Business
Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Acute Myeloid Leukemia
HOUSTON, April 29, 2020 /PRNewswire/ -- Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of
About this update from Marker Therapeutics, Inc.
[{"type":"text","content":"HOUSTON, April 29, 2020 /PRNewswire/ -- Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development 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. \n\n \n \n \n \n \n \n\n \n\"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.\nOrphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax credits, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. For more information about orphan designation, please visit the FDA website at www.fda.gov.\nAbout Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of he...