On November 1, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that multiple abstracts highlighting its Antibody Radiation Conjugates (ARCs) have been accepted for presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, including an oral presentation of preliminary feasibility and safety results from its pivotal Phase 3 SIERRA trial of Iomab-B (Press release, Actinium Pharmaceuticals, NOV 1, 2018, View Source [SID1234530487]). The ASH (Free ASH Whitepaper) Annual Meeting is being held December 1 – 4, 2018 in San Diego, California. Data presented will highlight Actinium’s lead product candidate, Iomab-B, that is intended to be a targeted conditioning agent prior to a bone marrow transplant for patients with active relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55. Patients with active relapsed or refractory AML do not routinely undergo allogeneic bone marrow transplant due to a lack of efficacy using standard approaches and typically the survival of such patients without a transplant is less than six months.
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Iomab-B Oral Presentation Details
Abstract # 1017
Title: Targeted Conditioning of Iomab-B (131I-anti-CD45) Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Relapsed or Refractory Acute Myeloid Leukemia (AML): Preliminary Feasibility and Safety Results from the Prospective, Randomized Phase 3 Sierra Trial
Session Name: 721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Conditioning Intensity and Novel Approaches with Targeted therapy
Session Date: Monday, December 3, 2018
Presentation Time: 6:45 PM
Room: Manchester Grand Hyatt San Diego, Seaport Ballroom A
Presenter: Dr. Agura, Baylor University Medical Center
Results as of July 5, 2018
Dr. Mark Berger, Actinium’s Chief Medical Officer said, "We are honored that results from our ongoing Phase 3 trial have been accepted for an oral presentation at this year’s ASH (Free ASH Whitepaper) annual meeting as approximately just ten percent of accepted abstracts receive this designation. Most importantly, patients with active, relapsed or refractory AML have severely restricted access to bone marrow transplant, the only potentially curative treatment option, so we are we are elated that the initial feasibility and safety data from SIERRA has demonstrated the ability to enable transplant and engraftment for not only all patients initially randomized to Iomab-B but also all those that crossed-over from the control arm when salvage chemotherapy failed to produce a complete response. Importantly, this occurred in patients with high blast counts as the median blast count was 30% and 47% in the Iomab-B arm and cross-over patients, respectively. We look forward to having our data presented at ASH (Free ASH Whitepaper), providing additional updates on this important trial as it progresses and completing the SIERRA trial with the goal of bringing this important targeted conditioning agent to patients with a significant unmet need."
Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, "We are delighted that data representing an important cross-section of our Antibody Radiation Conjugate pipeline will be featured at this year’s ASH (Free ASH Whitepaper), particularly the presentation highlighting preliminary results from the SIERRA trial for our lead targeted conditioning asset, Iomab-B. Recognizing that a bone marrow transplant is a potentially curative treatment option for many hematologic diseases, Actinium is focused on improving bone marrow transplant access and outcomes through improved targeted conditioning, which is currently underserved by chemotherapy. We are excited that the data presented in the various forums at ASH (Free ASH Whitepaper) will demonstrate the capabilities of our highly differentiated ARC approach for targeted conditioning that we believe is unmatched by other technologies or approaches. We are committed to continuing to expand our targeted conditioning pipeline as we have done with Actimab-MDS with the goal of building an independent fully integrated company."
Data from the Company’s CD33 program ARC, Ac-225 – Lintuzumab, and the recently completed Actimab-A Phase 2 trial from for patients newly diagnosed with AML who are unfit for intensive chemotherapy has been accepted for poster presentation. Actinium recently announced in a CD33 program update that, based on the results of the Phase 2 Actimab-A trial, Actinium is continuing to develop Ac-225 – Lintuzumab in two combination trials for patients with relapsed or refractory AML, one being with Venetoclax and the other being with Venetoclax and Hypomethylating agents. Ac-225 – Lintuzumab is also being studied in patients with multiple myeloma and as a targeted conditioning agent to enable a bone marrow transplant for patients with high-risk Myelodysplastic Syndrome.
Actimab-A Abstract Details
Abstract # 1457
TITLE: A Phase 2 Study of Actinium-225 (225Ac)-Lintuzumab in Older Patients with Untreated Acute Myeloid Leukemia (AML) – Interim Analysis of 1.5 µci/Kg/Dose
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I
Date: Saturday, December 1, 2018
Presentation Time: 6:15 PM – 8:15 PM
Location: San Diego Convention Center, Hall GH
Actinium also submitted preliminary data from its Iomab-ACT program for next generation targeted lymphodepletion prior to CAR-T therapy. This data will be published online coinciding with the start of the 2018 ASH (Free ASH Whitepaper) Annual Meeting.