On April 19, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies for patients with unmet needs reported that highlighted its activity at the upcoming Transplantation & Cellular Therapy (TCT) Tandem Meetings of ASTCT and CIBMTR, the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) being held April 23 – 26, 2022 virtually and in Salt Lake City, Utah (Press release, Actinium Pharmaceuticals, APR 19, 2022, View Source [SID1234612502]).
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Updated data from the fully enrolled pivotal Phase 3 SIERRA trial (Study of Iomab-B versus Conventional Care in Elderly, Relapsed or Refractory Acute Myeloid Leukemia) will be highlighted in an oral presentation by Boglarka Gyurkocza, M.D., investigator from Memorial Sloan Kettering Cancer Center, which was the highest enrolling trial site in the SIERRA trial. In addition, Actinium will be conducting medical affairs activity at TCT by engaging with the bone marrow transplant (BMT) community including featuring Iomab-B in a continuing medical education (CME) symposium titled "Landmarks Across the Patient Journey in AML, Applying Evidence with Novel Therapeutics Pre- and Post-AlloHCT" that will be led by Dr. Naval Daver, from The University of Texas MD Anderson Cancer Center and Dr. James Foran from the Mayo Clinical Cancer Center in Jacksonville, Florida.
Dr. Avinash Desai, Actinium’s Chief Medical Officer, stated, "We are excited to attend the TCT Tandem Meetings and once again feature Iomab-B and the SIERRA trial at this preeminent bone marrow transplant and cell therapy conference. Iomab-B has the potential to lead a paradigm shift in targeted conditioning aimed at increasing access to potentially curative treatments like BMT and improving patient outcomes with its differentiated targeted radiotherapy mechanism. Data from the SIERRA trial has shown a consistent 100% rate of BMT access and engraftment in all patients receiving Iomab-B compared to only 17% of patients in the control arm who received multiple therapies including recently approved targeted therapies such as Venetoclax, FLT-3 and IDH inhibitors. In addition, patients receiving Iomab-B have had lower rates on non-relapse transplanted related mortality 100-days post-transplant and lower rates of adverse events including statistically significant lower rates of sepsis and lower rates of febrile neutropenia, which we believe is attributed to the targeted nature of Iomab-B. With topline data from SIERRA expected in the third quarter of this year, we look forward to SIERRA data being featured in an oral presentation and highlighting it in the numerous interactions we have planned with BMT physicians, scientists and care givers at TCT."
Iomab-B TCT Presentation Details:
Presentation Title: High Rates of Transplantation in the Phase III SIERRA Trial Utilizing Anti-CD45 (Iodine) 131-I-Apamistmab (Iomab-B) Conditioning with Successful Engraftment and Tolerability in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) Patients after Lack of Response to Conventional Care and Targeted Therapies
Date and Time: Saturday, April 23, 2022, 6:30 PM ET
Location: Salt Palace Convention Center – Ballroom I
Sandesh Seth, Actinium’s Chairman and CEO, added, "TCT is always a highly impactful conference for Actinium as we get to showcase Iomab-B to the largest gathering of transplant physicians. This year is particularly exciting as we will highlight the strong data from 100% patient enrollment showing a 5-times greater number of Iomab-B patients potentially evaluable for the primary endpoint than control arm in the SIERRA trial at 100-days post BMT. With topline data in sight, this is a great time to be engaging the BMT community. Assuming success with Iomab-B, we see an opportunity to be the leading developer of targeted conditioning regimens based on our Iomab-B and Iomab-ACT radiotherapies that can make BMT, CAR-T and other adoptive cell therapies as well as gene therapies more accessible and bring potential cures closer in reach for patients with high unmet needs."
About the Tandem Meetings
The Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Administrators, clinicians, data manager / clinical research professionals, fellows-in-training, investigators, laboratory technicians, MD/PhDs, nurses, nurse practitioners, pharmacists, physician assistants, and other allied health professional attendees benefit from a full scientific program that addresses the most timely issues in hematopoietic cell transplantation and cellular therapy.
About Iomab-B
Iomab-B (I-131 apamistamab), via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and bone marrow stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Iomab-B may avoid the side effects of non-targeted chemotherapy and external radiation on most healthy tissues while effectively killing the patient’s cancer (induction) and marrow cells (myeloablation) including those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope.
Iomab-B was licensed from the Fred Hutchinson Cancer Research Center where it was studied in nearly 300 patients, in multiple clinical trials in 6 blood cancer indications. Iomab-B is being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with active, relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. If granted approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially more efficacious manner and with a more beneficial safety profile than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency (EMA). Iomab-B also has patent terms extending to at least 2036/2037 in the US and EU. In addition, Actinium received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.
About the SIERRA Phase 3 Trial
The SIERRA trial is a 150-patient, randomized clinical trial, studying Iomab-B compared to physician’s choice of salvage therapy in patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial completed enrollment in the third quarter of 2021 with the last patient receiving a BMT in the fourth quarter of 2021. Topline data from the SIERRA trial is expected in the third quarter of 2022. In SIERRA, patients receiving Iomab-B, those achieving a remission after salvage therapy or those patients not achieving remission after salvage therapy that crossed over to receive Iomab-B were offered a BMT, which is the only treatment option with curative potential for patients with active r/r AML. The SIERRA trial is the only randomized Phase 3 trial to offer BMT to this patient population. The control arm of SIERRA included over 20 single agents or combination treatment options based on physician’s choice, including salvage chemotherapy and recently approved targeted agents including Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors as there is no standard of care for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada.