Sernova Biotherapeutics Announces Collaboration with Eledon Pharmaceuticals to Advance a Potential Functional Cure for Type 1 Diabetes

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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