Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced FDA clearance for an IND application to study Iomab-ACT for targeted conditioning prior to bone marrow transplant (BMT) in sickle cell disease patients. The study, in collaboration with Columbia University, aims to evaluate Iomab-ACT's safety and potentially inform future gene therapy conditioning trials. Iomab-ACT, an Antibody Radiation Conjugate targeting CD45, could replace current non-targeted chemotherapy and total body irradiation conditioning methods, potentially reducing severe side effects and broadening access to curative cellular therapies. This initiative addresses the high unmet need among approximately 100,000 U.S. sickle cell patients annually. The study aligns with Actinium's strategy to expand Iomab-ACT's applications in transplant, cell therapy, and gene therapy conditioning, tapping into a growing market for CAR-T and gene therapies expected to reach 93,000 U.S. patients by 2030.
Actinium Pharmaceuticals announced that the Phase 3 SIERRA trial results of Iomab-B will be presented at the EHA 2024 Congress. The trial demonstrated significant survival benefits in older patients with relapsed or refractory acute myeloid leukemia (r/r AML) receiving an Iomab-B led bone marrow transplant (BMT). Patients with TP53 mutations saw a median overall survival of 5.49 months compared to 1.66 months for those not receiving Iomab-B. The trial enrolled high-risk patients and showed 92% 1-year survival and 69% 2-year survival rates in those receiving Iomab-B led BMT.
Actinium Pharmaceuticals, Inc. announced a KOL webinar to discuss its Iomab-ACT trial with a leading FDA approved CAR T-cell therapy at the University of Texas Southwestern. The webinar will highlight the potential billion-dollar market opportunity in lymphodepletion. Dr. Farrukh Awan will lead the trial, aiming to study Iomab-ACT with an FDA approved CAR-T cell therapy for the first time. The company presented positive phase 1 trial results at the Tandem Meetings, showing promising safety and efficacy profiles. With the expanding CAR-T market and the need for improved conditioning in cellular therapy, Iomab-ACT presents a revenue opportunity in line with the growing patient population for cell and gene therapies.
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