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Actinium Pharmaceuticals : Announces Several Presentations from the Phase 3 SIERRA Study of Iomab-B at the SNMMI 2021 Virtual Annual Meeting

06/04/2021 | 07:33am EDT

NEW YORK - Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ('Actinium' or the 'Company') announced that three abstracts highlighting data and findings from the Company's pivotal Phase 3 SIERRA trial for lead program Iomab-B, have been accepted for 2 oral and 2 poster presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2021 Annual Meeting, which is being held virtually June 11 - 14, 2021. Coinciding with SNMMI, Actinium will be hosting two Iomab-B advisory board meetings with nuclear medicine physicians, technicians, pharmacists, and physicists.

Dr. Mark Berger, Actinium's Chief Medical Officer, commented, 'We are pleased to highlight Iomab-B as well as data and findings from the pivotal Phase 3 SIERRA trial at SNMMI. Iomab-B represents a first-in-class radiotherapy for targeted conditioning given prior to a potentially curable BMT or bone marrow transplant for patients with active, relapsed or refractory acute myeloid leukemia age 55 and above. SIERRA is the only randomized Phase 3 trial to offer BMT as a treatment option to this patient population. These patients are not generally considered eligible for BMT with standard conditioning regimens, Iomab-B is also potentially best-in-class, as it has enabled all patients receiving a therapeutic dose to proceed to BMT and to engraft without delay. In addition, Iomab-B has been well tolerated with low rates of 100-day non-relapse transplant related mortality. With consistent results at 25%, 50% and 75% of target patient enrollment, we are excited to deliver results from full trial enrollment in the near future.'

Iomab-B SNMMI Presentations Details:

Oral Presentation Title:

Relationship of Marrow Radiation Dose and Timing of Engraftment for Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia

Session Date: 4:00 PM - 5:00 PM ET on June 14, 2021

Session Type: Oral - Physician Pharm

Session Title: Cancer Radiopharmaceutical Therapy

Presenter: Susan Passalaqua, MD, Banner MD Anderson Cancer Center

Poster Presentation Title: Low Incidence Rates of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia with Targeted Delivery of Anti-CD45 Iodine (131I) Apamistamab [Iomab-B

Publication Number: 1694

Session Title: Hematologic Malignancies

Presentation Time: 10:00:00 AM ET on June 14, 2021

Presenter: Neeta Pandit-Paskar, MD, Memorial Sloan Kettering Cancer Center

Oral Presentation Title: Feasibility of Machine Learning-Assisted Personalized Dosimetry for Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia; a Phase III Clinical trial

Session Date: 11:30 AM - 12:30 PM ET on June 14, 2021

Session Type: Oral - Physician Pharm

Session Title: New Tools for Optimizing Theranostic Implementation

Presenter: Roberto Fedrigo, BC Cancer Research Institute and the University of British Columbia

Poster Presentation Title: Feasibility of Machine Learning-Assisted Personalized Dosimetry for Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia; a Phase III Clinical trial

Publication Number: 73

Session Title: New Tools for Optimizing Theranostic Implementation

Presentation Time: 11:30:00 AM - 12:30:00 PM ET on June 14, 2021

Sandesh Seth, Actinium's Chairman and CEO commented, 'We are honored that multiple abstracts featuring the SIERRA trial have been selected for presentation to thought leaders from around the globe at SNMMI. The nuclear medicine community is a key Iomab-B stakeholder and through its support and commitment, we have advanced to the final stages of the pivotal Phase 3 SIERRA trial. As we approach completion of the SIERRA trial, we are also excited to have the opportunity to engage with key thought leaders across multiple nuclear medicine disciplines and utilize their guidance to ensure Iomab-B's future success. With the progress we are making, we are closer to realizing our vision of enabling better BMT outcomes and access with Iomab-B and will continue to advance towards achieving the same vision for adoptive cell and gene therapies.'


The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to advancing nuclear medicine and molecular imaging-precision medicine that allows diagnosis and treatment to be tailored to individual patients in order to achieve the best possible outcomes. For more information, visit www.snmmi.org.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. Iomab-ACT (low dose I-131 apamistamab) is also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center and is intended to be studied for conditioning prior to gene therapy. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 140 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

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.


Hans Vitzthum

LifeSci Advisors, LLC

E: Hans@LifeSciAdvisors.com

T: (617) 430-9758

(C) 2021 Electronic News Publishing, source ENP Newswire

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Financials (USD)
Sales 2021 1,02 M - -
Net income 2021 -22,3 M - -
Net Debt 2021 - - -
P/E ratio 2021 -7,64x
Yield 2021 -
Capitalization 182 M 182 M -
Capi. / Sales 2021 179x
Capi. / Sales 2022 11,8x
Nbr of Employees 32
Free-Float 98,6%
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Sandesh Seth Chairman & Chief Executive Officer
Steve O'Loughlin Chief Financial Officer
Dale L. Ludwig Chief Scientific & Technology Officer
Avinash Desai Chief Medical Officer
Mary Mei Chen Vice President-Clinical Development
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