US-based biopharmaceutical company Targazyme has recruited the first patient in its Phase I/II clinical trial of TZ 101-treated regulatory T-cell (Tregs) to treat and prevent acute and chronic graft-versus-host-disease (GVHD) in stem cell transplants.
TZ101 is the company’s clinical-grade fucosyltransferase enzyme and small molecule product, which is available as off-the-shelf biologic products indicated to treat therapeutic cells immediately before administering it to the patient.
The Phase I/II clinical trial has been designed to evaluate the safety and efficacy of an ex-vivo treatment of Tregs addressing GVHD.
Targazyme CEO Lynnet Koh said: "The initiation of the Phase I/II study with TZ 101-treated regulatory T-cells in the stem cell transplant setting is an important clinical milestone for our evaluation of TZ101 as a potential treatment for patients suffering from GVHD and life-threatening autoimmune diseases."
According to the company, the new trial builds on available clinical data that TZ101 improves time to absolute neutrophil count and platelet recovery in patients undergoing hematopoietic stem cell transplants.
Both TZ101 and the company's second product TZ102 provides proof of concept that these products are enabling technologies for improving efficacy outcomes for various cells such as T cells, natural killer cells, and hematopoietic, cardiac and neural stem cells.
These are used to prevent and treat a variety of different diseases, for which there is a high unmet medical need.
GVHD is characterised by fatal complication of hematopoietic stem cell and solid organ transplantation, which is addressed by the regulatory T-cells and considered a key component of the immune system.