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Marker Therapeutics Announces FDA Clearance of IND for MT-601, its Six-Antigen T Cell Therapy for the Treatment of Pancreatic Cancer
HOUSTON, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development
About this update from Marker Therapeutics, Inc.
[{"type":"text","content":"HOUSTON, Nov. 22, 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 U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MT-601, a multi-tumor-associated antigen (multiTAA)-specific T cell product targeting six antigens, for the treatment of patients with locally advanced unresectable or metastatic pancreatic cancer in combination with front-line chemotherapy. “Based on the encouraging results seen in the Phase 1 TACTOPS study conducted by our partners at Baylor College of Medicine, we are eager to initiate a Marker-sponsored Phase 1 clinical trial next year,” said Dr. Mythili Koneru, Marker’s Chief Medical Officer. “Interim results from the TACTOPS study presented at ASCO in 2020 showed that treatment with multiTAA therapy in combination with front-line standard-of-care chemotherapy resulted in clinical responses greater than expected with chemotherapy alone. We look forward to investigating MT-601, a potentially more potent multiTAA-specific T cell therapy product that targets six antigens found on pancreatic cancer tumor cells, in a similar patient population.” Marker intends to initiate a multicenter Phase 1 trial for the treatment of patients with locally advanced unresectable or metastatic pancreatic cancer in combination with front-line chemotherapy in 2023. Compared to the TACTOPS study, Marker is using a new, streamlined manufacturing process for MT-601. This new manufacturing process has already demonstrated major improvements to MT-401, Marker’s multiTAA-specific T cell product for AML. The new manufacturing process allows production in 9 days compared to the original process of >30 days. This is accompanied by a 90% decrease in the number of interventions during production and an improved final T cell product versus the original product in the TACTOPS trial. Marker’s IND for MT-601 for the treatment of pancreatic cancer reflected this improved manufacturing process. “The FDA’s clearance of our IND for MT-601 is a significant milestone for Marker as we prepare for our third planned clinical trial evaluating our multiTAA-spe...