Actinium to Host KOL Webinar to Discuss Iomab-ACT Commercial CAR T-Cell Therapy Trial Design, Objectives and Potential Market Opportunity

Rhea-AI Summary

Actinium Pharmaceuticals will host a KOL webinar on May 20, 2024, at 8:00 AM ET to discuss the Iomab-ACT commercial CAR T-cell therapy trial being conducted at the University of Texas Southwestern (UTSW). Dr. Farrukh Awan, an expert in leukemia and lymphoma treatment, will join as the principal investigator. Iomab-ACT, an ARC targeting CD45, aims to replace non-targeted chemotherapy in conditioning prior to cell and gene therapies. Phase 1 trial results showed no immune effector cell-associated neurotoxicity syndrome (ICANS) in treated patients and minimal Cytokine Release Syndrome (CRS). The CAR-T market, projected to grow at an 11% CAGR, presents a significant opportunity for Iomab-ACT, which targets an addressable patient population expected to reach 93,000 in the U.S. by 2030.

Positive

• Webinar scheduled to discuss trial design and market opportunity for Iomab-ACT.
• Dr. Farrukh Awan, an expert in CAR-T therapy, will serve as principal investigator.
• Phase 1 trial results showed 0% ICANS and minimal CRS in patients treated with Iomab-ACT.
• Iomab-ACT aims to replace non-targeted chemotherapy, potentially improving patient outcomes.
• Market for CAR-T therapies is expected to grow at a CAGR of 11% over the next 5+ years.
• Addressable patient population for cell and gene therapies in the U.S. is expected to nearly double by 2030.

Negative

• No mention of definitive Phase 3 trial data or FDA approval status.
• data on long-term efficacy and overall survival rates for Iomab-ACT.
• Potential for high competition in the growing CAR-T and gene therapy markets.
• Uncertainties around the scalability and manufacturing capabilities for Iomab-ACT.

-  KOL and principal investigator, Dr. Farrukh Awan, Professor of Medicine, Division of Hematology Oncology at University of Texas Southwestern to join Actinium management on the webinar

-  Webinar to be held on Monday, May 20^th at 8:00 AM ET

NEW YORK, May 15, 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 webinar on Monday, May 20, 2024, at 8:00 AM ET. The call will highlight and discuss Actinium's recently announced Iomab-ACT commercial CAR T-cell trial being conducted at the University of Texas Southwestern (UTSW) including the study design, objectives and potential commercial opportunity for Iomab-ACT. 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-cell therapy. Dr. Farrukh Awan, Professor of Medicine, Division of Hematology Oncology at University of Texas Southwestern, 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 being led by UTSW.

Webinar Details and Registration:

Date: Monday, May 20^th, 2024

Time: 8 AM ET

Register here or on the investor relations page of Actinium's website here.

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.

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

When is Actinium's webinar on Iomab-ACT?

The webinar is scheduled for May 20, 2024, at 8:00 AM ET.

What is Iomab-ACT?

Iomab-ACT is an Antibody Radiation Conjugate (ARC) targeting CD45 for conditioning prior to cell and gene therapies like CAR T-cell therapy.

Who is the principal investigator for the Iomab-ACT trial?

Dr. Farrukh Awan, Professor of Medicine at the University of Texas Southwestern, will serve as the principal investigator.

What were the results of the Phase 1 trial for Iomab-ACT?

The Phase 1 trial showed 0% ICANS and minimal CRS in patients treated with Iomab-ACT.

How is the CAR-T market expected to grow?

The CAR-T market is projected to grow at a CAGR of 11% over the next 5+ years.

What is the potential market opportunity for Iomab-ACT?

The addressable market for Iomab-ACT includes an expected patient population of 93,000 in the U.S. by 2030.