Frontline(FRO) Prnewswire·2025-03-11 12:30Core Viewpoint - Actinium Pharmaceuticals has initiated the first clinical trial for Actimab-A under a Cooperative Research and Development Agreement with the National Cancer Institute, focusing on a triplet combination therapy for acute myeloid leukemia (AML) patients [1][2][3] Group 1: Clinical Trial Details - The trial (NCT06802523) will evaluate the combination of Actimab-A, Venetoclax, and ASTX-727 in frontline AML patients [1] - Actimab-A is a humanized anti-CD33 antibody conjugated to Actinium-225, targeting CD33, which is expressed on myeloid blasts in AML [1] - The study aims to assess the rate and duration of Complete Remission (CR) and safety, including the optimal dose of Actimab-A [1] Group 2: Mechanism and Benefits - Actimab-A's mechanism is mutation agnostic, potentially improving outcomes for patients with high-risk features, such as TP53 mutations, where current therapies have limited success [2] - The triplet regimen can be administered conveniently in an outpatient setting, as both Venetoclax and ASTX-727 are oral agents [2] - Preclinical studies indicate that Actimab-A can synergize with Venetoclax by depleting MCL-1, which mediates resistance to Venetoclax [2] Group 3: Company Vision and Market Potential - The company anticipates 2025 to be a transformational year, aiming to establish Actimab-A as a backbone therapy for AML and other myeloid malignancies [3] - Actinium is focused on addressing the high unmet medical needs in AML, with over 100,000 patients in the U.S. and other major markets [3][5] - The triplet combination represents the first-ever use of targeted radiotherapy as a backbone therapy in AML, with initial clinical data expected in the second half of 2025 [5]