Actinium Highlights Mutation Agnostic Antileukemic Activity of Actimab-A Against FLT3, NPM1, KMT2A and TP53 Mutations in AML Models Demonstrating Backbone Potential for Acute Myeloid Leukemia Treatmen

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Apr 28, 2025
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  • Actimab-A shows significant antileukemic activity against multiple AML mutations.
  • Advancing multiple Phase 2/3 trials with promising combination therapies.
  • Large addressable market with over 100,000 potential patients in the U.S. and EU5.

Actinium Pharmaceuticals (ATNM, Financial) presented compelling data at the American Association for Cancer Research Annual Meeting, highlighting the preclinical efficacy of Actimab-A as a backbone therapy in acute myeloid leukemia (AML). The drug demonstrates mutation agnostic antileukemic effects against challenging AML mutations such as FLT3, NPM1, KMT2A, and TP53. The data showcase Actimab-A's ability to enhance tumor growth inhibition and prolong survival when combined with standard therapies like menin inhibitors, FLT3 inhibitors, and the hypomethylating agent azacitidine.

Actimab-A is the only CD33-targeted radiotherapy in development that uses the Actinium-225 isotope, targeting AML and other myeloid malignancies. The company is progressing with multiple clinical trials, with a pivotal Phase 2/3 trial combining Actimab-A with the chemotherapy regimen CLAG-M in patients with relapsed or refractory AML. Another study is underway involving Venetoclax and ASTX-727 in treatment-naïve AML under a cooperative research and development agreement with the National Cancer Institute.

The potential market for Actimab-A spans over 100,000 patients affected by AML and myeloid dysplastic syndromes (MDS) in the U.S. and EU5, representing a substantial commercial opportunity. Actinium Pharmaceuticals, with a market cap of approximately $38 million, anticipates generating clinical outcomes starting in the second half of this year to provide more definitive evidence of Actimab-A's efficacy and therapeutic value.

Disclosures

I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.