Actinium Expands Patent Coverage Over Iomab-ACT, its Next-Generation Targeted Radiotherapy Conditioning Agent, for Gene Edited Stem Cell-Based Therapies for Non-Malignant Indications

Rhea-AI Summary

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has expanded its patent coverage for Iomab-ACT, a targeted radiotherapy conditioning agent, with the issuance of U.S. Patent No. 11,912,780. This patent, extending to 2040, covers methods using Iomab-ACT for conditioning patients before gene-edited hematopoietic stem cell therapy for non-malignant disorders such as sickle cell disease, SCID, β-thalassemia, and Fanconi's anemia.

Iomab-ACT targets CD45, aiming to replace non-targeted chemotherapy in conditioning for cell and gene therapies. The company is conducting clinical trials with Memorial Sloan Kettering Cancer Center, the University of Texas Southwestern, and Columbia University to explore Iomab-ACT's potential in various applications, including CAR-T therapy and sickle cell disease treatment.

Positive

• Expanded patent coverage for Iomab-ACT until 2040
• Potential application in treating multiple non-malignant disorders
• Ongoing clinical trials with prestigious institutions
• Initial proof of concept data showed promising results with minimal toxicities

Negative

• None.

Insights

Biotech Patent Analyst

The issuance of U.S. Patent No. 11,912,780 for Actinium's Iomab-ACT is a significant development in the field of targeted radiotherapy conditioning for gene-edited stem cell therapies. This patent, extending to 2040, strengthens Actinium's intellectual property portfolio in a rapidly evolving and potentially lucrative market.

Key points to consider:

• The patent covers methods using Iomab-ACT for conditioning patients prior to gene-edited hematopoietic stem cell therapy for non-malignant disorders, including sickle cell disease, SCID, β-thalassemia and Fanconi's anemia.
• This expansion into non-malignant indications broadens Iomab-ACT's potential market, targeting over 100,000 patients annually.
• The patent complements Actinium's existing composition of matter patents for Iomab-B and Iomab-ACT, which extend to 2037.

From an investor's perspective, this patent issuance enhances Actinium's competitive position in the targeted radiotherapy space. It provides a longer exclusivity period for Iomab-ACT, potentially increasing its commercial value. However, it's important to note that patent issuance doesn't guarantee market success; clinical trial outcomes and regulatory approvals will be important for realizing the technology's full potential.

Oncology Research Specialist

Actinium's Iomab-ACT represents a potentially groundbreaking approach to patient conditioning for cell and gene therapies. The key advantages of this targeted radiotherapy approach include:

• Potential replacement of non-targeted chemotherapy, which is associated with significant toxicities.
• Targeting CD45, a marker expressed on blood cancer cells and immune cells, allowing for more precise conditioning.
• Possible reduction in fertility-related side effects, a major concern for patients with non-malignant conditions seeking gene therapy.

Early clinical data from the Memorial Sloan Kettering Cancer Center trial is promising, showing:

• Transient depletion of peripheral blood lymphocytes and monocytes
• CAR-T cell persistence up to eight weeks post-infusion
• Minimal non-hematologic toxicities
• Notably, no cases of ICANS (immune effector cell-associated neurotoxicity syndrome) observed in the initial cohort, compared to a typical incidence of 25% or higher with current CAR-T therapies

These early results suggest Iomab-ACT could potentially improve the safety profile of cell and gene therapies, which could be a significant advantage in both malignant and non-malignant indications. However, larger studies are needed to confirm these initial findings and demonstrate efficacy across various indications.

Financial Analyst

Actinium's patent expansion for Iomab-ACT presents several financial implications:

• Market Expansion: The inclusion of non-malignant indications significantly broadens the potential patient pool, potentially increasing Iomab-ACT's market value.
• Extended Exclusivity: Patent protection until 2040 provides a longer runway for potential commercialization and revenue generation.
• Competitive Advantage: The patent strengthens Actinium's position in the targeted radiotherapy space, potentially attracting partnerships or acquisition interest.
• Diversification: Expanding into non-malignant indications reduces reliance on oncology markets, potentially stabilizing future revenue streams.

However, investors should consider:

• Development Costs: Expanding into new indications will require additional clinical trials, increasing R&D expenses.
• Regulatory Hurdles: Approval processes for non-malignant indications may differ from oncology, potentially extending time to market.
• Competition: The gene therapy field is rapidly evolving and other conditioning approaches may emerge.

While the patent news is positive, Actinium's financial success will ultimately depend on clinical trial outcomes, regulatory approvals and successful commercialization. The company's ability to secure partnerships or additional funding to support these expanded development programs will be important to watch.

-       Newly issued U.S. patent augments Actinium's existing composition of matter patent coverage over Iomab-B and Iomab-ACT targeted radiotherapy conditioning programs

-       Pertains to the use of Iomab-ACT with genetically engineered hematopoietic stem cells for treating non-malignant diseases including sickle cell disease, severe combined immunodeficiency disease, β-thalassemia and Fanconi's anemia

NEW YORK, Aug. 1, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced the issuance of U.S. Patent No. 11,912,780 titled, "Anti-CD45-Based Conditioning Methods and Uses Thereof in Conjunction with Gene-Edited Cell Based Therapies" by the United States Patent and Trademark Office (USPTO). This patent extends into 2040 and covers methods using Iomab-ACT for conditioning patients prior to the administration of gene-edited hematopoietic stem cell (HSC) therapy to treat non-malignant disorders, such as sickle cell disease, severe combined immunodeficiency disease (SCID), β-thalassemia and Fanconi's anemia. 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. 

Sandesh Seth, Actinium's Chairman and CEO, stated, "The field of gene-edited stem cell therapies is rapidly evolving, with the potential to transform or even cure debilitating diseases. Recognizing this emerging field, we are excited to further strengthen our intellectual property portfolio, demonstrating our commitment to innovation in targeted radiotherapy. We aim to establish Iomab-ACT as a universal, non-chemotherapy targeted conditioning regimen for use across cell and gene therapies for both malignant and non-malignant indications. Current conditioning regimens use high doses of cytotoxic chemotherapies such as busulfan and others that are associated with infertility and other toxicities posing barriers for patients seeking gene therapy for non-cancerous diseases. Collectively, the indications covered under this patent afflict over one hundred thousand patients each year, and we are committed to improving access and outcomes for these patients via Iomab-ACT as is evidenced by our recent clinical collaborations with leading academic institutions to determine the potential of Iomab-ACT as a conditioning regimen prior to a cellular therapy".

Actinium's intellectual property portfolio also includes a family of issued composition of matter patents covering Iomab-B and Iomab-ACT, extending into 2037. The term of newly issued U.S. Patent No. 11,912,780 extends patent protection over Iomab-ACT aspects until 2040. The Company is pursuing further patent coverage for Iomab-ACT in the U.S. and internationally.

Iomab-ACT is currently being studied in a clinical trial at Memorial Sloan Kettering Cancer Center with a CD19 CAR-T therapy in patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) that is supported by grant funding from the National Institutes of Health (NIH). Initial proof of concept data showed that Iomab-ACT produced transient depletion of peripheral blood lymphocytes and monocytes and that CAR-T cells persisted up to eight weeks post infusion. Minimal non-hematologic toxicities have been observed to date. Specifically, there were no (0/4) cases of immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, a major safety measure of the study, as ICANS is observed in 25% or more of patients with r/r B-ALL and DLBCL treated with various CAR-T cell products. Iomab-ACT is being studied in a Phase 1 trial as conditioning prior to treatment with a commercial CAR-T therapy in collaboration with the University of Texas Southwestern (UTSW) as well as a Phase 1 trial to condition patients with sickle cell disease prior to a stem cell transplant in collaboration with Columbia University that is expected to inform a gene therapy conditioning trial in patients with sickle cell disease. IND applications have been cleared by the FDA for both the commercial CAR-T and sickle cell disease Phase 1 trials and patient enrollment is expected to commence.

About Actinium Pharmaceuticals, Inc.

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA & MAA (EU)), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute), a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium holds more than 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron.

For more information, please visit: https://www.actiniumpharma.com/

Forward-Looking Statements

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Investors:
investorrelations@actiniumpharma.com 

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SOURCE Actinium Pharmaceuticals, Inc.

FAQ

What is the new patent issued to Actinium Pharmaceuticals (ATNM) for?

Actinium Pharmaceuticals (ATNM) has been issued U.S. Patent No. 11,912,780, which covers methods using Iomab-ACT for conditioning patients prior to gene-edited hematopoietic stem cell therapy for non-malignant disorders.

What conditions can Iomab-ACT potentially treat according to Actinium's new patent?

According to the new patent, Iomab-ACT can potentially be used for conditioning patients with non-malignant disorders such as sickle cell disease, severe combined immunodeficiency disease (SCID), β-thalassemia, and Fanconi's anemia.

What clinical trials is Actinium (ATNM) currently conducting for Iomab-ACT?

Actinium (ATNM) is conducting clinical trials for Iomab-ACT with Memorial Sloan Kettering Cancer Center for CAR-T therapy, University of Texas Southwestern for conditioning prior to commercial CAR-T therapy, and Columbia University for conditioning patients with sickle cell disease prior to stem cell transplant.

What were the initial results of Iomab-ACT in Actinium's (ATNM) proof of concept data?

Initial proof of concept data for Iomab-ACT showed transient depletion of peripheral blood lymphocytes and monocytes, CAR-T cell persistence up to eight weeks post-infusion, and minimal non-hematologic toxicities, with no cases of immune effector cell-associated neurotoxicity syndrome (ICANS).