Actinium Announces Clinical Trial to Study Iomab-ACT Targeted Radiotherapy Conditioning with Leading FDA Approved Commercial CAR T-Cell Therapy

Rhea-AI Summary

Actinium Pharmaceuticals, Inc. announces a potential breakthrough in targeted radiotherapy conditioning with Iomab-ACT, aiming to replace non-targeted chemotherapy in cell and gene therapies. The collaboration with UT Southwestern for a clinical trial on CAR T-cell therapy shows promising results in reducing toxicities like ICANS and CRS. Iomab-ACT presents a significant market opportunity in the growing field of cellular and gene therapies.

Oncology Doctor

The introduction of Iomab-ACT as a targeted radiotherapy conditioning agent represents a significant advance in the field of hematologic oncology. The ability to condition patients more selectively before CAR T-cell therapy has the potential to not only reduce the incidence of serious side effects such as ICANS and CRS but also may improve the efficacy of CAR T-cell therapy itself. This is particularly pertinent given the high morbidity associated with these toxicities and the fact that they can be a limiting factor in the applicability of CAR T-cell treatments.

From a clinical perspective, the use of targeted radiotherapy could represent a paradigm shift in patient preparation for cell and gene therapies, which could lead to broader adoption of these treatments. The implications for patient outcomes, including the possibility of improved survival rates and quality of life, are substantial. It is also worth noting that the ability to deplete targeted immune cells while preserving CAR T-cell persistence could lead to more durable remissions in hematologic malignancies.

Medical Research Analyst

Assessing the potential market impact of Iomab-ACT requires an understanding of the current limitations of CAR T-cell therapy. The current standard of using chemotherapy for conditioning is suboptimal due to non-specificity and associated toxicities. The development of a targeted radiotherapy agent like Iomab-ACT could address these issues, potentially expanding the eligible patient population for CAR T-cell therapy. This expansion is particularly relevant in light of the forecasted growth in the cell and gene therapy patient population.

Furthermore, the financial implications of reducing CAR-T therapy-related toxicities cannot be overstated. By potentially lowering healthcare costs associated with the management of ICANS and CRS, Iomab-ACT could present a compelling value proposition to healthcare providers and payers. Additionally, if Iomab-ACT leads to improved patient outcomes, this could translate into a competitive advantage in a market with a growing number of CAR T-cell therapies.

Market Research Analyst

From a market perspective, the introduction of Iomab-ACT by Actinium Pharmaceuticals into the CAR T-cell therapy landscape is poised to capture a significant share of a burgeoning market, given the projected patient population growth. The early clinical data suggesting reduced toxicities and improved patient access could position Iomab-ACT as a preferred conditioning regimen, potentially displacing the current chemotherapy standards.

With the CAR T-cell therapy market already exceeding $3.5 billion in sales and expected to grow at a CAGR of approximately 11%, the financial implications for Actinium could be substantial if Iomab-ACT delivers on its clinical promises. It is important to monitor the upcoming clinical trial results led by UT Southwestern, as they will be critical in determining the commercial viability and potential market penetration of Iomab-ACT. Successful trial outcomes could attract partnerships and possibly lead to an increase in stock market valuation for Actinium Pharmaceuticals.

• Potential blockbuster opportunity for next-generation targeted radiotherapy conditioning with CAR T-cell therapy a multi-billion market with six FDA approved therapies totaling sales over $3.5 billion in 2023 and cell and gene therapies forecasted to reach over ninety-thousand patients annually by 2030
• Iomab-ACT is the first targeted radiotherapy agent intended to be used to condition patients for cell and gene therapies to replace the need for non-targeted chemotherapy
• Iomab-ACT clinical data to date shows CAR T-cell persistence and ability to deplete targeted immune cells including lymphocytes resulting in negligible rates of CAR-T toxicities ICANS and CRS

NEW YORK, March 26, 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 that the University of Texas Southwestern Medical Center (UT Southwestern) will lead a clinical trial studying Actinium's Iomab-ACT, a targeted radiotherapy conditioning agent prior to patients receiving an FDA approved commercial CAR T-cell therapy. UT Southwestern will start recruiting patients following FDA's review and clearance of the study. CAR T-cell therapy utilizes patients' own immune cells called T-cells, which are engineered to include a chimeric antigen receptor and then reinfused into the patient to recognize and destroy cancer cells. Currently, there are six CAR-T therapies approved to treat patients with leukemias, lymphomas and multiple myeloma that collectively reached sales in 2023 exceeding $3.5 billion.

Actinium developed Iomab-ACT with the goal of replacing the chemotherapy conditioning regimens currently used prior to cell and gene therapies. Early clinical data with Iomab-ACT conditioning prior to CAR-T demonstrates its ability to produce targeted lymphodepletion along with negligible incidences of immune effector cell-associated neurotoxicity syndrome (ICANS) or cytokine release syndrome (CRS), which are the major toxicities observed with the current chemotherapy based conditioning regimens, which are suboptimal and can limit patients from CAR-T access and may result in poor outcomes. 

Sandesh Seth, Actinium's Chairman and CEO, stated, "This is a pivotal moment for our Iomab-ACT program that presents the opportunity to produce potential practice changing clinical data. Cellular therapies such as CAR-T and gene therapies represent a multi-billion market opportunity with an expectation of nearly doubling to reach approximately 93,000 patients annually in the U.S. alone by 2030. We believe Iomab-ACT can be a universal conditioning regimen based on its potential to reduce CAR-T related toxicities such as ICANS and CRS, as evidenced by our early clinical work with a novel CD19 CAR T-cell therapy and may improve patient access and outcomes by eliminating the need for the non-targeted chemotherapy-based conditioning that are currently required prior to CAR-T therapies. This trial is a clear demonstration of Actinium's commitment to being at the forefront of applying targeted radiotherapy to innovative applications and novel indications."

Dr. Avinash Desai, Actinium's Chief Medical Officer, added, "Cellular therapies like CAR-T have transformed outcomes for tens of thousands of patients but clinicians continue to be frustrated with the need to use chemotherapy for conditioning. We are excited to be collaborating with the team at UT Southwestern on this first ever trial to study Iomab-ACT with a commercial CAR-T. Given the extensive data with CAR-T therapies_{, ­}results from this study can allow us to show the impact of Iomab-ACT on reducing CAR-T related toxicities such as ICANS and CRS and improving efficacy including persistence of CAR-T cells, rates of response, and other efficacy outcomes. Based on the initial results from our clinical trial with Memorial Sloan Kettering's CD19 CAR-T therapy, we are looking forward to initiating this study and delivering clinical proof of concept data with a commercial CAR-T."

Ongoing 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, as ICANS is observed in 25% or more of pts w/ R/R B-ALL and DLBCL treated with various CAR T-cell products and minimal CRS. 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 receive conditioning of some type 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 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 220 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:
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SOURCE Actinium Pharmaceuticals, Inc.

What is the significance of Iomab-ACT in the field of targeted radiotherapy conditioning for cell and gene therapies?

Iomab-ACT aims to replace non-targeted chemotherapy in conditioning patients for cell and gene therapies, potentially reducing toxicities and improving outcomes.

What are the key findings from the ongoing Phase 1 trial using Iomab-ACT as conditioning prior to CD19 CAR-T therapy?

Results show no patients developed ICANS, with transient lymphocyte and monocyte depletion, CAR T-cell persistence up to 8 weeks, and minimal non-hematologic toxicities.

What is the market potential for Iomab-ACT in the context of the growing cellular and gene therapy market?

Iomab-ACT targets a market of approximately 93,000 patients in the U.S. by 2030, with a potential blockbuster revenue opportunity by offering clinical benefits in targeted conditioning.