In #biotech, safety is absolutely paramount. At Genflow Biosciences (LON:GENF) (OTCQB:GENFF), we are committed to elevating safety measures across our pioneering #SIRT6 trials.

All of our #SIRT6 trials use patent pending tech to safely and temporarily activate the SIRT6 gene to maximize benefits. This allows us to gauge the effectiveness of compound while keeping risks to a minimum.

Discover more about our approach:

[m_night10] 20/11/2024 13:52

Will rush to 3-4p again on any news. Has frequently gone to 3p on nothing.

[moneymunch] 17/11/2024 19:28

Perfectly poised and primed for a significant move North imho, more good news from Eric at anytime!!! Gla :-)

[moneymunch] 14/11/2024 07:14

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)

1,769 followers
18h

With a growing population over 65, healthcare costs are climbing, making aging not just a societal challenge but a significant economic one. Genflow Biosciences (LON:GENF) (OTCQB:GENFF) is taking action to reduce this burden through focused research and innovation.

#Genflow Highlights:
✅ Groundbreaking work on the #SIRT6 gene’s centenarian variant
✅ Development of new treatments addressing multiple health conditions
✅ A Scientific Advisory Board comprised of leading experts

Discover our more about our work:

#GENF #GENFF #aging

[moneymunch] 12/11/2024 15:23

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)’s Post

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)
1,767 followers

1d

🧬 Why Genflow Biosciences (LON:GENF) (OTCQB:GENFF)? 🧬

Genflow Biosciences offers investors a unique opportunity to support a #biotech company revolutionizing the #longevity field. Our innovative #SIRT6 work has led to recent attention, including being named "A Firm to Watch" by The Guardian.

Learn more about #Genflow's investment story:

#GENF #GENFF #invest #smallcap