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Rückmeldung zur FDA-Sitzung bringt Turn Biotechnologies auf Kurs, als erstes Unternehmen für Langlebigkeit eine Zellverjüngungstherapie in die klinische Anwendung zu bringen
  • USA - English
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Turn Biotechnologies

News provided by

Turn Biotechnologies, Inc.

Oct 25, 2023, 08:30 ET

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  • FDA INTERACT-Sitzung prüft die Technologien, den Ansatz und die Pläne von ERA™ und eTurna™ und ebnet den Weg zur IND 
  • Unternehmen treibt den Fortschritt in der Zellregenerationstherapie weiter voran 

MOUNTAIN VIEW, Kalifornien, 25. Oktober 2023 /PRNewswire/ -- Turn Biotechnologies, ein Unternehmen für Zellverjüngung, das neuartige mRNA-Arzneimittel für nicht behandelbare, altersbedingte Erkrankungen entwickelt, erhielt während einer INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER Products, INTERACT) FDA-Sitzung eine positive Rückmeldung zur Überprüfung der Fortschritte und Pläne für seine therapeutische Behandlung zur Verjüngung von Hautzellen.

Im Mittelpunkt der Sitzung stand die weitere Entwicklung von TRN-001, der ersten Behandlung, die geschädigte Haut auf zellulärer Ebene repariert, ihre Integrität verbessert und Entzündungen und Zellalterung reduziert. Die Ergebnisse der INTERACT-Sitzung bedeuten, dass Turn Bio gut positioniert ist, um das erste Unternehmen zu sein, das eine Zellverjüngungstherapie in die klinische Erprobung bringt.

„Wir waren erfreut über die starke Übereinstimmung zwischen Turn Bios Ansatz zur Entwicklung von TRN-001 und den Kommentaren der FDA-Gutachter", sagte Anja Krammer, CEO von Turn Bio. „Wir freuen uns darauf, unsere vorklinischen Arbeiten voranzutreiben, während wir auf die Einreichung der IND hinarbeiten."

TRN-001 wurde mit der firmeneigenen ERA™-Technologie von Turn Bio entwickelt, einer mRNA-basierten Plattform zur Wiederherstellung der jugendlichen Funktion von Zellen.  Die Therapie wird mit dem eTurna™-Lipidpartikel-Trägersystem des Unternehmens verabreicht, das entwickelt wurde, um Medikamente effektiv und gezielt an bestimmte Gewebe im Körper zu bringen.

INFORMATIONEN ZU TURN BIOTECHNOLOGIES 

Turn Bio ist ein Unternehmen in der vorklinischen Phase, das sich auf die Reparatur von Gewebe auf zellulärer Ebene und die Entwicklung neuartiger Arzneimittelabgabesysteme konzentriert. Die firmeneigene mRNA-basierte ERA™-Technologie bekämpft die Auswirkungen des Alterns im Epigenom und stellt so die optimale Genexpression wieder her. Dadurch wird die Fähigkeit der Zellen, Krankheiten vorzubeugen oder zu behandeln und Gewebe zu heilen oder zu regenerieren, wiederhergestellt. Dies wird dazu beitragen, unheilbare chronische Krankheiten zu bekämpfen. Die eTurna™-Delivery-Plattform verwendet einzigartige Rezepturen, um Stoffe präzise zu bestimmten Organen, Geweben und Zelltypen zu bringen.

Das Unternehmen schließt derzeit die vorklinische Forschung an maßgeschneiderten Therapien für Indikationen in der Dermatologie und Immunologie ab und entwickelt Therapien für die Augenheilkunde, Osteoarthritis und das Muskelsystem. Weitere Informationen finden Sie unter www.turn.bio

FÜR WEITERE INFORMATIONEN WENDEN SIE SICH BITTE AN:

Jim Martinez, rightstorygroup
[email protected] oder (312) 543-9026

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