Actinium to Highlight Broad Potential of Targeted Radiotherapies Iomab-B and Actimab-A for Relapsed or Refractory and Elderly Acute Myeloid Leukemia Patients at the 65th ASH Annual Meeting & Exposition

Rhea-AI Summary

Actinium Pharmaceuticals, Inc. (ATNM) announces that clinical data from its Iomab-B and Actimab-A programs will be featured in four presentations at the 65th Annual ASH Meeting, highlighting the differentiated capabilities of Iomab-B and Actimab-A in improving overall survival in patients with relapsed or refractory AML with a TP53 mutation.

Positive

• Clinical data from Iomab-B and Actimab-A programs will be featured in four presentations at the 65th Annual ASH Meeting.
• Iomab-B and Actimab-A have demonstrated the ability to overcome genetic mutations, including TP53, producing high response rates and improving survival outcomes in patients with difficult to treat, high-risk r/r AML.

Negative

• None.

• Oral presentation to highlight Iomab-B's ability to significantly improve overall survival in patients with relapsed or refractory AML with a TP53 mutation
• Four presentations in total demonstrating the mutation agnostic efficacy potential of Iomab-B and Actimab-A in relapsed or refractory and elderly AML patients

NEW YORK, Dec. 8, 2023 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced that clinical data from its Iomab-B and Actimab-A programs will be featured in four presentations at the 65^th Annual American Society of Hematology Annual Meeting & Exposition (ASH) being held in San Diego on December 9-12, 2023. These include an oral presentation and two poster presentations detailing results from the completed and positive Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) as well as one poster presentation of Phase 1b results from the novel Actimab-A + Venetoclax combination trial for r/r AML.

Sandesh Seth, Actinium's Chairman & CEO, said, "We are particularly excited for this year's ASH as our four presentations will highlight the differentiated capabilities of Iomab-B and Actimab-A. Better treatment options and outcomes are needed in AML, particularly for elderly patients and those with relapsed or refractory disease who represent a majority of the population. Our strong presence at ASH is indicative of the potential that our targeted radiotherapies have in the management of patients with difficult to treat AML. We are progressing toward BLA and MAA filings for Iomab-B as well as initiating a pivotal trial Actimab-A next year, which will be significant steps toward achieving our vision of transforming the treatment of AML with our highly differentiated therapies."

Iomab-B and Actimab-A target CD45 and CD33, respectively, both of which are validated targets with significant expression on AML cells. As targeted radiotherapeutics, Iomab-B and Actimab-A have both demonstrated the ability to overcome genetic mutations, including TP53, producing high response rates and improving survival outcomes in patients with difficult to treat, high-risk r/r AML.

Details of Actinium's presentations at ASH are as follows:

Iomab-B Oral Presentation

Title: ¹³¹I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML

Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Novel Conditioning Regimens for Myeloid Malignancies
Session Date: Sunday, December 10, 2023
Session Time: 9:30 AM - 11:00 AM Pacific Time
Presentation Time: 9:30 AM
Room: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 18-19

Iomab-B Poster Presentations

Title: ¹³¹I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors

Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster I
Session Date: Saturday, December 9, 2023
Presentation Time: 5:30 PM - 7:30 PM Pacific Time
Location: San Diego Convention Center, Halls G-H

Title: High-Dose Targeted Radiation with ¹³¹I-Apamistamab Prior to HCT Demonstrated a Dose-Response for Durable Complete Remission in Patients with R/R AML

Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster II
Session Date: Sunday, December 10, 2023
Presentation Time: 6:00 PM - 8:00 PM Pacific Time
Location: San Diego Convention Center, Halls G-H

Actimab-A Poster Presentation

Title: Updated Results from Phase 1 Study of Targeted Radiotherapy with Lintuzumab-Ac225 in Combination with Venetoclax in Relapsed/Refractory AML

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I
Session Date: Saturday, December 9, 2023:
Presentation Time: 5:30 PM-7:30 PM
Location: San Diego Convention Center, Halls G-H

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), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic, 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's technology platform is the basis for collaborations with Astellas Pharma for solid tumors, AVEO Oncology/LG Chem Life Sciences for HER3 solid tumors, and several internal programs in solid tumors. Actinium holds more than 220 patents and patent applications.

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 significance of the clinical data from Iomab-B and Actimab-A programs being featured in four presentations at the 65th Annual ASH Meeting?

The clinical data being featured in four presentations at the 65th Annual ASH Meeting highlights the differentiated capabilities of Iomab-B and Actimab-A in improving overall survival in patients with relapsed or refractory AML with a TP53 mutation.

What are the validated targets for Iomab-B and Actimab-A?

Iomab-B and Actimab-A target CD45 and CD33, respectively, both of which are validated targets with significant expression on AML cells.

What are the details of the Iomab-B oral presentation at the ASH Meeting?

The Iomab-B oral presentation is titled '131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML' and will be held on December 10, 2023, at 9:30 AM Pacific Time.

What are the details of the Iomab-B poster presentations at the ASH Meeting?

There are two Iomab-B poster presentations, one on '131I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors' and another on 'High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT Demonstrated a Dose-Response for Durable Complete Remission in Patients with R/R AML'.

What are the details of the Actimab-A poster presentation at the ASH Meeting?

The Actimab-A poster presentation is titled 'Updated Results from Phase 1 Study of Targeted Radiotherapy with Lintuzumab-Ac225 in Combination with Venetoclax in Relapsed/Refractory AML' and will be held on December 9, 2023, at 5:30 PM Pacific Time.