SCIENCE + TECHNOLOGY
The technology is a cell-based biologic therapy platform using Treg Adoptive Cell Transfer (TRACT).
The platform involves the isolation and expansion of a patient’s own naturally occurring regulatory T cells, known as Tregs. Tregs represent a critical pathway through which the immune system can actively down-regulate immune responses and significantly contribute to immune tolerance.
MECHANISM OF ACTION
Interacting and suppressing activity of “effector cells”
Converting naïve, uncommitted
T cells into Tregs, a process known as infectious tolerance
Influencing other cells in the immune system to reduce inflammation and promote tolerance
Issa F, Chandrasekharan D, Wood KJ. Regulatory T cells as modulators of chronic allograft dysfunction Curr Opin Immunol. 2011 Oct;23(5):648-54.
THE TREATMENT PROCESS
Collect cells by leukapheresis
Ship cells to manufacturer
Manufacturer cryopreserves (freezes) cells
Cell selection and expansion begins 21-23 days before treatment
Fresh final product is shipped cold to infusion center
Final product is administered by IV to patient
After a patient receives an organ transplant, the immune system will identify the transplanted organ as a threat or as “foreign” and will launch an attack with T cells and antibodies made by B cells. As time passes, the T cells and antibodies will cause harm to the transplanted organ which will lead to damage, failure, or rejection.
Currently, transplant patients are required to take powerful anti-rejection
medications (also known as immunosuppressive drugs) for life.
One goal within the transplant community is to reduce or eliminate
immunosuppressive drug therapy and promote transplantation tolerance using alternative therapies.
The use of TRACT technology (TregCel™) could reduce the immunosuppressive medications needed, prevent rejection and loss of the transplanted organ, and free up the number of organ donations available to waiting patients.
Approach to Eliminating Rejection with TregCel™
Our innovative approach was developed from over 20 years of research focused on creating transplant tolerance using isolated and expanded naturally occurring regulatory T cells (Tregs) to modulate immune responses and significantly contribute to immune tolerance.
A completed Phase 1 clinical trial in living donor kidney transplant patients showed:
Infusion with polyclonally expanded Tregs up to 5 billion cells is safe.
No infusion-related serious adverse events.
Two-year biopsies were normal with no rejection.
TregCel™ was associated with an increase in circulating numbers of Tregs in the immune system: this biomarker has been linked to development of tolerance in kidney and liver transplant recipients.
A Phase 2 clinical trial in living donor kidney transplant patients is planned. We hope to demonstrate in this Phase 2 trial, and in future clinical trials, that treatment with TregCel™ results in a durable response in preventing loss of a transplanted organ while allowing for a reduction or possible withdrawal of all immunosuppressive drug therapy.
The wait for an organ usually takes several years. Currently, there are over 103,000 people on the U.S. organ transplant waiting list.
According to the U.S. Dept. of Health & Human Services, at least 17 people die each day waiting for transplants that cannot take place because of the shortage of donated organs.
In 2023, over 46,000 Americans underwent organ transplant surgery.
Transplant patients require life-long use of immunosuppressive drugs to prevent transplant rejections.
Immunosuppressive therapy is expensive and may cost a patient anywhere from $10,000 to $14,000 per year.
At least 50% of transplanted organs start a rejection process within 10 years with current standard-of-care immunosuppressive drugs requiring a second (or third) organ transplant.
Inherited defects in Tregs has been associated with a clinical phenotype of autoimmune disorders, including inflammatory bowel disease. CD4 T cell subsets of Tregs are known to be deficient in Crohn’s Disease and depletion of Treg cells and imbalance of Treg to T effector cells plays a key role in the pathogenesis of Crohn’s Disease.
The use of TRACT technology (TregCel™) for autoimmune disease has the potential to transfer the disease to a remission state while reducing or eliminating the use of harmful immunosuppressive drug therapy.
TRACT Therapeutics is pursuing autoimmune indications that are highly dependent on immunosuppressive drug therapy.
A Phase 1B Safety and Efficacy clinical trial in Crohn’s Disease is planned as the initial investigation into this important indication.
Reports also indicate that there are 50 million Americans suffering from an autoimmune disease.
There are currently 3.1 million Americans living with an inflammatory bowel disease.
As a result of their disease, most patients face challenges that have an emotional and physical impact on their lives that interfere with everyday activities such as going to work or participating in events.
Patients who suffer from an autoimmune disease require life-long use of
potentially toxic immunosuppressive drugs to suppress their disease.