Genflow Biosciences PLC Announces Clinical Readiness Acceleration
Genflow Biosciences (OTCQB:GENFF), Europe's only public longevity company, reported progress on two key programs. For GF-1002, the company has initiated CMC work with Exothera for GMP-compliant clinical supply production, while conducting pivotal efficacy studies for MASH treatment through CRO partners Physiogenex and Accelera. This work supports their upcoming European Clinical Trial Authorisation submission.
For GF-1004, Genflow submitted a protocol amendment to their ongoing proof-of-concept trial in aged dogs, specifying IV dose rates for their SIRT6-centenarian gene therapy to enhance safety and delivery consistency. The trial, launched in March with Syngene, aims to evaluate the therapy's impact on age-related decline.
Genflow Biosciences (OTCQB:GENFF), l'unica societ脿 europea pubblica nel settore della longevit脿, ha annunciato progressi su due programmi chiave. Per GF-1002, l'azienda ha avviato i lavori CMC con Exothera per la produzione di forniture cliniche conformi alle norme GMP, mentre sta conducendo studi fondamentali di efficacia per il trattamento MASH tramite i partner CRO Physiogenex e Accelera. Questi studi supportano la prossima richiesta di autorizzazione alla sperimentazione clinica europea.
Per GF-1004, Genflow ha presentato un emendamento al protocollo del loro trial proof-of-concept in corso su cani anziani, specificando le dosi IV per la terapia genica SIRT6-centenaria al fine di migliorare la sicurezza e la coerenza della somministrazione. Il trial, avviato a marzo con Syngene, mira a valutare l'impatto della terapia sul declino legato all'et脿.
Genflow Biosciences (OTCQB:GENFF), la 煤nica compa帽铆a p煤blica europea dedicada a la longevidad, inform贸 avances en dos programas clave. Para GF-1002, la empresa ha iniciado trabajos CMC con Exothera para la producci贸n de suministros cl铆nicos conformes a GMP, mientras realiza estudios de eficacia fundamentales para el tratamiento MASH a trav茅s de sus socios CRO Physiogenex y Accelera. Este trabajo respalda su pr贸xima solicitud de autorizaci贸n para ensayo cl铆nico europeo.
Para GF-1004, Genflow present贸 una enmienda al protocolo de su ensayo de prueba de concepto en perros ancianos, especificando las dosis IV para su terapia g茅nica SIRT6-centenaria con el fin de mejorar la seguridad y la consistencia en la administraci贸n. El ensayo, iniciado en marzo con Syngene, tiene como objetivo evaluar el impacto de la terapia en el deterioro relacionado con la edad.
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GF-1004鞐� 雽�頃� Genflow電� 雲鸽牴瓴潉 雽�靸侅溂搿� 歆勴枆 欷戩澑 臧滊厫 歃濍獏 鞁滍棙鞚� 頂勲韱犾綔 靾橃爼鞎堨潉 鞝滌稖頄堨溂氅�, 鞎堨爠靹标臣 韴棳 鞚缄磤靹膘潉 雴掛澊旮� 鞙勴暣 SIRT6 鞛レ垬 鞙犾爠鞛� 旃橂鞝滌潣 鞝曤Д 韴棳 鞖╇焿鞚� 氇呾嫓頄堨姷雼堧嫟. 3鞗旍棎 Syngene瓿� 頃粯 鞁滌瀾霅� 鞚� 鞁滍棙鞚� 雲疙檾 甏�霠� 靽犿嚧鞐� 雽�頃� 旃橂 須臣毳� 韽夑皜頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�.
Genflow Biosciences (OTCQB:GENFF), la seule entreprise publique europ茅enne sp茅cialis茅e dans la long茅vit茅, a annonc茅 des progr猫s sur deux programmes cl茅s. Pour GF-1002, la soci茅t茅 a lanc茅 les travaux CMC avec Exothera pour la production de fournitures cliniques conformes aux normes GMP, tout en menant des 茅tudes d'efficacit茅 pivot pour le traitement MASH via ses partenaires CRO Physiogenex et Accelera. Ces travaux soutiennent leur prochaine soumission d'autorisation d'essai clinique en Europe.
Pour GF-1004, Genflow a soumis un amendement au protocole de leur essai de preuve de concept en cours chez des chiens 芒g茅s, pr茅cisant les doses IV pour leur th茅rapie g茅nique SIRT6-centenaire afin d'am茅liorer la s茅curit茅 et la constance de l'administration. L'essai, lanc茅 en mars avec Syngene, vise 脿 茅valuer l'impact de la th茅rapie sur le d茅clin li茅 脿 l'芒ge.
Genflow Biosciences (OTCQB:GENFF), Europas einziges b枚rsennotiertes Longevity-Unternehmen, meldete Fortschritte bei zwei wichtigen Programmen. 贵眉谤 GF-1002 hat das Unternehmen die CMC-Arbeiten mit Exothera zur GMP-konformen Herstellung klinischer Versorgung gestartet und f眉hrt gleichzeitig entscheidende Wirksamkeitsstudien zur MASH-Behandlung 眉ber die CRO-Partner Physiogenex und Accelera durch. Diese Arbeiten unterst眉tzen die bevorstehende Einreichung der Europ盲ischen Klinischen Studiengenehmigung.
贵眉谤 GF-1004 reichte Genflow eine Protokoll盲nderung f眉r ihre laufende Proof-of-Concept-Studie bei 盲lteren Hunden ein, in der intraven枚se Dosierungsraten f眉r ihre SIRT6-Centenarian-Gen-Therapie zur Verbesserung von Sicherheit und Lieferkonsistenz festgelegt werden. Die im M盲rz zusammen mit Syngene gestartete Studie zielt darauf ab, die Auswirkungen der Therapie auf altersbedingten Abbau zu bewerten.
- None.
- Both lead programs still in early development stages
- Protocol amendment requirement suggests initial delivery challenges in dog trials
Clinical Readiness Accelerates Across Genflow Biosciences Lead Programs
LONDON, UK / / July 24, 2025 / Genflow Biosciences Plc (LSE:GENF)(OTCQB:GENFF) ("Genflow" or "the Company"), the only publicly listed longevity company in Europe, is pleased to report key preclinical activities in two of its lead programs.
GF-1002
In preparation for a submission for European Clinical Trial Authorisation (CTA), the EU's regulatory equivalent to the U.S. FDA's IND process, Genflow is continuing to advance key development activities. To support this process, the Company has initiated Chemistry, Manufacturing, and Controls (CMC) work in collaboration with its CDMO partner, Exothera, to ensure clinical supply production meets Good Manufacturing Practice (GMP) standards. In parallel, pivotal efficacy studies are underway with Genflow's independent CRO partners, Physiogenex and Accelera, evaluating GF-1002 in both early and advanced stages of MASH.
GF-1004
Genflow has submitted a first protocol amendment to its ongoing proof-of-concept clinical trial in aged dogs to clarify the administration of its investigational product, GF-1004. The amended protocol now specifies the intravenous (IV) dose rate to ensure consistent and controlled delivery, minimizing the risk of infusion-related adverse events and reinforcing patient safety. This randomized, controlled trial initiated in March in collaboration with the renowned CRO, Syngene is designed to evaluate the safety and efficacy of Genflow's proprietary SIRT6-centenarian gene therapy in addressing age-related decline in dogs.
Dr. Eric Leire, CEO of Genflow, commented: "This update reflects the growing maturity of our pipeline and our continued commitment to advancing science-backed therapies in healthy aging. The combination of expected non-dilutive funding, strategic partnerships, and supportive regulatory tailwinds puts Genflow in a strong position to accelerate both our programs."
Contacts
Genflow Biosciences | Harbor Access |
Dr Eric Leire, CEO | Jonathan Paterson, Investor Relations |
+32-477-495-881 | +1 475 477 9401 |
Corporate Broker | |
Capital Plus Partners | |
Jonathan Critchley | |
+44 0207 432 0501 |
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 and follow the Company on and .
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SOURCE: Genflow Biosciences PLC
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