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Marker Therapeutics Awarded $2 Million Grant from U.S. FDA to Support Marker’s Phase 2 ARTEMIS Trial of MT-401 in Post-Transplant AML
Award to fund clinical study of Marker’s multi-antigen targeted T cell therapy for the treatment of post-transplant AML patients with minimal residual disease
About this update from Marker Therapeutics, Inc.
[{"type":"text","content":"Award to fund clinical study of Marker’s multi-antigen targeted T cell therapy for the treatment of post-transplant AML patients with minimal residual disease\nHOUSTON, Sept. 13, 2022 (GLOBE NEWSWIRE) -- 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 Company has been awarded a $2 million grant from the U.S. Food and Drug Administration (FDA) Orphan Products Grants program to support its Phase 2 ARTEMIS trial of its lead multi-tumor-associated antigen (MultiTAA) T cell product candidate, MT-401, in patients with post-transplant acute myeloid leukemia (AML). The FDA grant will support the Company’s treatment arm evaluating MT-401 in patients with post-transplant AML with minimal residual disease. MT-401 was granted Orphan Drug Designation for the treatment of patients with AML following allogeneic stem cell transplant in 2020. \"We are pleased to receive this Orphan Products award from the FDA to further clinical development of our multi-antigen targeted T cell therapy in AML, a rare disease with limited treatment options after a stem cell transplant,\" said Dr. Mythili Koneru, Marker’s Chief Medical Officer. “In our Phase II ARTEMIS study for patients with post-transplant AML, we have observed promising results amongst the MRD+ patients, suggesting that MT-401’s unique and differentiated targeting technology can potentially reach MRD positive patients before relapse. This grant will enable us to further advance our development of MT-401 to potentially treat a patient population where no treatments have been approved. We look forward to further exploration in this patient population.” About Marker's Phase 2 ARTEMIS Trial The multicenter Phase 2 AML study is evaluating the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease setting. In the adjuvant setting, approximately 120 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus standard-of-care observation, while approximately 40 patients with active disease will receive MT-401 as part of the single-arm group. The primary objectives of the trial are to evaluat...