RESTORING
IMMUNE BALANCE
™
TREGCEL™, A REGULATORY T CELL THERAPY PLATFORM
A novel therapeutic approach for organ transplant and autoimmune diseases.
PERSONALIZED TECHNOLOGY
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.
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In 2021, over 41,000 Americans underwent organ transplant surgery.
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At least 50% of transplanted organs start a rejection process within 10 years.
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Transplant patients require life-long use of immunosuppressive drugs to prevent transplant rejections.
Autoimmune Disease
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.
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There are approximately 24 million Americans suffering from at least one autoimmune disease.
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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.
Patent issued for novel method and composition; second US patent for novel method and composition
pending. EPO and PCT patents are in National Phase.