FDA Grants Orphan Drug Designation to MT-401 for AML

The FDA has granted orphan drug designation to MT-401, an allogeneic T-cell therapy for the treatment of acute myeloid leukemia (AML).

MT-401, from Marker Therapeutics, is an investigational, multi-tumor-associated antigen-specific T-cell therapy. The FDA’s designation clears the drug to begin a phase II clinical trial of patients with AML after allogeneic stem cell transplantation.

“In investigator-sponsored trials, [MT-401] was well-tolerated and we have observed clinical benefit across various liquid and solid tumors, suggesting the product candidate’s ability to induce a patient’s own T cells to expand for a more durable anti-tumor effect,” said Peter L. Hoang, President and CEO of Marker Therapeutics.

Source: Marker Therapeutics press release, April 29, 2020.