Singulera Therapeutics

Singulera Therapeutics, formerly known as TRACT Therapeutics, is a clinical-stage biotechnology company specialized in developing regulatory T cell (Treg) therapies to restore immune balance. The company's proprietary technology platform utilizes autologous polyclonally expanded Tregs to treat solid organ transplant recipients and patients with autoimmune disorders. Its lead candidate, TRK-001 (also known as TregCel), is currently in Phase 2 clinical trials for the prevention of kidney transplant rejection, aiming to establish immune tolerance and reduce or eliminate the need for life-long immunosuppressive drug therapy. In 2025, Singulera was acquired by Taiwan Bio Therapeutics to accelerate its global manufacturing capabilities and expand its pipeline into next-generation Treg applications. The company maintains strong academic ties with Northwestern University, where its foundational technology was originally developed.