Multi-Antigen Targeted T Cell Therapy for Acute Myeloid Leukemia Receives Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to MT-401, a multi-tumor-associated antigen (MultiTAA)-specific T cell product for the treatment of patients with acute myeloid leukemia (AML), following allogeneic stem cell transplant, according to a press release.

“We are pleased that the FDA has granted orphan designation to MT-401, our novel MultiTAA-specific T cell product candidate and believe it is supportive of its potential to treat post allogeneic stem cell transplant patients with AML—a devastating and pervasive blood disease with a high medical need for a treatment. In investigator-sponsored trials, our MultiTAA-specific T cell product candidate 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. We look forward to initiating our Company-sponsored Phase 2 study in patients with post allogeneic stem cell transplant AML,” said Peter L. Hoang, President & CEO of Marker Therapeutics in the press release.

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