On March 3, 2021 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, reported it has treated the first patient in the Company’s Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate (Press release, TapImmune, MAR 3, 2021, View Source [SID1234576018]). The trial is enrolling patients with acute myeloid leukemia (AML) following an allogeneic stem cell transplant in both the adjuvant and active disease settings.
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"We are pleased to have dosed the first patient with MT-401 in our Company-sponsored clinical trial, particularly in a patient population in which there remains a critical unmet need," said Mythili Koneru, M.D., Ph.D., Chief Medical Officer of Marker Therapeutics. "Today, adult patients with post-transplant AML have a 25 percent chance of 5-year survival. In various investigator-sponsored Phase 1 trials at the Baylor College of Medicine, our MultiTAA-specific T cell therapies have been generally well-tolerated and demonstrated durable anti-cancer responses across a broad range of cancers—including post-transplant AML. Based on these results, we believe that MT-401 has the potential to become a meaningful treatment option for patients suffering from this disease."
About the AML Post-Transplant Study
Designed as a multicenter, Phase 2 trial to be conducted at approximately 20 top cancer centers across the U.S.
·Planned total enrollment of 160 patients:
-120 patients in the adjuvant disease group, randomized 1:1 to either MT-401 at 90 days post-transplant versus standard of care (observation)
-40 patients in the active disease group as part of a single arm
·Primary objective of relapse-free survival (RFS) for adjuvant disease group
·Primary objectives of complete response (CR) and duration of complete response (DOCR) for active disease group
·Topline readout of active disease group expected in Q1 2022