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Marker Therapeutics Reports Fiscal Year 2021 Operating and Financial Results
Enrollment of first 20 patients of the Company’s Phase 2 acute myeloid leukemia (AML) trial completed in Q4 2021 Topline readout of Group 2 active disease
About this update from Marker Therapeutics, Inc.
[{"type":"text","content":"Enrollment of first 20 patients of the Company’s Phase 2 acute myeloid leukemia (AML) trial completed in Q4 2021 Topline readout of Group 2 active disease anticipated in Q2 2022 Company plans to file INDs in lymphoma and pancreatic cancer by year end, with clinical trials to be initiated in 2023 HOUSTON, March 17, 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 provided a corporate update and reported financial results for the fiscal year ended December 31, 2021. “In 2021, we completed enrollment of the first 20 patients in our Phase 2 AML trial investigating our lead product candidate, MT-401,” said Peter L. Hoang, Marker’s President and Chief Executive Officer. “We also developed a new nine-day manufacturing process which increased the potency and antigen specificity and diversity of our products and significantly reduced the time it takes to manufacture our patient-specific T cell therapies. In February 2022, we reported initial results from the six-patient safety lead-in phase of the Phase 2 AML trial, which demonstrated that MT-401 was well-tolerated and satisfied the safety requirements with FDA. We expect to report topline data from the active disease group in the main phase of the Phase 2 trial next quarter. In addition, we look forward to expanding our pipeline beyond AML and expect to file INDs for lymphoma and pancreatic cancer by the end of the year.” PROGRAM UPDATES AND EXPECTED MILESTONES Acute Myeloid Leukemia (AML) MT-401 In February 2022, Marker announced the initial results of the safety lead-in stage of its Company-sponsored Phase 2 AML trial evaluating MT-401, Marker’s lead MultiTAA-specific T cell product candidate. Results from the safety lead-in demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) in one MRD positive patient and induced epitope spreading across multiple AML-associated antigens in that patient.The safety lead-in satisfied safety requirements with the FDA and the main Phase 2 stage of the AML trial began enrolling in July 2021.Enrollment of the first 20 patients of the Phase 2 AML trial was completed in Q4 2021.Topline readout of Group 2 ...