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TRACT Therapeutics, Inc. Completes Phase I Safety Trial

Updated: May 21, 2022

TRACT Therapeutics, Inc. Completes Phase I Safety Trial Using a Patient’s Immune Cells to Prevent Organ Rejection

Safety Data Presented at the American Transplant Congress Meeting Demonstrated Excellent Patient Tolerability and Supports the Start of a Phase II Trial Additional Data Analysis Showed Positive Signals Toward Efficacy

CHICAGO–(BUSINESS WIRE)– TRACT Therapeutics, Inc. announced today that it has completed a first-in-human Phase I Trial to study the safety of the use of a patient’s own immune system cells in kidney transplant recipients. The study, approved by the Food and Drug Administration (FDA), was conducted at Northwestern Memorial Hospital. The therapeutic approach utilizing a patient’s own cells expanded in the laboratory and reinfusing them after the organ transplant shows great promise in restoring immune balance so the body will accept the foreign organ instead of rejecting it. Current standard of care practices for transplant patients includes the required lifetime use of toxic medications which weaken the immune system causing life-threatening effects and eventual rejection of the organ. TRACT’s approach aims to reduce or eliminate the lifelong use of immunosuppressive drug therapy.

Approximately 30,000 patients receive a solid organ transplant in the United States each year; 18,000 of which are kidneys. Joseph R. Leventhal, MD, PhD, Director of Kidney and Pancreas Transplantation at Northwestern University Feinberg School of Medicine stated:

“The opportunity to provide an alternative therapy that will actually regulate the patient’s immune system instead of suppressing it with drugs, presents a tremendous opportunity to resolve a clinical need that has not been met with for patients with organ transplants and autoimmune diseases.”

Gretchen S. Johnson, President and CEO of TRACT Therapeutics, commented, “Today’s announcement signifies a major milestone for both the early success of this clinical approach and the potential to improve the lives of patients with transplants and those suffering from autoimmune disorders.”


About TRACT Therapeutics

TRACT Therapeutics, Inc. is a clinical stage biotechnology company developing a novel therapeutic approach to restoring immune balance in organ transplantation and autoimmune disease. Its proprietary platform technology, using autologous polyclonally expanded regulatory Tcells was developed at Northwestern University by pioneer, Joseph R Leventhal, MD, PhD and his research colleagues. TRACT has recently received FDA approval to initiate a Phase 2 trial with Trigs in kidney recipients.

This press release contains forwardlooking statements that express the belief, potential anticipation or expectation, as well as other statements which are not historical fact, and statements related to clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality and performance. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward looking statements.

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