Actinium Extends Patent for Iomab-ACT in Gene-Edited Stem Cell Therapies

Actinium Pharmaceuticals, Inc. has announced the issuance of U.S. Patent No. 11,912,780 by the United States Patent and Trademark Office (USPTO). This patent, titled "Anti-CD45-Based Conditioning Methods and Uses Thereof in Conjunction with Gene-Edited Cell Based Therapies," provides protection until 2040 and pertains to methods of using Iomab-ACT for conditioning patients before administering gene-edited hematopoietic stem cell (HSC) therapy. This application of Iomab-ACT is intended for the treatment of non-malignant disorders such as sickle cell disease, severe combined immunodeficiency disease (SCID), β-thalassemia, and Fanconi's anemia.

Iomab-ACT is an Antibody Radiation Conjugate (ARC) designed to target CD45, a marker found on blood cancer cells and immune cells. This targeted approach aims to prepare patients for cell and gene therapies, such as CAR T-cell therapy, by replacing the traditional non-targeted chemotherapy used in conditioning. The traditional chemotherapy-based regimens often involve high doses of cytotoxic drugs, like busulfan, which are associated with severe side effects, including infertility. Iomab-ACT offers a more targeted and potentially less toxic alternative.

Sandesh Seth, Actinium's Chairman and CEO, highlighted the rapid evolution of gene-edited stem cell therapies and their potential to transform or cure debilitating diseases. He emphasized the company's commitment to innovation in targeted radiotherapy, aiming to establish Iomab-ACT as a universal, non-chemotherapy conditioning regimen for both malignant and non-malignant conditions. Seth pointed out that the diseases targeted by this patent affect over one hundred thousand patients annually, underscoring the importance of improving access and outcomes via Iomab-ACT. The company's recent clinical collaborations with leading academic institutions demonstrate their commitment to exploring the potential of Iomab-ACT as a conditioning regimen before cellular therapy.

The newly issued patent extends Actinium's intellectual property portfolio, which also includes composition of matter patents for Iomab-B and Iomab-ACT, with coverage lasting until 2037. The term of the new patent protection for Iomab-ACT extends to 2040. Actinium is also pursuing additional patent coverage for Iomab-ACT both in the U.S. and internationally.

Currently, Iomab-ACT is being tested in a clinical trial at Memorial Sloan Kettering Cancer Center. This trial involves a CD19 CAR-T therapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL). The trial has received funding from the National Institutes of Health (NIH). Initial proof-of-concept data have shown that Iomab-ACT induces a transient depletion of peripheral blood lymphocytes and monocytes, with CAR-T cells persisting up to eight weeks post-infusion. Importantly, no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, a major safety concern in CAR-T cell therapies, which typically see ICANS in 25% or more of treated patients.

Iomab-ACT is also under investigation in a Phase 1 trial in collaboration with the University of Texas Southwestern (UTSW) as a conditioning therapy before commercial CAR-T treatment. Another Phase 1 trial is being conducted with Columbia University to condition patients with sickle cell disease prior to a stem cell transplant, with the goal of informing a future gene therapy conditioning trial for sickle cell disease. The FDA has cleared IND applications for both the commercial CAR-T and sickle cell disease Phase 1 trials, with patient enrollment expected to begin soon.

Actinium Pharmaceuticals focuses on developing targeted radiotherapies to significantly improve survival rates for patients who have not responded to existing oncology treatments. Their advanced pipeline includes Iomab-B, an induction and conditioning agent for bone marrow transplants, and Actimab-A, a therapeutic agent for relapsed and refractory acute myeloid leukemia. Actinium holds over 230 patents and patent applications, including several related to the production of the isotope Ac-225 in a cyclotron.

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