Tuesday, November 14, 2017 8:26:38 AM
- AWE Program launched post successful demonstration of Actinium’s “Biobetter” capabilities as evidenced by superior experimental results with actinium-225 labeled daratumumab when compared to unlabeled daratumumab, a blockbuster antibody therapy targeting CD38 in patients with multiple myeloma
- AWE Program will leverage Actinium’s intellectual property, know-how and expertise around its Actinium Warhead Enabling (AWE) Technology Platform
Recently, Actinium announced that it successfully labeled the anti-CD38 monoclonal antibody daratumumab, a blockbuster therapy for patients with multiple myeloma, with actinium-225. Stability and target engagement was similar between the unlabeled and actinium-225 labeled antibody, demonstrating that the Company’s AWE Technology can successfully label a CD38 targeting agent without disrupting binding. In-vitro experiments with both the labeled and unlabeled antibody were performed in the same cell lines that initially established daratumumab’s proof of concept. In each CD-38 expressing cell line, improved cell killing was observed with the actinium-225 enabled daratumumab. The previous maximum reported cell killing was 62% with the naked daratumumab. However, at 1/10 of that antibody concentration the cell killing was 97% with the actinium-225 enabled daratumumab. Additionally, the cell-killing effect demonstrated both a time and concentration dependency. Importantly, specificity is demonstrated as no cell killing was observed when a cell line that does not express the target CD38 was treated with the actinium-225 labeled daratumumab. Data from this study were accepted as an abstract for poster presentation at the upcoming 59th American Society of Hematology (ASH) Meeting Annual which can be viewed in the following link: https://ash.confex.com/ash/2017/webprogram/Paper105329.html.
Sandesh Seth, Actinium’s Chairman and CEO said, “The element actinium-225 is tremendously potent yet highly specific given its short path length, making it the ideal warhead for oncology indications when labeled to monoclonal antibodies. Through the development of our drug candidates, we have gained significant expertise and know-how in the application of actinium-225 and we look forward to providing our proprietary technology and highly specialized know how and supply chain capabilities to potential partners via our AWE Program. This expertise is evidenced by the recent results showing that actinium-225 increased the cell killing power of the blockbuster multiple myeloma antibody therapy daratumumab at 10-fold lower antibody concentration in Daudi cells. We are currently utilizing our technology toward generating potential “Biobetters” of selected commercial targeting agents and believe that our technology can be applied to a significant number of antibodies, peptides, Fab fragments or other targeting moieties. We look forward to working in collaboration via the AWE Program with biopharmaceutical companies that would like to increase the efficacy of their commercial or development stage antibodies to improve patient outcomes and also to better manage the lifecycle of their commercial antibodies.”
About Our Actinium Warhead Enabling Technology Platform
The Actinium Warhead Enabling (AWE) Technology Platform enables a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with targeting agents, which are designed to seek out cancer cells in the body that express particular markers. Actinium-225 emits significant alpha radiation making it a potent treatment modality against targeted cancer cells while limiting damage to healthy tissues as its radiation travels extremely short distances in the body. When labeled to targeting agents, actinium-225 can be delivered directly to cancer cells where the high linear energy transfer resulting from the emission of alpha particles results in irreparable DNA double stranded breaks and ultimately cancer cell death. Despite this superior cell killing power, actinium-225 when delivered in a targeted manner is sparing of the surrounding environment in the body due to the short path length of its alpha-particle radiation and can result in a superior safety profile. Actinium Pharmaceuticals owns or has licensed the rights to several issued and pending patents that pertain to its AWE Technology Platform including technology to manufacture actinium-225 in a cyclotron. In addition, the Company obtains actinium-225 from various sources such as the U.S. Department of Energy at Oak Ridge National Laboratories and has developed considerable know-how, expertise and validated processes related to production of radioimmunoconjugates, management of the supply chain and dealing with various regulatory bodies. The AWE Technology Platform can be utilized to potentially improve the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. via labeling with actinium-225. In addition to increased efficacy, these actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents provide an opportunity to extend intellectual property protection by the creation of “Biobetters” or improved versions of the approved agent. The Company’s Actinium Warhead Enabling (AWE) Program can be accessed by biopharmaceutical companies that are interested in creating Biobetters through the utilization of the AWE Platform Technology. To learn more about the AWE Technology Platform or the AWE Program please contact Keisha Thomas, Ph.D., Corporate Development at mailto://kthomas@actiniumpharma.com.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. We are currently conducting clinical trials for our three product candidates, Iomab-B, Actimab-A and Actimab-M, as well as performing research on other potential drug candidates utilizing our proprietary actinium-225 technology platform. Our most advanced product candidate, Iomab-B, is comprised of an anti-CD45 monoclonal antibody labeled with iodine-131. We are currently conducting a pivotal Phase 3 trial of Iomab-B for myeloablation and conditioning of the bone marrow prior to a bone marrow transplant for patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow transplant is a potentially curative treatment option for patients with AML and other blood cancers including leukemias, lymphomas and multiple myeloma as well as certain blood disorders. Upon successful completion of our Phase 3 clinical trial for Iomab-B we intend to submit this candidate for marketing approval in the U.S. and European Union. Our most advanced alpha-particle based therapy, Actimab-A, is an anti-CD33 monoclonal antibody conjugated with the alpha-particle actinium-225 (Ac-225). Actimab-A is currently in a Phase 2 clinical trial for patients over the age of 60 who are newly diagnosed with AML and ineligible for standard induction chemotherapy. Actimab-M, our third product candidate, is the same anti-CD33 monoclonal antibody conjugated to Ac-225 administered at a different dose and dosing regimen. Actimab-M, is being studied in a Phase 1 trial for patients with refractory multiple myeloma. We expect our AWE Technology Platform will generate additional drug candidates that we will progress in clinical trials ourselves and or out-license. More information available at http://www.actiniumpharma.com and Twitter feed @ActiniumPharma, http://www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This news release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contact:
Actinium Pharmaceuticals, Inc.
Steve O'Loughlin
Principal Financial Officer
mailto://soloughlin@actiniumpharma.com
Investor Relations
Marek Ciszewski, J.D.
949.574.3860
mailto://ATNM@liolios.com
Recent ATNM News
- Actinium Pharmaceuticals Announces Publication of Results from the Phase 3 SIERRA Trial of Iomab-B in the Journal of Clinical Oncology • PR Newswire (US) • 09/20/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/05/2024 09:15:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/05/2024 11:30:34 AM
- Actinium Provides Regulatory Update on Planned BLA Filing and Future Plans for Iomab-B in the U.S. • PR Newswire (US) • 08/05/2024 11:00:00 AM
- Actinium Expands Patent Coverage Over Iomab-ACT, its Next-Generation Targeted Radiotherapy Conditioning Agent, for Gene Edited Stem Cell-Based Therapies for Non-Malignant Indications • PR Newswire (US) • 08/01/2024 12:00:00 PM
- Actinium Announces FDA Clearance of Iomab-ACT Targeted Conditioning IND Application for Sickle Cell Disease Patients Undergoing Bone Marrow Transplant in Collaboration with Columbia University • PR Newswire (US) • 07/25/2024 12:45:00 PM
- Actinium Pharmaceuticals to Present at the 3rd Annual Targeted Radiopharmaceuticals Summit US • PR Newswire (US) • 07/25/2024 11:30:00 AM
- Actinium Presents First Ever Data Demonstrating Actimab-A in Combination with Leading Menin Inhibitors Leads to Anti-Tumor Control and Potent Leukemic Cell Killing in Preclinical Acute Myeloid Leukemia Models at the 2024 EHA Congress • PR Newswire (US) • 06/17/2024 12:00:00 PM
- Actinium Highlights Oral Presentation at EHA 2024 Annual Congress Featuring Improved Outcomes in TP53 Positive Patients Receiving Iomab-B in the Phase 3 SIERRA Trial • PR Newswire (US) • 06/14/2024 12:30:00 PM
- Actinium Announces Results of Actimab-A + CLAG-M Combination Trial Highlighted in Oral Presentation at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting • PR Newswire (US) • 06/11/2024 12:30:00 PM
- Actinium Highlights Mutation Data from the Phase 3 SIERRA Trial of Iomab-B and Novel Linker Technology to Support Solid Tumor Antibody Radiation Conjugate Development at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting • PR Newswire (US) • 06/10/2024 12:30:00 PM
- Actinium to Host KOL Webinar to Discuss Iomab-ACT Commercial CAR T-Cell Therapy Trial Design, Objectives and Potential Market Opportunity • PR Newswire (US) • 05/15/2024 12:30:00 PM
- Actinium Announces Oral Presentation Detailing Improved Survival Outcomes in TP53 Positive Patients at the EHA 2024 Annual Congress and Presentation of Long-Term Efficacy Results in Older Patients Receiving an Iomab-B Led Bone Marrow Transplant in the Phas • PR Newswire (US) • 05/14/2024 10:38:00 PM
- Actinium Announces Multiple Abstracts Highlighting its Antibody Radiation Conjugates Iomab-B and Actimab-A and Novel Linker Technology for Solid Tumors Accepted for Presentation at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting • PR Newswire (US) • 05/13/2024 12:30:00 PM
- Actinium Announces KOL Webinar to Highlight Recently Announced Iomab-ACT Trial with Leading FDA Approved Commercial CAR T-Cell Therapy Being Led by the University of Texas Southwestern • PR Newswire (US) • 05/07/2024 12:00:00 PM
- Actinium Highlights Ability of Iomab-B to Overcome High-Risk TP53 Mutation Resulting in Significant Improvement in Overall Survival in Patients with Active Relapsed Refractory AML at the European Bone Marrow Transplant Annual Meeting • PR Newswire (US) • 04/18/2024 12:00:00 PM
- Actinium Announces Iomab-B Phase 3 SIERRA Trial Results Demonstrating Survival Benefit in High-Risk Relapsed or Refractory Acute Myeloid Leukemia Patients with TP53 Mutations Accepted for Oral Presentation at the 50th European Bone Marrow Transplant Annual • PR Newswire (US) • 04/01/2024 12:00:00 PM
- Actinium Announces Clinical Trial to Study Iomab-ACT Targeted Radiotherapy Conditioning with Leading FDA Approved Commercial CAR T-Cell Therapy • PR Newswire (US) • 03/26/2024 11:18:00 AM
- Actinium Pharmaceuticals Launches Actinium-225 Focused Strategic Initiative to Leverage Proprietary Cyclotron Based Manufacturing Technology to Address Growing Market Demand • PR Newswire (US) • 03/11/2024 11:30:00 AM
- Actinium Announces Iomab-B Markedly Increases Long Term Survival in Patients 65 Years or Older with Active Relapsed or Refractory AML in the Phase 3 SIERRA Trial at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMT • PR Newswire (US) • 02/26/2024 12:30:00 PM
- Actinium Highlights Improved Survival with Iomab-B in TP53 Positive Relapsed Refractory Acute Myeloid Leukemia Patients in the SIERRA Trial and Other Presentations at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIB • PR Newswire (US) • 02/23/2024 12:30:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/09/2024 09:30:19 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/06/2024 05:15:04 AM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/02/2024 10:03:47 PM
- Actinium Announces Acceptance of Five Abstracts for Presentation at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR® • PR Newswire (US) • 01/02/2024 12:30:00 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM