Actinium Pharmaceuticals to Host Investor KOL Call with Dr. Ehab Atallah of the Medical College of Wisconsin and Provide a Pipeline Update Highlighting Revamped Clinical Programs and Expanded Market Opportunities for Actimab-A and Iomab-ACT with Clinical Data in 2H:2025

Rhea-AI Summary

Actinium Pharmaceuticals (NYSE: ATNM) announced plans to host a KOL call featuring Dr. Ehab Atallah to discuss their pipeline developments and market opportunities. The company highlighted three potential multi-billion-dollar markets for their targeted radiotherapies:

1. Actimab-A for myeloid malignancies including AML and MDS
2. Actimab-A combined with KEYTRUDA® and OPDIVO® for solid tumors
3. Iomab-ACT as a universal targeted conditioning agent for cell & gene therapies

Key upcoming milestones include:

• Clinical proof of concept data for Actimab-A combinations in solid tumors (2H:2025)
• Initial clinical data from Actimab-A triplet combination in frontline AML (year-end 2025)
• Planned pivotal Phase 2/3 trial for Actimab-A + CLAG-M in r/r AML
• Iomab-ACT commercial CAR-T trial initiation and data expected in 2H:2025

The company reports having cash runway extending into 2027.

Positive

• 18.4 month median overall survival achieved in Actimab-A + CLAG-M trial
• Cash runway extended into 2027
• Multiple clinical data readouts expected in 2H:2025
• Expansion into three potential multi-billion-dollar markets

Negative

• Clinical proof of concept data not available until late 2025
• Pivotal Phase 2/3 trial for Actimab-A + CLAG-M yet to commence

Insights

Biotechnology Analyst

Actinium Pharmaceuticals has announced a significant restructuring and expansion of its clinical pipeline, suggesting a strategic pivot to maximize the potential of its key radiotherapeutic assets. The company has identified three distinct multi-billion-dollar market opportunities for its lead candidates Actimab-A and Iomab-ACT spanning myeloid malignancies, solid tumors, and cell & gene therapy conditioning.

The pipeline expansion is particularly noteworthy for Actimab-A, which is now being positioned as a potential backbone therapy across multiple indications. The company has secured high-profile collaborations to test Actimab-A in combination with blockbuster immunotherapies KEYTRUDA® and OPDIVO® in solid tumors, representing a major expansion beyond hematological malignancies. Additionally, Actimab-A is advancing to frontline AML treatment in a triplet combination through an NCI collaboration.

The company's planned pivotal Phase 2/3 trial for Actimab-A + CLAG-M in relapsed/refractory AML is bolstered by impressive survival data - 18.4 months median overall survival published in Leukemia journal. This represents a significant improvement over standard treatments for this difficult-to-treat population.

For Iomab-ACT, Actinium is initiating trials in commercial CAR-T and sickle cell disease settings, positioning it as a universal conditioning agent to potentially improve outcomes and expand access to cell and gene therapies.

Financially, Actinium has confirmed a cash runway into 2027, providing substantial operational flexibility to advance these programs. With multiple data readouts expected in H2:2025, the company has established clear clinical milestones that could serve as potential value inflection points if positive.

Oncology Research Specialist

The expansion of Actinium's Actimab-A program represents a scientifically sound approach to leveraging targeted radiotherapy across multiple therapeutic contexts. The most compelling aspect is the mechanism-based expansion into solid tumors through MDSC depletion in combination with PD-1 inhibitors. This approach addresses a fundamental challenge in immunotherapy resistance by potentially eliminating immunosuppressive myeloid cells that limit checkpoint inhibitor efficacy.

The triplet combination of Actimab-A with Venetoclax and ASTX-727 in frontline AML strategically positions this therapy earlier in the treatment paradigm, where deeper remissions could potentially translate to more meaningful survival improvements. This approach aligns with current treatment evolution in AML, where combination therapies targeting multiple pathways have shown superior outcomes.

The published 18.4-month median overall survival for Actimab-A + CLAG-M in relapsed/refractory AML deserves particular attention. For context, patients with relapsed/refractory AML typically experience median survival of only 3-6 months with conventional salvage chemotherapy. While cross-trial comparisons require caution, this represents a potentially meaningful advancement if confirmed in a larger pivotal study.

For Iomab-ACT, the application in cell therapy conditioning addresses a critical unmet need. Current conditioning regimens using chemotherapy and radiation cause significant toxicity and limit patient eligibility. A targeted approach could potentially expand patient access while reducing treatment-related morbidity.

The multi-pronged clinical development strategy creates multiple shots on goal while leveraging a consistent therapeutic platform, increasing the probability of clinical and commercial success across at least one major indication.

-    Actinium to highlight 3 separate multi-billion-dollar market opportunities for Actimab-A and Iomab-ACT in myeloid malignancies, solid tumors and cell & gene therapy conditioning

-    Clinical proof of concept data expected in 2H:2025 from Actimab-A combination with blockbuster immunotherapies KEYTRUDA^® and OPDIVO^® in solid tumor indications

-    Actimab-A expanded into frontline AML in triplet combination with Venetoclax and ASTX-727, Taiho Oncology's hypomethylating agent, under NCI CRADA with initial clinical data expected by year-end 2025

-    Planned pivotal Phase 2/3 trial for Actimab-A + CLAG-M in relapsed/refractory AML patients further supported by recent publication of results in peer-reviewed journal Leukemia reporting 18.4 median overall survival

-    Iomab-ACT commercial CAR-T trial to initiate patient enrollment with clinical proof of concept data expected in 2H:2025; Iomab-ACT sickle cell disease trial expected to initiate in 1H:2025

-       Call Scheduled for 8:00 AM ET on Tuesday, March 25, 2025

NEW YORK, March 19, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today announced that it will host a KOL call that will feature Dr. Ehab Atallah, Professor of Medicine at the Medical College of Wisconsin and principal investigator of the Actimab-A + CLAG-M combination trial in patients with relapsed/refractory acute myeloid leukemia (r/r AML). Dr. Atallah will discuss Actimab-A clinical results to date including recently published long-term survival outcomes and the planned pivotal Phase 2/3 clinical trial in r/r AML and trials to be conducted under Actinium's cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). In addition, Actinium will provide a pipeline update to highlight 3 separate potential multi-billion-dollar blockbuster market opportunities for its targeted radiotherapies including the following:

• Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including AML and myelodysplastic syndromes (MDS) across multiple treatment settings
• Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)
• Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes

To register for the KOL Call & Pipeline Update please use the following link:

https://lifescievents.com/event/actinium-2/

Sandesh Seth, Actinium's Chairman and CEO, said, "We have made significant progress across our pipeline in the first quarter of 2025 achieving several important milestones. We are excited to highlight the large multi-billion-dollar market opportunities for Actimab-A in myeloid malignancies and now solid tumors, as well as cell and gene therapy conditioning with Iomab-ACT. With cash runway into 2027, we are in an excellent position to advance our programs, and we are excited to deliver validating data in the second half of 2025."

About Actinium Pharmaceuticals, Inc.

Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA^® and OPDIVO^® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for in the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 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 are the three market opportunities Actinium Pharmaceuticals (ATNM) is targeting with its radiotherapies?

ATNM is targeting myeloid malignancies with Actimab-A, solid tumors using Actimab-A in combination with immunotherapies, and cell & gene therapy conditioning with Iomab-ACT.

When will ATNM release clinical data for Actimab-A in solid tumor combinations?

Clinical proof of concept data for Actimab-A combinations with KEYTRUDA and OPDIVO in solid tumors is expected in second half of 2025.

What are the survival results from ATNM's Actimab-A + CLAG-M trial in relapsed/refractory AML?

The trial results published in the journal Leukemia reported an 18.4 month median overall survival for the Actimab-A + CLAG-M combination.

When will Actinium Pharmaceuticals (ATNM) initiate its Iomab-ACT sickle cell disease trial?

The Iomab-ACT sickle cell disease trial is expected to initiate in the first half of 2025.