FDA “Study May Proceed” Notice and IND Clearance Received for the Evaluation of TBS-2025 in Molecularly Defined Subsets of AML and Other Blood-Related Cancers
“As the only known company to advance a VISTA-inhibiting mAb through the FDA’s IND process into a Phase 1b study in mutNPM1 AML, this is a major milestone for the Company and a testament to our commitment to advancing novel therapies to address the unmet needs of patients with AML,” said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. “Research has shown that patients whose leukemic cells express VISTA have a poor response to therapy and significantly shorter survival. Studies have demonstrated that TBS-2025’s ability to block VISTA on leukemic cells has resulted in dramatic improvement in survival in studies of murine models of human AML, and we hope to translate this promising underlying science into a potentially safe and effective new treatment for patients with AML. We are excited for this next phase of our growth and by what it could mean for patients with AML.”
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