Sernova Biotherapeutics Provides Update on Phase 1/2 Clinical Trial of Cell Pouch™ Bio-Hybrid Organ for Treatment of Type 1 Diabetes
Sernova Biotherapeutics (SEOVF) has received DSMB approval to advance its Phase 1/2 clinical trial for type 1 diabetes treatment using the Cell Pouch™ Bio-hybrid Organ system. The trial's Data and Safety Management Board has authorized enrollment of the final patient in Cohort B, with plans to progress to Cohort C in H2 2025.
The primary endpoint focuses on demonstrating safety and tolerability of islet transplantation into Cell Pouch for T1D patients with hypoglycemia unawareness. The company reports being on track to achieve this endpoint based on current clinical data.
The Cell Pouch™ system, described as the only implantable and retrievable cell containment system for islet engraftment in U.S. clinical trials, has shown islet cell survival in patients ranging from one to five years, with demonstrated ability to support insulin independence. Following trial completion, Sernova plans to initiate a new clinical trial using iPSC islet-like clusters in collaboration with Evotec.
Sernova Biotherapeutics (SEOVF) ha ricevuto l'approvazione del DSMB per avanzare nel suo studio clinico di fase 1/2 per il trattamento del diabete di tipo 1 utilizzando il sistema Bio-ibrido Cell Pouch™. Il Comitato per la gestione dei dati e della sicurezza ha autorizzato l'arruolamento dell'ultimo paziente nel Coorte B, con piani per progredire al Coorte C nel secondo semestre del 2025.
L'obiettivo principale si concentra sulla dimostrazione della sicurezza e della tollerabilità del trapianto di isole nel Cell Pouch per i pazienti T1D con incapacità di riconoscere l'ipoglicemia. L'azienda riferisce di essere sulla buona strada per raggiungere questo obiettivo sulla base dei dati clinici attuali.
Il sistema Cell Pouch™, descritto come l'unico sistema di contenimento cellulare impiantabile e recuperabile per l'innesto di isole negli studi clinici negli Stati Uniti, ha mostrato la sopravvivenza delle cellule isletiche nei pazienti che va da uno a cinque anni, con la capacità dimostrata di supportare l'indipendenza dall'insulina. Al termine dello studio, Sernova prevede di avviare un nuovo studio clinico utilizzando cluster simili a isole derivati da iPSC in collaborazione con Evotec.
Sernova Biotherapeutics (SEOVF) ha recibido la aprobación del DSMB para avanzar en su ensayo clínico de fase 1/2 para el tratamiento de la diabetes tipo 1 utilizando el sistema Bio-híbrido Cell Pouch™. La Junta de Gestión de Datos y Seguridad ha autorizado la inscripción del último paciente en el Cohorte B, con planes de avanzar al Cohorte C en el segundo semestre de 2025.
El objetivo principal se centra en demostrar la seguridad y tolerabilidad del trasplante de islotes en el Cell Pouch para pacientes T1D con falta de conciencia de hipoglucemia. La empresa informa que está en camino de alcanzar este objetivo según los datos clínicos actuales.
El sistema Cell Pouch™, descrito como el único sistema de contención celular implantable y recuperable para el injerto de islotes en ensayos clínicos en EE. UU., ha mostrado supervivencia de células islotes en pacientes durante uno a cinco años, con la capacidad demostrada de soportar la independencia de insulina. Tras la finalización del ensayo, Sernova planea iniciar un nuevo ensayo clínico utilizando grupos similares a islotes derivados de iPSC en colaboración con Evotec.
Sernova Biotherapeutics (SEOVF)는 Cell Pouch™ 바이오 하이브리드 장치 시스템을 사용하여 제1형 당뇨병 치료를 위한 1/2상 임상 시험을 진행할 DSMB 승인을 받았습니다. 데이터 및 안전 관리 위원회는 Cohort B의 마지막 환자 등록을 승인했으며, 2025년 하반기에는 Cohort C로 진행할 계획입니다.
주요 목표는 저혈당 인식 부족이 있는 T1D 환자를 위한 Cell Pouch에 대한 췌장섬 이식의 안전성과 내약성을 입증하는 데 중점을 두고 있습니다. 회사는 현재의 임상 데이터를 기반으로 이 목표를 달성할 수 있는 궤도에 있다고 보고하고 있습니다.
Cell Pouch™ 시스템은 미국 임상 시험에서 췌장섬 이식을 위한 유일한 이식 가능하고 회수 가능한 세포 격리 시스템으로 설명되며, 환자에서 1년에서 5년까지 췌장섬 세포 생존률을 보여주었으며, 인슐린 독립성을 지원하는 능력이 입증되었습니다. 시험이 완료된 후, Sernova는 Evotec과 협력하여 iPSC 유사 췌장섬 클러스터를 사용하는 새로운 임상 시험을 시작할 계획입니다.
Sernova Biotherapeutics (SEOVF) a reçu l'approbation du DSMB pour faire progresser son essai clinique de phase 1/2 pour le traitement du diabète de type 1 utilisant le système d'organe bio-hybride Cell Pouch™. Le Conseil de gestion des données et de la sécurité a autorisé l'inscription du dernier patient dans la Cohorte B, avec des projets de passer à la Cohorte C au second semestre 2025.
L'objectif principal vise à démontrer la sécurité et la tolérabilité de la transplantation d'îlots dans le Cell Pouch pour les patients T1D ayant une insensibilité à l'hypoglycémie. L'entreprise rapporte être sur la bonne voie pour atteindre cet objectif sur la base des données cliniques actuelles.
Le système Cell Pouch™, décrit comme le seul système de confinement cellulaire implantable et récupérable pour l'implantation d'îlots dans les essais cliniques aux États-Unis, a montré la survie des cellules îlotées chez des patients allant d'un à cinq ans, avec une capacité démontrée à soutenir l'indépendance à l'insuline. À l'issue de l'essai, Sernova prévoit de lancer un nouvel essai clinique utilisant des clusters similaires à des îlots dérivés de iPSC en collaboration avec Evotec.
Sernova Biotherapeutics (SEOVF) hat die Genehmigung des DSMB erhalten, um seine klinische Studie der Phase 1/2 zur Behandlung von Typ-1-Diabetes mit dem Bio-hybrid-Organ-System Cell Pouch™ voranzutreiben. Der Data and Safety Management Board hat die Einschreibung des letzten Patienten in Kohorte B genehmigt, mit Plänen, im 2. Halbjahr 2025 zur Kohorte C überzugehen.
Das Hauptziel konzentriert sich darauf, die Sicherheit und Verträglichkeit der Inseltransplantation in das Cell Pouch für T1D-Patienten mit Hypoglykämie-Unkenntnis zu demonstrieren. Das Unternehmen berichtet, dass es auf dem richtigen Weg ist, dieses Ziel basierend auf den aktuellen klinischen Daten zu erreichen.
Das Cell Pouch™-System, das als das einzige implantierbare und wiederherstellbare Zellcontainmentsystem für die Inselverpflanzung in klinischen Studien in den USA beschrieben wird, hat die Überlebensrate von Inselzellen bei Patienten von ein bis fünf Jahren gezeigt, mit nachgewiesener Fähigkeit, die Insulinunabhängigkeit zu unterstützen. Nach Abschluss der Studie plant Sernova, eine neue klinische Studie mit iPSC-inselähnlichen Clustern in Zusammenarbeit mit Evotec zu starten.
- DSMB approval confirms safety profile and allows trial advancement
- Demonstrated islet cell survival for up to 5+ years
- Successfully achieving insulin independence in treated patients
- No evidence of detrimental fibrosis in Cell Pouch
- Only implantable and retrievable cell containment system in US clinical trials
- Trial still in early Phase 1/2 stage
- Final results not yet available
- Commercial launch timeline not specified
DSMB supports advancement for Sernova’s clinical trial
Study is on track to meet key clinical trial endpoints
LONDON, Ontario and BOSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing it’s Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today provided an update on its ongoing clinical trial in patients with T1D.
Yesterday, on March 31, the Data and Safety Management Board (DSMB) for Sernova’s Phase 1/2 clinical trial, conducted a scheduled annual data review. The DSMB has sanctioned the enrollment of the final patient in Cohort B. In addition, following consultation with the DSMB, Sernova is preparing to advance to Cohort C of the trial in H2 2025.
The primary endpoint of our ongoing Phase 1/2 clinical trial is the demonstration of safety and tolerability of islet transplantation into Cell Pouch for the treatment of T1D in patients with hypoglycemia unawareness and a history of severe hypoglycemic episodes. Based on the clinical data that Sernova has acquired to date, and the endorsement of safety from the DSMB, we believe we are on track to achieve this endpoint.
Upon conclusion of Cohort C, Sernova plans to launch a T1D clinical trial of the Cell Pouch™ Bio-hybrid Organ with induced pluripotent stem cell (iPSC) islet-like clusters in collaboration with Evotec.
We believe that Sernova’s Cell Pouch™ Bio-hybrid Organ, that is pre-vascularized prior to islet transplantation, is the only implantable and retrievable cell containment system for islet engraftment and function currently in U.S. clinical trials. Data from the ongoing trial has demonstrated islet cell survival in T1D patients from one year to more than five years as well as the ability to support insulin independence following protocol specified treatment. In addition, there has been no evidence of detrimental fibrosis of the Cell Pouch on histological analysis.
“We have collected a significant amount of data in our ongoing clinical trial and results to date suggest that we are tracking towards meeting our key clinical endpoints,” said Jonathan Rigby, President and CEO of Sernova Biotherapeutics. “We have made a great deal of strategic, operational and financing progress over recent months and as a type 1 diabetic myself, I am truly excited about the potential of our T1D Cell Pouch™ Bio-hybrid Organ and look forward to advancing our clinical trial to a positive conclusion.”
ABOUT SERNOVA BIOTHERAPEUTICS
Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics combining its Cell Pouch with human donor cells or stem-cell derived islet like clusters in collaboration with Evotec to create a Bio-hybrid Organ to treat T1D. A Bio-hybrid Organ is comprised of non-biomaterials, such as the Cell Pouch, integrated with living tissues to replace the function of a compromised organ. This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on T1D and thyroid disorders.
FOR FURTHER INFORMATION, PLEASE CONTACT:
David Burke VP, Investor Relations (917) 751-5713 Email: David.Burke@sernova.com Website: https://sernova.com/
The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release.
FORWARD-LOOKING INFORMATION
This press release contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this press release include our expectations that Sernova is on track to meet its primary endpoint, will launch a clinical trial with Evotec iPSC derived islet-like clusters in 2026, that Sernova will advance to Cohort C in the current trial, our belief that a functional cure requires a pre-vascularized containment device and our belief that Sernova is the only company to demonstrate islet cell survival for more than 5 years in a clinical trial with a pre-vascularized cell containment system. With respect to the forward-looking statements contained in this press release, Sernova has made numerous assumptions regarding, among other things: the company’s ability to secure additional financing on reasonable terms, or at all; and the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch, including the timing and results of those trials. A more complete discussion of the risks and uncertainties facing Sernova appears in Sernova’s Annual Information Form for the year ended October 31, 2024, filed with Canadian securities authorities and available at www.sedarplus.ca, as updated by Sernova’s continuous disclosure filings, which are available at www.sedarplus.ca. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Sernova disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
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