SEATTLE, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Pluristyx announced today the launch of a project up to $1.4 million, supported and funded by Breakthrough T1D, formerly JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization. The project will create and distribute a genetically engineered induced pluripotent stem cell (iPSC) line, providing developers with an important new tool that serves as the starting material for manufacturing the next generation of islet replacement therapies.

The project directly addresses one of the most significant barriers to a widespread T1D cure–the lack of a cell source that is both technically appropriate and commercially feasible for developers to license and use in the research, development, and manufacturing of life-saving treatments and cures. Manufactured Islet cell replacement therapy holds immense promise, with multiple documented clinical trial successes treating T1D. However, patient eligibility for approved donor-derived and investigational manufactured islet cell replacement therapies is limited to a small population because of chronic co-administration of immunosuppressive drugs needed to prevent rejection. The risk-benefit considerations for these immunosuppressive regimens exclude most people living with T1D, especially children, from accessing potentially curative islet cell replacement therapy.

Pluristyx’s platform technology was developed specifically to overcome this challenge. This Breakthrough T1D collaboration will fund the use of precise gene editing to engineer Pluristyx’s exclusively licensed immune-cloaking and safety-switch technologies into a US Food and Drug Administration (FDA) Drug Master File registered Pluristyx cell line:

• iACT™ (Induced Allogeneic Cell Tolerance): A patented “cloaking” technology allowing cells to evade immune system recognition without disrupting or “knocking-out” human leukocyte antigen (HLA) expression. iACT™ enabled cells are designed to be allogeneic, or “universal”, meaning they do not have to be HLA “matched” to the patient.
• FailSafe^®: A patented drug-inducible “safety switch” mechanism that allows selective elimination of unwanted proliferating cells (if they occur) post-transplantation by administration of a safe, inexpensive, globally approved drug available in both oral and IV formats.
• PSXi (Pluristyx Pluripotent Stem Cells): Registered under an FDA Drug Master File, PSXi013 is a proprietary polyclonal iPSC line specifically designed to support and enable complex genetic engineering while maintaining both genetic stability and differentiation capacity during large-scale pharmaceutical manufacturing.
  

The iPSC line produced from this project will serve as a renewable starting material for research, development, and manufacturing of “off-the-shelf” allogeneic therapies that do not require chronic immune suppression. This approach has the potential to enable safer, more accessible, and truly curative treatment for people living with T1D.

“Breakthrough T1D is committed to accelerating life-changing breakthroughs to cure, prevent, and treat type 1 diabetes and its complications,” said Sanjoy Dutta, Ph.D., Breakthrough T1D Chief Scientific Officer. “The development of cell therapies that work for everyone with T1D without the need for chronic immunosuppression is a priority for Breakthrough T1D. We look forward to the potential of Pluristyx’s innovative platform and approach to move us one step closer to making cell therapies a reality for the entire type 1 diabetes community.”

“We are honored by Breakthrough T1D’s funding support for our platform following their rigorous technical and feasibility review,” said Dr. Benjamin Fryer, CEO of Pluristyx. “Our goal is to make and provide a safe, universal cell line to groups developing next-generation islet therapies. Doing so may help make curative treatments accessible to all people living with type 1 diabetes, including children, without the need for immunosuppressive drugs.”

About Pluristyx

Pluristyx is the leading provider of advanced iPSC-based solutions for the cell and gene therapy industry, delivering a comprehensive platform designed to accelerate therapeutic development with unmatched speed, safety, and scalability. Leveraging proprietary mRNA bulk reprogramming and a polyclonal iPSC approach, Pluristyx produces genetically younger, more stable, and highly expandable cells. The company’s portfolio spans off-the-shelf, clinical-grade iPSC lines, custom gene editing and engineering, and innovative safety and immune-evasion technologies, including the FailSafe^® safety switch, iACT™ immune cloaking system, and HLA-null capabilities. Beyond cell sourcing, Pluristyx supports the entire development continuum, from concept to organoid-based disease modeling, high-throughput drug screening, and GMP-scale manufacturing, empowering therapeutic developers to streamline workflows, reduce risk, and accelerate the path to clinic.

About Breakthrough T1D, Formerly JDRF

As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition.

About Type 1 Diabetes (T1D)
T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts 9.5 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.

Media Contact:

Dr. Priya Baraniak
Chief Commercial & Development Officer, Pluristyx
priya@pluristyx.com