On September 13, 2022 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, reported 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) (Press release, Marker Therapeutics, SEP 13, 2022, View Source [SID1234619501]).
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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 evaluate relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease patients. Additional objectives include, for the adjuvant group, overall survival and graft-versus-host disease relapse-free survival while additional objectives for the active disease group include overall response rate, duration of response, progression-free survival and overall survival.
About the U.S. FDA Orphan Products Grants Program
The FDA’s Orphan Products Grants Program awards grants to clinical investigators to support the development of safe and effective medical products for patients with rare diseases. The program has supported clinical research since 1983 and has funded clinical trials that have facilitated the approval of more than 70 products.