Actinium Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its intellectual property portfolio around its lead Phase 3 candidate, I-131 apamistamab (Iomab-B), has been further strengthened internationally after the company received a European patent for the composition and methods of administration of Iomab-B, the company’s Antibody-radiation Conjugate (ARC) which combines the targeting ability of apamistamab, a CD45 targeting antibody linked to the radioisotope iodine-131.

The issued patent in the European Union is expected to have a useful life through 2036. In addition, Actinium has been granted a patent covering the same composition and methods of administration claims in Japan.

“We are excited to expand our already robust patent portfolio with these key patents in the EU and Japan,” noted Dale Ludwig, Ph.D., Actinium’s Chief Scientific Officer.

“As the only CD45 ARC for targeting conditioning in clinical development, these international patents, together with our U.S. patents lay the foundation for aggressive development of Iomab-B for Bone Marrow Transplant (BMT) conditioning and Iomab-ACT for conditioning prior to cell and gene therapies. Iomab-B is well characterized and supported by extensive clinical data across multiple clinical trials and indications,” Ludwig explained.

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“Our ARC approach has significant advantages over other approaches such as monoclonal antibodies or antibody-drug conjugates that require payload internalization, making them impractical for targeting CD45. We look forward to continuing to build our leadership position in targeted conditioning led by Iomab-B and remaining at the forefront of innovation in targeted radiotherapy,” he concluded.

Pending patents
Actinium owns issued or pending patents within the United States and globally covering composition of matter, formulation, methods of use, and methods of administration with potential coverage for 19 years or longer.  In addition, Actinium owns an issued patent in the US covering the composition of matter, for which the company expects validity until 2037.  Actinium also owns a second US patent that further covers the composition of matter, methods of use, and methods of administration for Iomab-B.

“We are delighted to now have wholly-owned issued patents in the U.S. and EU and a granted patent in Japan covering the composition and methods of Iomab-B, as these three regions represent an overwhelming majority of the global addressable market for Iomab-B,” said Sandesh Seth, Actinium’s Chairman, and Chief Executive Officer.

“We have been aggressively building our patent portfolio and it is a major accomplishment to have IP protection on our lead asset into 2036 and 2037. In addition to IP protection, we also have orphan drug designation for Iomab-B in the U.S. and EU, providing potential market exclusivity. As we look to the future, our IP portfolio gives us great confidence in our ability to build the leading, multi-indication strategic business unit for the large and growing targeted conditioning market on a global scale,” Seth concluded.

Clinical development
Actinium’s lead product candidate, Iomab-B is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning.  The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility, and safety data have been highlighted at ASH, TCT, ASCO, and SOHO annual meetings.

Clinical trial
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) – NCT02665065 Trial Info

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