Actinium Pharmaceuticals(ATNM) 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, aiming to assess the rate and duration of Complete Remission (CR) and safety [1][2] - Actimab-A is a humanized anti-CD33 antibody conjugated to Actinium-225, targeting CD33, which is expressed on myeloid blasts in AML patients [1][4] - The triplet regimen is designed for outpatient administration, as both Venetoclax and ASTX-727 are oral agents, and Actimab-A does not require patient isolation [2][3] Group 2: Mechanism and Efficacy - 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][3] - Previous studies indicated that Actimab-A in combination with Venetoclax was well tolerated, with manageable adverse events, and preclinical studies suggested a synergistic effect by depleting MCL-1, which mediates resistance to Venetoclax [2][5] Group 3: Strategic Vision and Market Potential - The company aims to establish Actimab-A as a backbone therapy for AML and other myeloid malignancies, leveraging the broad expression of CD33 and the mutation agnostic nature of Ac-225 [3][4] - Actinium anticipates generating preclinical data and initiating additional clinical trials throughout 2025 to further differentiate Actimab-A and demonstrate its potential as a first-in-class radiotherapy for over 100,000 AML patients in the U.S. and other major markets [3][4]