Actinium Pharmaceuticals announced that the University of Texas Southwestern Medical Center will lead a clinical trial studying Actinium’s Iomab-ACT, a targeted radiotherapy conditioning agent prior to patients receiving an FDA approved commercial CAR T-cell therapy. UT Southwestern will start recruiting patients following FDA’s review and clearance of the study. Currently, there are six CAR-T therapies approved to treat patients with leukemias, lymphomas and multiple myeloma that collectively reached sales in 2023 exceeding $3.5B. Early clinical data with Iomab-ACT conditioning prior to CAR-T demonstrates its ability to produce targeted lymphodepletion along with negligible incidences of immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome, which are the major toxicities observed with the current chemotherapy based conditioning regimens. Actinium presented results from its ongoing phase 1 trial using Iomab-ACT as conditioning prior to CD19 CAR-T therapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia or Diffuse Large B-cell Lymphoma in February. None of the 4 patients developed immune effector cell-associated neurotoxicity syndrome of any grade. Iomab-ACT demonstrated transient depletion of peripheral blood lymphocytes and monocytes. The CAR-T market size in terms of revenue is estimated to grow at a CAGR of approximately 11% over the next 5 plus years.
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