TREGCEL™, A REGULATORY T CELL THERAPY PLATFORM
A novel therapeutic approach for organ transplant and autoimmune diseases.
TRACT Therapeutics, Inc. is developing a personalized product, TregCel™, which can be used to treat solid organ transplant patients and patients suffering from an autoimmune disorder.
The product consists of a patient’s own regulatory T cells, which are expanded in a laboratory and given back to the patient as a single dose by infusion with the goal of establishing immune tolerance.
SIGNIFICANT CLINICAL NEED
Solid Organ Transplant
TregCel™ has the potential to prevent transplant rejection while reducing the need for potentially harmful, life-long immunosuppressive drug therapy.
In 2021, over 40,000 Americans underwent organ transplant surgery.
At least 50% of transplanted organs start a rejection process within 10 years.
Transplant patients require life-long use of immunosuppressive drugs to prevent transplant rejections.
TregCel™ has the potential to transfer a patient into a state of remission and reduce or eliminate the need for potentially harmful, life-long immunosuppression drug therapy.
There are approximately 24 million Americans suffering from at least one autoimmune disease.
Patients who suffer from an autoimmune disease require life-long use of potentially toxic immunosuppressive drugs to suppress their disease.
The risks associated with immunosuppressive drugs are well-known and can include life-threatening infections, cancer, arthritis, diabetes, hypertension, kidney damage, and other negative side effects.
Over time, immunosuppression drugs may lose their effectiveness.
EARLY CLINICAL SUCCESS
TregCel™ granted Orphan Drug Designation for the prevention of graft rejection following solid organ transplantation.
A Phase 1 clinical trial in kidney transplant demonstrated no safety concerns, and two-year patient biopsies were normal with no rejection.
PROPRIETARY MANUFACTURING METHODS
Streamlined, scalable manufacturing process established.
U.S. and European patent applications filed for novel method and composition discoveries. One US patent granted, one US and two European applications pending, and one US provisional application filed.