Actinium to Host Webinar on Iomab-ACT Trial with CAR T-Cell Therapy at UT Southwestern

Actinium Pharmaceuticals, Inc., a prominent developer of Antibody Radiation Conjugates (ARCs) and targeted radiotherapies, has announced a Key Opinion Leader (KOL) webinar scheduled for May 20, 2024, at 8:00 AM ET. The webinar will focus on updates regarding their newly launched clinical trial studying the Iomab-ACT in conjunction with a leading FDA-approved CAR-T cell therapy at the University of Texas Southwestern (UTSW). Iomab-ACT targets CD45, a marker present on blood cancer cells and immune cells, and aims to facilitate conditioning prior to cell and gene therapies, including CAR T-cell therapy, thereby potentially replacing the conventional non-targeted chemotherapy currently utilized for conditioning.

CAR-T cell therapies, which are approved for treating leukemias, lymphomas, and multiple myeloma, amassed over $3.5 billion in sales in 2023. Dr. Farrukh Awan, who specializes in the treatment of leukemia and lymphoma through CAR-T therapy and bone marrow transplantation, will serve as the principal investigator for the study led by UTSW.

Previously, Iomab-ACT has been examined in a clinical trial using an investigational CD19 targeting CAR-T cell therapy developed by Memorial Sloan Kettering Cancer Center (MSKCC) under a grant funded by the National Institutes of Health. The upcoming trial at UTSW marks the first instance of Iomab-ACT being studied with an FDA-approved CAR-T therapy.

The phase 1 trial results using Iomab-ACT as conditioning before administering CD19 CAR-T therapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) were presented at the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) in February 2024. Notably, none of the patients (0/4) developed immune effector cell-associated neurotoxicity syndrome (ICANS), a major safety measure of the study, and there was minimal occurrence of Cytokine Release Syndrome (CRS). Iomab-ACT also demonstrated temporary depletion of peripheral blood lymphocytes and monocytes, with persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities recorded.

There is a significant opportunity for improved conditioning methods in cellular therapy, including CAR-T and gene therapies. The pipeline for these therapies has expanded rapidly, with the patient population in the U.S. projected to nearly double to about 93,000 by 2030. The CAR-T market is expected to grow at a compound annual growth rate (CAGR) of approximately 11% over the next several years.

Currently, six FDA-approved CAR T-cell therapies are available to treat patients with lymphomas, leukemia, and multiple myeloma, collectively generating over $3.5 billion in sales in 2023. Iomab-ACT aligns well with the patient population requiring conditioning before cell and gene therapies. Actinium is dedicated to advancing Iomab-ACT, leveraging its early promising results to improve access and outcomes for patients needing cellular or gene therapies. Iomab-ACT holds the potential for significant revenue, assuming it demonstrates clinical benefits such as lower CRS, reduced ICANS, longer response duration with selective lymphodepletion, or higher overall success rates due to targeted conditioning benefits.

Actinium Pharmaceuticals, Inc. concentrates on developing targeted radiotherapies to enhance survival rates for individuals who have not responded to existing oncology treatments. Their advanced pipeline candidates include Iomab-B, an induction and conditioning agent before bone marrow transplants, and Actimab-A, a therapeutic agent, both of which have shown potential to extend survival outcomes for relapsed and refractory acute myeloid leukemia patients. Actinium plans to further develop Iomab-B for other blood cancers and continue advancing Iomab-ACT for cell and gene therapy enhancements. The company holds over 230 patents and applications, including several related to the cyclotron manufacture of the isotope Ac-225.