Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program

Core Insights - Marker Therapeutics has initiated the Phase 1 RAPID study to evaluate the safety and efficacy of its Off-the-Shelf (OTS) multi-antigen recognizing (MAR) T cell product, MT-401, targeting four antigens in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) [1][2][8] - The first patient has been treated with the OTS product, showing promising preliminary safety data with no treatment-related adverse events reported [2][3] - The OTS program aims to expedite treatment by utilizing commercially available leukapheresis material, potentially allowing for treatment initiation within 72 hours and reducing manufacturing costs [3][4] Company Overview - Marker Therapeutics is a clinical-stage immuno-oncology company based in Houston, TX, focusing on next-generation T cell-based immunotherapies for hematological malignancies and solid tumors [9] - The company has a strong foundation in research and development, having conducted clinical trials with over 200 patients, demonstrating the tolerability and durable clinical responses of its MAR-T cell products [9] Funding and Support - The OTS program is supported by non-dilutive funding from the FDA, NIH Small Business Innovation Research (SBIR) program, and the Cancer Prevention and Research Institute of Texas (CPRIT), allowing the company to advance its clinical investigations without affecting its financial runway [3][8] Scientific Basis - The MAR-T cell platform is a novel, non-genetically modified cell therapy that selectively expands tumor-specific T cells capable of recognizing a broad range of tumor antigens, potentially reducing the risk of tumor escape [6][7] - The OTS product, MT-401-OTS, targets four tumor antigens (Survivin, PRAME, NY-ESO-1, WT-1) and is currently being investigated in a multicenter, open-label trial [8]