LyGenesis Awarded to Advance Immune Tolerance for Type 1 Diabetes Treatment

PITTSBURGH, PA – June 25, 2026 – Clinical-stage biotechnology company LyGenesis, Inc. today announced it has received a research award from Breakthrough T1D, the leading global organization for type 1 diabetes (T1D) research and advocacy. The award will fund a pivotal preclinical research project aimed at overcoming one of the most significant hurdles in T1D treatment: immune rejection following pancreatic islet transplantation.

The research will be led by Dr. Eric Lagasse, Professor of Pathology at the University of Pittsburgh and Chief Scientific Officer at LyGenesis. The project builds upon his pioneering work in regenerative medicine and seeks to induce immune tolerance, potentially eliminating the need for lifelong immunosuppressive drugs for transplant recipients.

The Promise and Peril of Islet Transplantation

For millions living with Type 1 Diabetes, an autoimmune disease where the body destroys its own insulin-producing cells, life is a constant balance of blood sugar monitoring and insulin injections. While life-saving, this regimen does not cure the disease. Pancreatic islet transplantation offers a more profound hope: by infusing insulin-producing cells from a donor pancreas into a patient, it's possible to restore the body's natural ability to regulate blood sugar.

However, this promising therapy has been limited by a critical challenge. The recipient's immune system recognizes the new islet cells as foreign invaders and mounts an attack to destroy them. To prevent this rejection, patients must take powerful immunosuppressive drugs for the rest of their lives. These medications come with a host of severe side effects, including a heightened risk of infection, kidney damage, and even certain cancers. This trade-off means that islet transplantation is currently reserved for only the most severe cases of T1D.

Even with immunosuppression, long-term success is not guaranteed. Many patients who initially achieve insulin independence find their transplanted grafts failing within a few years, forcing them to return to insulin therapy. The core challenge remains: how to protect the transplanted cells without compromising the patient's entire immune system.

A Novel Approach: The Lymph Node as a Bioreactor

LyGenesis is tackling this problem with a revolutionary platform technology that turns a patient's own lymph nodes into living bioreactors. This approach is based on a foundational discovery by Dr. Lagasse, who found that cells transplanted into lymph nodes could not only survive but organize and grow into functional, miniature ectopic organs.

This new project, supported by Breakthrough T1D, will apply this technology to the thymus—a small but vital gland responsible for training the immune system's T cells to recognize the difference between 'self' and 'other.' The plan is to use LyGenesis's platform to grow a small, functional piece of thymus tissue within a patient's lymph node. This ectopic thymus would then 're-educate' the immune system, teaching it to tolerate the newly transplanted pancreatic islets. If successful, this could create a state of localized immune tolerance specific to the transplant, sidestepping the need for systemic immunosuppression.

"We are grateful for the support of our translational research pipeline, which continues to expand beyond liver regeneration," said Dr. Lagasse. The award from Breakthrough T1D serves as a powerful endorsement of this innovative strategy, aligning with the organization's mission to fund high-risk, high-reward research with the potential to cure, prevent, and treat T1D.

The 'Thymus Renaissance' and a Platform for Regeneration

The scientific community's growing excitement around this area of research was recently highlighted in a Nature Biotechnology feature titled "Thymus Renaissance Poised to Boost Health and Longevity," which recognized LyGenesis as a key player. This 'thymus renaissance' reflects a deeper understanding of the organ's role not just in early life immunity but in ongoing immune health, cancer response, and even aging.

For LyGenesis, the Breakthrough T1D award is a strategic expansion of its versatile cell therapy platform. The company's lead program is already in a Phase 2a clinical trial (NCT04496479) for patients with end-stage liver disease (ESLD). In that trial, liver cells from a single donor organ are used to treat multiple patients, with the cells being transplanted into the lymph nodes to grow into functional ectopic livers. The trial recently received a positive review from its Data and Safety Monitoring Board, which recommended the study continue and escalate to a higher dose, signaling strong early safety and tolerability.

Beyond the liver and thymus, LyGenesis is also developing therapies for the pancreas and kidneys, all based on its core lymph node bioreactor platform. This approach has the potential to fundamentally change the economics of organ transplantation. By using cells from a single donor organ to treat dozens of patients via a minimally invasive outpatient procedure, the company aims to address the chronic shortage of donor organs and make regenerative therapies more accessible. This latest funding from Breakthrough T1D marks another crucial step toward realizing that vision, bringing new hope to patients awaiting a true cure for Type 1 Diabetes.