Actinium Pharmaceuticals, Inc. announced it will host a KOL call on May 20, 2024, at 8:00 AM ET to provide updates and highlight its recently announced clinical trial to study Iomab-ACT with a leading FDA approved CAR-T cell therapy at the University of Texas Southwestern (UTSW). Iomab-ACT is an ARC that targets CD45, a marker expressed on blood cancer cells and immune cells that is intended to enable conditioning prior to cell and gene therapies such as CAR T-cell therapy and replace the non-targeted chemotherapy that is currently used for conditioning. There are six CAR-T cell therapies approved to treat patients with leukemias, lymphomas and multiple myeloma that collectively reached sales in 2023 exceeding $3.5 billion.

Dr. Farrukh Awan specializes in the treatment of patients with leukemia and lymphoma including CAR-T therapy and bone marrow transplantation. Dr. Awan will serve as principal investigator for this study that will be led by UTSW. To date, Iomab-ACT has been studied in a clinical trial with an investigational CD19 targeting CAR-T cell therapy developed by Memorial Sloan Kettering Cancer Center (MSKCC) under a National Institutes of Health funded grant.

The trial at UTSW will be the first trial to study Iomab-ACT or any targeted radiotherapy conditioning agent with an FDA approved CAR-T therapy. 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 (B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) at the Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR 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. Importantly, no patients (0/4) developed immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, a major safety measure of the study and minimal Cytokine Release Syndrome (CRS).

ICANS is observed in 25% or more of pts w/R/R B-ALL and DLBCL treated with various currently approved CAR T-cell products. Iomab-ACT demonstrated transient depletion of peripheral blood lymphocytes and monocytes. Persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities have been observed to date.

The opportunity exists for better conditioning in other areas of cellular therapy, such as CAR-T as well as gene therapies. The pipeline of CAR-T and gene therapies has rapidly expanded, with the addressable patient population expected to nearly double and reach approximately 93,000 patients in the U.S. by 2030 based on the current pipeline of cellular therapies. 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.

Currently, there are six CAR T-cell therapies approved by the FDA that are used to treat patients with lymphomas, leukemia, and multiple myeloma, which collectively had total sales of over $3.5 billion in 2023. The addressable market for Iomab-ACT is in line with the patient population for cell and gene therapies as all patients must receive some type of conditioning prior to these treatments.