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Marker Therapeutics Reports Q3 2022 Operating and Financial Results
Company awarded $2 million U.S. FDA Orphan Products Grant to support Phase 2 ARTEMIS trial of its lead T cell therapy candidate MT-401 in patients with
About this update from Marker Therapeutics, Inc.
[{"type":"text","content":"Company awarded $2 million U.S. FDA Orphan Products Grant to support Phase 2 ARTEMIS trial of its lead T cell therapy candidate MT-401 in patients with post-transplant AML\nHOUSTON, Nov. 10, 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 third quarter ended September 30, 2022. “This quarter we reached a major milestone in treating the first six patients in our Phase 2 AML trial with T cells derived from our new manufacturing process, which are designed for increased potency against tumor antigens,” said Peter L. Hoang, Marker’s President and Chief Executive Officer. “We are also pleased to receive a grant from the FDA Orphan Products program to support the Phase 2 treatment arm evaluating MT-401 in patients with minimal residual disease. We believe the MRD-positive patient population represents a significant opportunity for MT-401 as we continue to dose more patients in the trial and measure long-term response.” PROGRAM UPDATES AND EXPECTED MILESTONES Acute Myeloid Leukemia (MT-401) In September 2022, Marker announced that it had been awarded a $2 million grant from the U.S. Food and Drug Administration (FDA) Orphan Products Grants program to support the Phase 2 ARTEMIS trial of the company’s lead multi-tumor-associated antigen (MultiTAA) T cell product candidate, MT-401, in patients with post-transplant AML. 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.The Company has treated all six patients in Cohorts 4 and 5 using MT-401 manufactured with Marker’s new T cell manufacturing process. The new manufacturing process is designed to produce a more potent product with increased antigen specificity and diversity and a reduction in manufacturing time. To date, all six patients have completed dose-limiting toxicity (DLT) periods with no DLTs reported. The Company expects to announce an efficacy analysis from the six patients in...