Actinium Announces KOL Webinar to Highlight Recently Announced Iomab-ACT Trial with Leading FDA Approved Commercial CAR T-Cell Therapy Being Led by the University of Texas Southwestern

Rhea-AI Summary

Actinium Pharmaceuticals, Inc. announced a KOL webinar to discuss its Iomab-ACT trial with a leading FDA approved CAR T-cell therapy at the University of Texas Southwestern. The webinar will highlight the potential billion-dollar market opportunity in lymphodepletion. Dr. Farrukh Awan will lead the trial, aiming to study Iomab-ACT with an FDA approved CAR-T cell therapy for the first time. The company presented positive phase 1 trial results at the Tandem Meetings, showing promising safety and efficacy profiles. With the expanding CAR-T market and the need for improved conditioning in cellular therapy, Iomab-ACT presents a revenue opportunity in line with the growing patient population for cell and gene therapies.

Positive

• Positive phase 1 trial results with Iomab-ACT showed no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) and minimal Cytokine Release Syndrome (CRS), indicating promising safety and efficacy profiles.

• The webinar will discuss the potential billion-dollar market opportunity in lymphodepletion with the expansion of the Iomab-ACT program supported by ongoing MSKCC clinical trials.

• Dr. Farrukh Awan, a specialist in leukemia and lymphoma, will lead the trial to study Iomab-ACT with an FDA approved CAR-T cell therapy for the first time, aiming to improve conditioning prior to cell and gene therapies.

• With the rapidly expanding CAR-T and gene therapy pipeline, Iomab-ACT presents a revenue opportunity aligned with the expected growth in the patient population for cell and gene therapies, offering potential benefits in terms of lower CRS, less ICANS, and improved overall success rates in cellular therapy.

Negative

• None.

• Dr. Farrukh Awan, Professor of Medicine, Division of Hematology Oncology at University of Texas Southwestern and Principal Investigator for the trial to join Actinium management for webinar
• Expansion of Iomab-ACT program with commercial CAR-T supported by ongoing MSKCC clinical trial with success implying a potential billion-dollar market opportunity in lymphodepletion
• Webinar to be held on Monday, May 20^th at 8:00 AM ET

NEW YORK, May 7, 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 it will host a KOL call on Monday, 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.

Registration for the KOL webinar can be found here or on the investor relations page of Actinium's website here.

Iomab-ACT Phase 1 CAR-T Conditioning Results

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.

Targeted Radiotherapy Conditioning Opportunity

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. We will continue to develop Iomab-ACT, our next-generation conditioning program for rapidly growing cell and gene therapies based on early promising results, ultimately with the value proposition of improving overall access and outcomes for patients who need cellular or gene therapies. A potential blockbuster revenue opportunity exists for Iomab-ACT assuming it can provide one or more clinical benefits related to lower CRS, less ICANS, longer duration of response with selective lymphodepletion or a higher overall success rate of cellular therapy due to benefits of targeted conditioning.

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 (National Cancer Institute CRADA pivotal development path), 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 focus of Actinium's KOL webinar?

Actinium's KOL webinar will discuss the Iomab-ACT trial with a leading FDA approved CAR T-cell therapy at the University of Texas Southwestern, highlighting the potential billion-dollar market opportunity in lymphodepletion.

Who will lead the trial to study Iomab-ACT with an FDA approved CAR-T cell therapy?

Dr. Farrukh Awan, a specialist in leukemia and lymphoma, will lead the trial at the University of Texas Southwestern.

What were the results of Actinium's phase 1 trial using Iomab-ACT as conditioning prior to CD19 CAR-T therapy?

The phase 1 trial results showed no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) and minimal Cytokine Release Syndrome (CRS), demonstrating promising safety and efficacy profiles.

What revenue opportunity does Iomab-ACT present?

Iomab-ACT presents a revenue opportunity aligned with the growing patient population for cell and gene therapies, offering potential benefits such as lower CRS, less ICANS, and improved overall success rates in cellular therapy.