Actinium Highlights its Participation at the Upcoming Targeted Alpha Therapy International Symposium with Presentations on its AWE Platform, Clinical Programs and New Source of Ac-225 Isotope
- Two oral presentations, four poster presentations and panel participation will highlight Actinium's AWE technology platform, clinical programs, next-generation ARC's and the commercial renaissance of radiopharmaceuticals
- Poster to highlight feasibility studies using Actinium-225 produced by the U.S. Department of Energy in a high-energy linear proton accelerator
NEW YORK, March 26, 2019 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM), announced today that two oral and four poster presentations related to its Ac-225 or Actinium-225 based ARC's or Antibody Radiation-Conjugates have been accepted for presentation at the 11th Targeted-Alpha-Therapy International Symposium (TAT) being held April 1 – 4, 2019 in Ottawa, Canada. TAT is a bi-annual global conference which brings together thought leaders in alpha-particle therapy innovation. In addition to the oral and poster presentations, Actinium management will also participate in a panel entitled "The Renaissance of Radio Pharmaceuticals – A Commercial Perspective".
Ac-225 is a potent alpha-particle emitting isotope being utilized in Actinium's ARC programs for targeted conditioning in the planned pivotal Actimab-MDS trial as well as therapeutic and combination trials such as its Actimab-A Venetoclax combination trials and Actimab-MRD therapeutic trial. Ac-225 is also used in Actinium's AWE or Antibody Warhead Enabling Technology Platform to support its ongoing collaboration with Astellas Pharma, Inc. and to create next-generation ARC's. Exemplifying the potential of next-generation ARC's is the oral presentation highlighting Ac-225 labeled daratumumab (Darzalex®, Johnson & Johnson).
Dr. Dale Ludwig, Actinium's Chief Scientific Officer, said, "Actinium-225 is an isotope with great potential for therapeutic applications given its high energy, short pathlength and 10-day half-life. Due to its highly differentiated properties, we are increasing our research related to targeted Actinium-225 through our AWE platform to continue to drive highly differentiated programs to further expand our pipeline into areas of unmet need. We are excited to have the opportunity to highlight research spanning our clinical programs, novel next-generation ARC's and preclinical efforts with next generation Ac-225 at this year's TAT. As a leader in Actinium-225 based ARC's we are thrilled to be at the forefront of these efforts and are committed to continuing to advance this exciting field."
In addition to highlighting Actinium's clinical programs and AWE platform, Actinium will present a poster comparing the feasibility of using Ac-225 produced in a high-energy linear proton accelerator by the DOE or U.S. Department of Energy to that of traditional Ac-225 produced in a "thorium cow" or generator. The studies evaluated the feasibility of conjugating or labeling accelerator produced Ac-225 to lintuzumab, an anti-CD33 monoclonal antibody used in Actinium's CD33 ARC program, and the impact on ARC generation. The DOE's linear proton accelerator process is in addition to its existing generator-based processes and Actinium's proprietary process for manufacturing Ac-225 in a cyclotron, the last of which is covered by company patents, know-how and trade secrets.
Sandesh Seth, Actinium's Chairman and CEO, said, "We are excited to present data from our Ac-225 clinical programs and AWE platform at the preeminent conference focused on targeted alpha-particle therapies. We are committed to bringing important therapies to patients with high unmet needs and feel that Ac-225 has the potential to be an optimal warhead when applied in a targeted manner as we do. We intend to stay at the forefront of innovation with the Ac-225 isotope including ARC development, manufacturing and supply. We look forward to highlighting our capabilities and leadership position in several of these areas at TAT as evidenced by the breath and scope of our participation in several oral, poster and panel sessions."
Details of Actinium's presentations at TAT are as follows:
Title: Highly Effective Treatment of CD38 Positive Experimental Lymphoma with Actinium-225-Daratumuamb Sponsored by Actinium Pharmaceuticals, Inc. Date and Time:Tuesday, April 2, 201910:10 AM Presenter:Wojciech Dawicki, PhD, University of Saskatchewan Location: Ballroom, Fairmont Chateau Laurier
Title: Targeted Alpha-Particle Therapy for Hematologic Malignancies Date and Time:Thursday, April 4, 20192:00 PM Presenter:Joseph Jurcic, MD, Columbia University Medical Center Location: Ballroom, Fairmont Chateau Laurier
Title: Radiolabeling of DOTA-conjugated Lintuzumab with 225Ac: Comparison of Th-229-produced and High-Energy Proton Accelerator-produced 225Ac Date and Time:Tuesday, April 2, 2019 5:00 – 6:30 PM Location: Canadian Room, Fairmont Chateau Laurier Presenter:Dale Ludwig, PhD, Actinium Pharmaceuticals, Inc. Poster #54
Title: A Phase 2 Study of Actinium-225 (Ac-225-lintuzumab) in Older Patients with Untreated Acute Myeloid Leukemia (AML) Date and Time:Tuesday, April 2, 2019 5:00 – 6:30 PM Location: Canadian Room, Fairmont Chateau Laurier Presenter:Mark Berger, MD, Actinium Pharmaceuticals, Inc. Poster #61
Title: Dosimetric Impact of Ac-227 in Accelerator-Produced Ac-225 Date and Time:Tuesday, April 2, 2019 5:00 – 6:30 PM Location: Canadian Room, Fairmont Chateau Laurier Presenter:George Sgouros, PhD, Johns Hopkins University Poster #62
Title: Impact of Target Cell Number on Target Cell and Tissue Dose for Antibody-Mediated Delivery of Alpha-Emitters Date and Time:Tuesday, April 2, 2019 5:00 – 6:30 PM Location: Canadian Room, Fairmont Chateau Laurier Presenter:George Sgouros, PhD, Johns Hopkins University Poster #63
Title: The Renaissance of Radio Pharmaceuticals – A Commercial Perspective Date and Time:Tuesday, April 2, 2019 2:25 – 3:05 PM Location: Ballroom, Fairmont Chateau Laurier
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is focused on improving patient access and outcomes to cellular therapies such as BMT or Bone Marrow Transplant and CAR-T with its proprietary, chemotherapy free, targeted conditioning technology. Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning. Its targeted conditioning technology is enabled by ARC's or Antibody Radiation-Conjugates that combine the targeting ability of monoclonal antibodies with the cell killing ability of radioisotopes. Actinium's pipeline of clinical-stage targeted conditioning ARC's are designed to target the antigens CD45 and CD33 for patients with a broad range of hematologic malignancies including AML or Acute Myeloid Leukemia, MDS or Myelodysplastic Syndrome and MM or Multiple Myeloma.
Iomab-B, Actinium's lead targeted conditioning product candidate, is currently enrolling patients in the pivotal Phase 3 SIERRA trial in patients age 55 and older, with active, relapsed or refractory AML. Iomab-B (Iodine-131 apamistamab), combines the anti-CD45 monoclonal antibody labeled with iodine-131 for myeloablation prior to a bone marrow transplant. CD45 is expressed on leukemia, lymphoma and normal immune cells. Iomab-B has been studied in over 300 patients in 10 clinical trials in numerous hematologic diseases. Actinium's Iomab-ACT program is an expansion of its CD45 program that is intended to be a universal, chemotherapy-free solution for targeted lymphodepletion prior to CAR-T. Through targeted lymphodepletion, the Iomab-ACT program is expected to improve CAR-T cell expansion, reduce CAR-T related toxicities and expand patient access to CAR-T treatment and potentially other adoptive cell therapies. Due to its lower payload dose, lymphodepletion with the Iomab-ACT program may be accomplished through a single outpatient infusion. Actinium intends to advance its Iomab-ACT program with CAR-T focused collaborators from academia and industry.
Actinium's pipeline also includes a potentially best-in-class CD33 program with its ARC comprised of the anti-CD33 antibody lintuzumab labeled with the alpha-particle emitter actinium-225. Its CD33 program is currently being studied in multiple Phase 1 clinical trials for targeting conditioning, in combinations and as a therapeutic in multiple diseases and indications including AML, MDS and MM. Notable trials include the planned pivotal trial for Actimab-MDS for targeted conditioning prior to a BMT for patients with high-risk MDS, that is expected to initiate in 2019, and two Actimab-A venetoclax combination trials including the initiated Phase 1 doublet trial and the planned triplet trial with a hypomethylating agent.
Actinium is also developing its proprietary AWE or Antibody Warhead Enabling technology platform which utilizes radioisotopes including iodine-131 and the highly differentiated actinium-225 coupled with antibodies to target a variety of antigens that are expressed in hematological and solid tumor cancers. The AWE technology enables Actinium's internal pipeline and with the radioisotope actinium-225 is being utilized in a collaborative research partnership with Astellas Pharma, Inc. Actinium's clinical programs and AWE technology platform are covered by a portfolio of over 110 patents covering composition of matter, formulations, methods of use and also methods of manufacturing the radioisotope actinium-225 in a cyclotron.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release contains "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 performance of Actinium which Actinium 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, including without limitation its most recent annual report on Form 10-K for the period ended December 31, 2018, subsequent quarterly reports on Form 10-Q and current reports on Form 8-K, each as amended and supplemented from time to time.
Actinium Pharmaceuticals, Inc. Steve O'Loughlin Principal Financial Officer [email protected]