Sernova Biotherapeutics Announces Collaboration with Eledon Pharmaceuticals to Advance a Potential Functional Cure for Type 1 Diabetes
Sernova Biotherapeutics (OTCQB:SEOVF) has announced a significant collaboration with Eledon Pharmaceuticals to advance their Type 1 Diabetes (T1D) treatment program. The partnership will evaluate Eledon's immunosuppressive agent tegoprubart in Cohort C of Sernova's Phase 1/2 clinical trial of its Cell Pouch Bio-hybrid Organ.
The collaboration aims to replace tacrolimus with tegoprubart, as previous studies showed promising results where T1D patients achieved normal blood sugar levels and insulin independence. Notably, islet engraftment was 3-5 times higher with tegoprubart compared to tacrolimus-based immunosuppression, with better graft survival and function.
The partnership combines Sernova's retrievable Bio-hybrid Organ technology with Evotec's stem cell-derived islet-like clusters and Eledon's innovative immunosuppression approach, positioning it as a potential leading solution for a functional T1D cure.
Sernova Biotherapeutics (OTCQB:SEOVF) ha annunciato una collaborazione importante con Eledon Pharmaceuticals per far avanzare il loro programma di trattamento del Diabete di Tipo 1 (T1D). La partnership valuterà l'agente immunosoppressore di Eledon, tegoprubart, nella Coorte C della sperimentazione clinica di Fase 1/2 di Sernova sul suo Organo Bio-ibrido Cell Pouch.
L'obiettivo della collaborazione è sostituire il tacrolimus con il tegoprubart, poiché studi precedenti hanno mostrato risultati promettenti in cui i pazienti con T1D hanno raggiunto livelli normali di zucchero nel sangue e indipendenza dall'insulina. In particolare, l'attecchimento delle isole pancreatiche è stato 3-5 volte superiore con tegoprubart rispetto all'immunosoppressione a base di tacrolimus, con una migliore sopravvivenza e funzionalità del trapianto.
La partnership unisce la tecnologia dell'Organo Bio-ibrido estraibile di Sernova con i cluster simili alle isole derivati da cellule staminali di Evotec e l'approccio innovativo di immunosoppressione di Eledon, posizionandola come una possibile soluzione leader per una cura funzionale del T1D.
Sernova Biotherapeutics (OTCQB:SEOVF) ha anunciado una colaboración significativa con Eledon Pharmaceuticals para avanzar en su programa de tratamiento para la Diabetes Tipo 1 (T1D). La asociación evaluará el agente inmunosupresor de Eledon, tegoprubart, en la Cohorte C del ensayo clínico de Fase 1/2 de Sernova para su Órgano Bio-híbrido Cell Pouch.
La colaboración tiene como objetivo reemplazar el tacrolimus con tegoprubart, ya que estudios previos mostraron resultados prometedores donde los pacientes con T1D lograron niveles normales de azúcar en sangre e independencia de la insulina. Notablemente, el injerto de islotes fue 3-5 veces mayor con tegoprubart en comparación con la inmunosupresión basada en tacrolimus, con mejor supervivencia y función del injerto.
La asociación combina la tecnología de órgano bio-híbrido extraíble de Sernova con los cúmulos similares a islotes derivados de células madre de Evotec y el innovador enfoque de inmunosupresión de Eledon, posicionándola como una posible solución líder para una cura funcional de la T1D.
Sernova Biotherapeutics (OTCQB:SEOVF)가 Eledon Pharmaceuticals와 제1형 당뇨병(T1D) 치료 프로그램을 진전시키기 위한 중요한 협력을 발표했습니다. 이번 파트너십은 Sernova의 세포 주머니 바이오 하이브리드 장기 1/2상 임상시험 코호트 C에서 Eledon의 면역억제제 tegoprubart를 평가할 예정입니다.
협력의 목적은 이전 연구에서 T1D 환자들이 정상 혈당 수치와 인슐린 독립성을 달성한 유망한 결과를 보여준 만큼 tacrolimus를 tegoprubart로 대체하는 것입니다. 특히, tegoprubart를 사용한 경우 이식편의 정착률이 tacrolimus 기반 면역억제보다 3-5배 더 높았으며, 이식편의 생존과 기능도 향상되었습니다.
이번 파트너십은 Sernova의 회수 가능한 바이오 하이브리드 장기 기술과 Evotec의 줄기세포 유래 이자 유사 클러스터, 그리고 Eledon의 혁신적인 면역억제 방식을 결합해 기능적 T1D 치료의 선도적 솔루션으로 자리매김할 전망입니다.
Sernova Biotherapeutics (OTCQB:SEOVF) a annoncé une collaboration importante avec Eledon Pharmaceuticals pour faire progresser leur programme de traitement du diabète de type 1 (T1D). Ce partenariat évaluera l'agent immunosuppresseur de Eledon, tegoprubart, dans la cohorte C de l'essai clinique de phase 1/2 de Sernova sur son Organe Bio-hybride Cell Pouch.
L'objectif de cette collaboration est de remplacer le tacrolimus par le tegoprubart, car des études antérieures ont montré des résultats prometteurs où les patients atteints de T1D ont atteint des niveaux normaux de glycémie et une indépendance à l'insuline. Notamment, l'implantation des îlots a été 3 à 5 fois supérieure avec le tegoprubart comparé à l'immunosuppression à base de tacrolimus, avec une meilleure survie et fonction de la greffe.
Ce partenariat combine la technologie d'organe bio-hybride récupérable de Sernova avec les amas d'îlots dérivés de cellules souches d'Evotec et l'approche innovante d'immunosuppression d'Eledon, ce qui en fait une solution potentielle de premier plan pour une cure fonctionnelle du T1D.
Sernova Biotherapeutics (OTCQB:SEOVF) hat eine bedeutende Zusammenarbeit mit Eledon Pharmaceuticals angekündigt, um ihr Behandlungsprogramm für Typ-1-Diabetes (T1D) voranzutreiben. Die Partnerschaft wird Eledons Immunsuppressivum tegoprubart in Kohorte C der Phase 1/2-Studie von Sernovas Cell Pouch Bio-hybrid Organ evaluieren.
Ziel der Zusammenarbeit ist es, Tacrolimus durch Tegoprubart zu ersetzen, da frühere Studien vielversprechende Ergebnisse zeigten, bei denen T1D-Patienten normale Blutzuckerwerte und Insulinunabhängigkeit erreichten. Bemerkenswert war, dass die Insel-Transplantationsrate mit Tegoprubart im Vergleich zur Tacrolimus-basierten Immunsuppression 3-5 Mal höher war, mit besserem Überleben und Funktion des Transplantats.
Die Partnerschaft vereint Sernovas rückholbare Bio-hybrid Organ-Technologie mit Evotecs stammzellabgeleiteten Insel-ähnlichen Clustern und Eledons innovativem Immununterdrückungsansatz und positioniert sich damit als potenzielle führende Lösung für eine funktionelle T1D-Heilung.
- Previous tegoprubart studies showed 3-5 times higher islet engraftment compared to tacrolimus
- Three patients achieved normal blood sugar levels and insulin independence in previous tegoprubart trials
- Tegoprubart demonstrated better protection of transplanted islets with improved graft survival
- Treatment showed good tolerability with no unexpected adverse events
- Current standard immunosuppressant (tacrolimus) shows toxicity toward insulin-producing beta cells
- The treatment is still in clinical trial phase with unproven long-term efficacy
Tegoprubart to be Used as Immunosuppressive Agent in Cohort C of Sernova’s Phase 1/2 Cell Pouch Bio-hybrid Organ Clinical Trial in Patients with Type 1 Diabetes
LONDON, Ontario, July 09, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics (“Sernova”) (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH) today announced a Collaborative Research Agreement with Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) to evaluate Eledon’s immunosuppressive agent tegoprubart (AT-1501) in Sernova’s ongoing Phase 1/2 clinical trial of its Cell Pouch Bio-hybrid Organ in patients with type 1 diabetes (T1D).
Under the terms of the agreement, Eledon will supply tegoprubart, an investigational anti-CD40L antibody being evaluated for its potential to prevent transplant rejection in islet cell, kidney and xeno transplantation, will be used in place of tacrolimus in the upcoming Cohort C of Sernova’s Phase 1/2 clinical trial. Tacrolimus is currently a standard immunosuppressive drug used in organ transplantation to prevent rejection. However, its potential toxicity, particularly toward insulin-producing beta cells, and its side effect profile limit its suitability as an optimal immunosuppressive agent for islet cell therapy in T1D.
In an investigator-initiated study led by Dr. Piotr Witkowski, a leading expert in islet transplantation at the University of Chicago, T1D patients received islet transplants along with tegoprubart to prevent rejection. Three participants achieved normal, stable blood sugar levels and became insulin independent. Islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than in comparable subjects outside this study who received tacrolimus-based immunosuppression, suggesting treatment with tegoprubart better protects transplanted islets resulting in improved graft survival and function. Treatment was generally well tolerated in all subjects with no unexpected adverse events or severe hypoglycemic episodes.
“As a person living with type 1 diabetes, I am very excited by the promising results demonstrated in recent clinical trials of tegoprubart. These data suggest that combining our Cell Pouch Bio-hybrid Organ technology with Eledon’s innovative immunosuppression could enable patients to achieve insulin independence more rapidly and with significantly less toxicity to islet cells,” stated Jonathan Rigby, Sernova’s CEO. “It’s great to see that other companies are generating positive T1D data using non-retrievable stem cell islets implanted in the liver. By transitioning to Evotec’s stem cell-derived islet-like clusters in our fully retrievable Bio-hybrid Organ and using tegoprubart as a key part of immunosuppression, we believe we will offer the leading product in the field and enhance our potential to deliver a functional cure for T1D.”
“We are pleased to partner with Sernova as they advance their Cell Pouch Bio-hybrid Organ in clinical trials,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Our anti-CD40L antibody, tegoprubart, has demonstrated strong potential to protect transplanted cells without the toxicities of standard immunosuppression, and we believe combining it with Sernova’s technology and cells could transform the treatment landscape for patients living with type 1 diabetes.”
This collaboration highlights the shared commitment of both companies to address the unmet needs of individuals living with T1D. By combining their expertise and leveraging complementary technologies, Sernova and Eledon aim to deliver a therapeutic solution that offers a durable and effective alternative to daily insulin injections and current immunosuppressive protocols.
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 bio-hybrid organs to treat T1D. A bio-hybrid organ is comprised of non-biomaterials, such as the Cell Pouch, integrated with living tissues to restore or enhance 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 expectation to use tegoprubart in Cohort C of our trial and the belief that the combination of Sernova and Eledon technologies could provide significant benefits to patients with T1D. 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 regulatory approval, 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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