The Dutch company Xenikos B.V. said FDA has granted Fast Track designation to T-Guard, Xenikos’s product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
T-Guard is designed to reset the body’s immune system in life-threatening T cell-mediated conditions, including transplant-related rejection, acute solid-organ rejection, and severe autoimmune disease. T Guard consists of a combination of toxin-conjugated monoclonal antibodies that target CD3 and CD7 molecules on T cells and NK cells.
Preclinical and early clinical testing have shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with minimal treatment-related side effects, the company said. T-Guard’s action is short-lived, thereby significantly reducing the patient’s vulnerability to opportunistic infections, compared to currently available therapies. Xenikos has completed a phase I/II study for the second-line treatment of SR-aGVHD in patients following hematopoietic stem cell transplantation.
The results of the study showed that one week of T-Guard treatment triggered a strong clinical response and doubled the 6-month overall survival rate, the company said. These results were published in Biology of Blood and Marrow Transplantation.
A U.S. phase III registration trial involving patients with SR-aGVHD following allogeneic stem cell transplantation will begin soon, and T-Guard has been granted Fast Track designation by the FDA, as well as Orphan Drug Designation status in both the EU and the U.S.
