Sernova Biotherapeutics has announced a collaborative research agreement with Eledon Pharmaceuticals to evaluate tegoprubart, an investigational anti-CD40L antibody, in Sernova's ongoing Phase 1/2 clinical trial of its Cell Pouch Bio-hybrid Organ technology for type 1 diabetes patients. The partnership represents a significant advancement in the pursuit of a functional cure for type 1 diabetes by combining innovative cell therapy with next-generation immunosuppression.
Novel Immunosuppression Approach
Under the collaboration terms, Eledon will supply tegoprubart (AT-1501) to replace tacrolimus in the upcoming Cohort C of Sernova's Phase 1/2 clinical trial. Tacrolimus, while currently a standard immunosuppressive drug used in organ transplantation, presents significant limitations for islet cell therapy due to its potential toxicity toward insulin-producing beta cells and adverse side effect profile.
Tegoprubart, an investigational anti-CD40L antibody, is being evaluated for its potential to prevent transplant rejection in islet cell, kidney and xenotransplantation applications. The drug offers a promising alternative to conventional immunosuppression protocols that may better protect transplanted islets while reducing treatment-related toxicity.
Promising Clinical Evidence
Clinical validation for tegoprubart's potential comes from an investigator-initiated study led by Dr. Piotr Witkowski, a leading expert in islet transplantation at the University of Chicago. In this study, type 1 diabetes patients received islet transplants along with tegoprubart to prevent rejection, with remarkable results.
Three participants achieved normal, stable blood sugar levels and became insulin independent. Critically, islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than in comparable subjects who received tacrolimus-based immunosuppression. This suggests that tegoprubart treatment better protects transplanted islets, resulting in improved graft survival and function.
The treatment was generally well tolerated across all subjects, with no unexpected adverse events or severe hypoglycemic episodes reported during the study period.
Bio-hybrid Organ Technology
Sernova's Cell Pouch Bio-hybrid Organ represents an innovative approach to treating type 1 diabetes through regenerative medicine. The technology combines the Cell Pouch with human donor cells or stem cell-derived islet-like clusters developed in collaboration with Evotec to create functional bio-hybrid organs.
According to the company, a bio-hybrid organ comprises non-biomaterials, such as the Cell Pouch, integrated with living tissues to restore or enhance the function of a compromised organ. This approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on type 1 diabetes and thyroid disorders.
Leadership Perspectives
"As a person living with type 1 diabetes, I am very excited by the promising results demonstrated in recent clinical trials of tegoprubart," stated Jonathan Rigby, Sernova's CEO. "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."
Rigby emphasized the competitive advantage of their approach: "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."
David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon, expressed enthusiasm about the partnership: "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."
Therapeutic Implications
The collaboration addresses significant unmet needs in type 1 diabetes treatment by potentially offering a durable and effective alternative to daily insulin injections and current immunosuppressive protocols. By combining complementary technologies and expertise from both companies, the partnership aims to advance therapeutic solutions that could fundamentally change how type 1 diabetes is managed.
The retrievable nature of Sernova's Cell Pouch technology, combined with the enhanced islet protection offered by tegoprubart, represents a potentially transformative approach to achieving insulin independence in type 1 diabetes patients while minimizing the risks associated with conventional immunosuppression.
