Marker Therapeutics, a Texas-based company, focuses on novel cell-based therapies for a variety of cancer indications. Marker proposes MT-401 for the treatment of acute myeloid leukemia (AML), supporting CPRIT’s mission for novel cancer treatments. AML is a deadly cancer, treated with chemotherapy, often followed by stem cell transplant (SCT). However, relapse after SCT remains a major cause of death, with poor 1-year survival. Limited treatments are available for patients who fail chemotherapy and SCT. MT-401 is a novel T cell-based therapy that targets multiple tumor-associated antigens (mTAAs) highly expressed in AML cancer cells (with absent / low expression in healthy tissue), minimizin...

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Marker Therapeutics, a Texas-based company, focuses on novel cell-based therapies for a variety of cancer indications. Marker proposes MT-401 for the treatment of acute myeloid leukemia (AML), supporting CPRIT’s mission for novel cancer treatments. AML is a deadly cancer, treated with chemotherapy, often followed by stem cell transplant (SCT). However, relapse after SCT remains a major cause of death, with poor 1-year survival. Limited treatments are available for patients who fail chemotherapy and SCT. MT-401 is a novel T cell-based therapy that targets multiple tumor-associated antigens (mTAAs) highly expressed in AML cancer cells (with absent / low expression in healthy tissue), minimizing the chance of tumor cells escaping treatment. MT-401 can recognize and kill target cancer cells, and leads to activation of other immune cells and recognition of additional cancer cells. mTAA T cells have shown safety and efficacy in preclinical and early phase clinical testing in a multiple cancer types, including AML. In this CPRIT proposal, Marker will conduct a Phase 2 clinical trial of MT-401 in AML patients post-SCT in the adjuvant setting (in remission, at risk of relapse). 60 AML patients will be treated with MT-401 and compared with patients treated with standard of care to assess safety, efficacy, and immune effects. Completion of this trial will advance MT-401 towards market approval and provide a safe, effective treatment option where none currently exists on the market.

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