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TRACT Therapeutics, Inc. Receives Orphan-Drug Designation for TRK-001 from the U.S. FDA

Updated: May 21, 2022

TRACT Therapeutics, Inc. Receives Orphan-Drug Designation for TRK-001 from the U.S. Food and Drug Administration for the Prevention of Graft Rejection Following Solid Organ Transplantation

TRACT Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s investigational candidate, TRK-001, for its potential to prevent graft rejection following solid organ transplantation.

TRK-001 is an autologous regulatory T-cell therapy that utilizes a patient’s own cells that are expanded ex vivo and infused back into the patient after a solid organ transplant. This therapeutic approach shows promise in restoring immune balance so the body will accept the foreign organ after transplantation. Current standard of care practices for transplant patients to prevent rejection requires the lifetime use of immunosuppressive medications.

These drugs have been shown to weaken the immune system, increase the risk of infection, and other potentially life-threatening conditions. Research has shown that, eventually, 50% of patients reject their transplanted organ. TRACT’s innovative approach aims to change the standard treatment for organ transplant recipients by reducing the lifelong use of immunosuppressive drug therapy.

“The limitations of drug based immunosuppression have significantly increased the interest in the use of regulatory T-cells to restore balance to the immune system and avoid transplant rejection,” stated Gretchen S Johnson, President and CEO, TRACT Therapeutics.

Orphan drug designation may be granted by the FDA to drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the U.S. on an annual basis. Orphan-drug designation provides certain incentives, which may include tax credits towards the cost of clinical trials and user fee waivers.


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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