SOHM Notes FDA's Evolving Gene-Editing Framework in Context of Ongoing ABBIE Platform Development
SOHM (OTCID:SHMN) acknowledged recent FDA commentary and industry analyses noting an evolving regulatory framework for genome‑editing technologies on November 4, 2025. The company said regulators are increasingly focused on precision-engineered tools, non-viral delivery methods, and scalable manufacturing.
SOHM is advancing its proprietary ABBIE genome‑engineering platform in preclinical development; ABBIE is described as a programmable enzyme architecture designed to enable DNA‑insertion events without viral vectors. Management emphasized ongoing preclinical work on safety, mechanism, and reproducibility.
SOHM (OTCID:SHMN) ha riconosciuto i recenti commenti della FDA e analisi del settore che indicano un quadro normativo in evoluzione per le tecnologie di modifica genetica il 4 novembre 2025. L'azienda ha detto che i regolatori si concentrano sempre di più su strumenti programmabili di precisione, sulle metodi di consegna non virali e sulla produzione scalabile.
SOHM sta avanzando con la sua piattaforma proprietaria di ingegneria genetica ABBIE in sviluppo preclinico; ABBIE è descritta come un'architettura di enzimi programmabili progettata per permettere eventi di inserimento del DNA senza vettori virali. La dirigenza ha sottolineato il lavoro preclinico in corso su sicurezza, meccanismo e riproducibilità.
SOHM (OTCID:SHMN) reconoció comentarios recientes de la FDA y análisis de la industria que señalan un marco regulatorio en evolución para las tecnologías de edición genómica en el 4 de noviembre de 2025. La empresa indicó que los reguladores se centran cada vez más en herramientas de precisión diseñadas, entrega no viral y fabricación escalable.
SOHM avanza con su plataforma propietaria de ingeniería del genoma ABBIE en desarrollo preclínico; ABBIE se describe como una arquitectura de enzimas programables diseñada para permitir eventos de inserción de ADN sin vectores virales. La dirección enfatizó el trabajo preclínico continuo sobre seguridad, mecanismo y reproducibilidad.
SOHM (OTCID:SHMN)은 2025년 11월 4일에 FDA의 최근 논평 및 업계 분석에서 유전체 편집 기술에 대한 규제 체계가 진화하고 있음을 인정했다. 회사는 규제 당국이 점점 더 정밀하게 설계된 도구, 비바이러스 전달 방법, 그리고 확장 가능한 제조에 집중하고 있다고 말했다.
SOHM은 독점적인 ABBIE 유전체 공학 플랫폼을 전임상 개발 중이며; ABBIE는 바이럴 벡터 없이 DNA 삽입 이벤트를 가능하게 하는 프로그래머블 효소 아키텍처로 설명된다. 경영진은 안전성, 기전 및 재현성에 대한 전임상 연구가 계속 진행 중임을 강조했다.
SOHM (OTCID:SHMN) a reconnu les récents commentaires de la FDA et les analyses de l'industrie soulignant un cadre réglementaire en évolution pour les technologies d'édition du génome le 4 novembre 2025. L'entreprise a déclaré que les régulateurs se concentrent de plus en plus sur des outils de précision conçus, la délivrance non virale et une fabrication évolutive.
SOHM fait progresser sa plateforme propriétaire d'ingénierie du génome ABBIE en développement préclinique; ABBIE est décrite comme une architecture d'enzymes programmables conçue pour permettre des événements d'insertion d'ADN sans vecteurs viraux. La direction a souligné les travaux précliniques en cours sur la sécurité, le mécanisme et la reproductibilité.
SOHM (OTCID:SHMN) hat jüngste FDA-Kommentare und Branchenanalysen anerkannt, die auf einen sich entwickelnden regulatorischen Rahmen für Genome-Editierungs-Technologien am 4. November 2025 hinweisen. Das Unternehmen sagte, dass Regulierungsbehörden sich zunehmend auf präzisionsgeplante Werkzeuge, nicht-virale Liefermethoden und skalierbare Herstellung konzentrieren.
SOHM treibt seine firmeneigene ABBIE-Plattform zur Genom-Engineering in der präklinischen Entwicklung voran; ABBIE wird als programmierbare Enzymarchitektur beschrieben, die DNA-Insertions-Ereignisse ohne virale Vektoren ermöglicht. Das Management hob die laufende präklinische Arbeit zu Sicherheit, Mechanismus und Reproduzierbarkeit hervor.
SOHM (OTCID:SHMN) اعترف بالتعليقات الأخيرة من FDA وتحليلات الصناعة التي أشارت إلى إطار تشريعي متطور لتقنيات تعديلات الجينوم في تاريخ 4 نوفمبر 2025. قالت الشركة أن الجهات التنظيمية تتركز بشكل متزايد على أدوات دقيقة مصممة، وطرائق التوصيل غير الفيروسية، وتصنيع يمكن توسيعه.
تقوم SOHM بتطوير منصتها الملكية للهندسة الجينومية ABBIE في التطوير قبل السريري؛ وتوصف ABBIE بأنها بنية إنزيمات قابلة للبرمجة مصممة لتمكين أحداث إدراج DNA دون ناقلات فيروسية. وأكد الإدارة على استمرار العمل قبل السريري على السلامة والآلية وإمكانية التكرار.
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CHINO HILLS, CALIFORNIA / ACCESS Newswire / November 4, 2025 / SOHM, Inc. (OTCID:SHMN), a pharmaceutical and biotechnology company specializing in generic drugs and gene-editing tools, a leader in Gene Editing and Cell Engineering is pleased to acknowledge recent FDA commentary and industry analyses signaling continued evolution of regulatory pathways for genome-editing technologies. These developments highlight increasing regulatory focus on precision-engineered genetic tools, non-viral delivery approaches, and scalable manufacturing frameworks.
SOHM is advancing its proprietary ABBIE™ genome-engineering platform, which is designed to enable DNA-insertion events through a programmable enzyme architecture. ABBIE is currently in preclinical development.
"As regulatory frameworks evolve, emphasis continues to be placed on genomic safety, process control, and manufacturing rigor," said David Aguilar, COO of SOHM.
"ABBIE was designed to support controlled genomic engineering without the use of viral vectors, and our preclinical work continues to focus on establishing safety, mechanism, and reproducibility."
For more information about SOHM Inc. and its groundbreaking work in biotechnology, please visit www.SOHM.com.
About SOHM, Inc.:
SOHM is a biopharmaceutical company dedicated to developing and commercializing gene editing technologies for research, synthetic biology, and therapeutic applications. With a focus on precision medicine, SOHM aims to revolutionize the treatment of genetic diseases by providing safe, efficient, and targeted gene editing solutions. Through strategic collaborations and groundbreaking research, SOHM is at the forefront of advancing the field of gene therapy. SOHM strives to transform the landscape of genome editing and improve the quality of life through scientific discovery.
For further information regarding this announcement or to explore potential collaborations, please contact:
SOHM, Inc.:
Name: Baron Night, CEO/Dr. David Aguilar, COO
Email: info@sohm.com
Phone: (714) 522-6700
Safe Harbor Statement:
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SOURCE: SOHM, Inc
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FAQ
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