RESTORING
IMMUNE BALANCE

TREGCEL™, A REGULATORY T CELL THERAPY PLATFORM

A novel therapeutic approach for organ transplant and autoimmune diseases.

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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

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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 41,000 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.

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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.
 

  • 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.

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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.