On May 16, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that an abstract pertaining to its lead product candidate, Iomab-B, which is being studied in the pivotal Phase 3 SIERRA study, will be presented via poster at the 2019 ASCO (Free ASCO Whitepaper) or American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that is being held from May 31st – June 4th at McCormick Place, in Chicago (Press release, Actinium Pharmaceuticals, MAY 16, 2019, View Source [SID1234536400]). The data to be presented at ASCO (Free ASCO Whitepaper) is a new analysis from the first 25% of patients enrolled in the SIERRA trial highlighting that by day 3 after Iomab-B administration, patients had a 98% median reduction in peripheral blasts and 100% reduction in blasts by day 8. This significant and rapid reduction in blasts occurred with patients receiving only a single therapeutic infusion of Iomab-B and no other pre-transplant conditioning. As a result, patients had significantly lower circulating leukemia burden prior to their BMT or Bone Marrow Transplant with all patients that received a therapeutic infusion of Iomab-B having robust engraftment despite active disease prior to Iomab-B conditioning.
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(PRNewsfoto/Actinium Pharmaceuticals, Inc.)
Details of the presentation are as follows:
Title: Rapid reduction of peripheral blasts in older patients with refractory acute myeloid leukemia (AML) using reinduction with single agent anti-CD45 targeted iodine (131I) apamistamab [Iomab-B] radioimmunotherapy in the phase III SIERRA trial
Presenter: Ben Kent Tomlinson, MD, Adult Hematologic and Stem Cell Transplant Section, Seidman Cancer Center, University Hospitals Case Medical Center (Cleveland, OH)
Date: Monday, June 3, 2019
Time: 8:00 AM – 11:00 AM Central Daylight Time
Location: Hall A, Poster Board #423, Abstract #7048
Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "We are pleased to have the opportunity to present additional information on our lead candidate Iomab-B at ASCO (Free ASCO Whitepaper). Iomab-B is an important therapeutic candidate and the SIERRA trial is the only Phase 3 trial to offer potentially curative BMT for older patients with active, relapsed or refractory acute myeloid leukemia. While Iomab-B has the potential to be a best-in-class bridge to transplant its profound anti-leukemic and re-induction capabilities must also be noted. Importantly, for the first time, this poster will demonstrate Iomab-B’s effect as a single agent to reduce patients’ circulating leukemia burden, which we find highly encouraging and link to the successful engraftment rates that have been observed in the SIERRA trial to date."
The abstract, which can be accessed on the ASCO (Free ASCO Whitepaper) iPlanner website (click here), presents data on 16 patients that had circulating peripheral blasts including 7 patients originally randomized to receive Iomab-B and 9 patients who crossed over from the control arm to receive Iomab-B after conventional care (salvage chemotherapy) failed to produce a complete remission. As reported in an oral presentation at ASH (Free ASH Whitepaper) 2018 (click here) and a late-breaking oral presentation TCT 2019 (click here), all patients receiving a therapeutic dose of Iomab-B in the SIERRA trial, either directly or via crossover, achieved successful engraftment without delay and donor chimerism by day 100 post-transplant without delay.
About Iomab-B
Iomab-B is an ARC or Antibody Radiation-Conjugate comprised of the anti-CD45 antibody apamistamab and the radioisotope iodine-131 that is intended to be a re-induction and conditioning agent prior to a BMT or bone marrow transplant. Iomab-B was developed at the Fred Hutchinson Cancer Research Center and has been studied in over 300 patients in multiple hematologic indications across 12 clinical trials in addition to the ongoing SIERRA study in older patients with active, relapsed or refractory AML or Acute Myeloid Leukemia prior to patients receiving an allogeneic BMT or bone marrow transplant. Iomab-B is Actinium’s lead targeting conditioning ARC in its multi-target, multi-indication targeted conditioning pipeline that includes the Iomab-B and Actimab-MDS programs for BMT and the Iomab-ACT program that will study a lower dose of Iomab-B for lymphodepletion prior to CAR-T and other cellular therapies.