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FDA grants fast track designation to T-Guard for acute graft-versus-host disease
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The FDA granted fast track designation to T-Guard for treatment of patients who develop steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation.
T-Guard (Xenikos) consists of two toxin-conjugated monoclonal antibodies that target CD3 and CD7 on T cells and natural killer cells.
Preclinical and early clinical studies showed the agent can identify and eliminate mature T cells and natural killer cells with minimal treatment-related side effects, according to a Xenikos-issued press release.
A phase 1/phase 2 study evaluated T-Guard as second-line treatment of steroid-refractory acute GVHD among patients who underwent hematopoietic stem cell transplantation. Results showed 1 week of T-Guard treatment doubled the 6-month OS and induced a strong clinical response, according to the release.
Xenikos is preparing to begin a pivotal phase 3 trial of T-Guard for steroid-refractory acute GVHD after allogeneic stem cell transplant.
“We are delighted that the FDA has given fast track designation to T-Guard, as this will support our goal of getting T-Guard to patients as quickly as possible,” Ypke van Oosterhout, PhD, CEO of Xenikos, said in the press release. “We’re also looking forward to starting our phase 3 pivotal trial in the U.S. Effective new therapies for treating steroid-refractory acute GVHD are urgently needed, and we believe that T-Guard — which can rapidly and safely reset the patient’s immune system — has the potential to provide an important new treatment option to patients with this devastating, potentially fatal condition.”