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Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) is a New York-based biopharmaceutical company focused on developing innovative targeted radiotherapies for the treatment of advanced cancers. Leveraging its proprietary delivery platform, Actinium utilizes alpha-emitting Actinium-225 and Bismuth-213, as well as certain beta-emitting radiopharmaceuticals, in conjunction with monoclonal antibodies to target and kill cancer cells. The company’s leading product candidate, Iomab™-B, is designed to prepare patients for hematopoietic stem cell transplants (bone marrow transplants) by delivering targeted radiotherapy directly to the bone marrow. Iomab™-B is currently in a pivotal, multicenter Phase 3 clinical study for refractory and relapsed acute myeloid leukemia (AML) patients over the age of 55, focusing on durable complete remission as its primary endpoint.
Actinium's second key program, Actimab-A, is undergoing clinical development in Phase 1/2 trials for newly diagnosed AML patients. This program utilizes Actinium-225 and aims to improve outcomes for patients who have failed existing therapies. Actinium is also involved in numerous partnerships and collaborations, such as with Astellas Pharma, AVEO Oncology/LG Chem Life Sciences, and others, to expand its reach in the realm of radiotherapy for solid tumors.
The company has demonstrated promising results in various studies, including the Phase 3 SIERRA trial for Iomab™-B, which showed significant improvements in survival rates among high-risk AML patients, particularly those with TP53 mutations. Further, Actinium's proprietary cyclotron technology for producing Actinium-225 at commercial scale holds potential for reducing production costs and enhancing supply for clinical and commercial purposes. With a robust pipeline and a strong patent portfolio comprising over 230 patents and applications, Actinium Pharmaceuticals continues to make strides in the field of targeted radiotherapies.
For more information, visit Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) will participate in the Alliance Global Partners' Virtual Healthcare Symposium on November 19, 2020. Chief Medical Officer Mark Berger will discuss trends in hematology ahead of the American Society of Hematology (ASH) Annual Meeting in December. Actinium's Antibody Radiation Conjugates, Iomab-B and Actimab-A, will feature in various presentations at ASH. The pivotal Phase 3 SIERRA trial for Iomab-B has over 75% enrollment, showcasing promising data. For one-on-one investor meetings, contact Clayton Robertson.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) will host a CD33 program update event featuring key opinion leaders on November 11, 2020, at 4:15 PM ET. Dr. Ehab Atallah will present data from the Actimab-A CLAG-M trial, revealing a 100% remission rate in its final dose cohort. Dr. Gary Schiller will discuss the Actimab-A venetoclax trial, emphasizing the lack of options for relapsed or refractory acute myeloid leukemia (R/R AML). Both trials have promising results and will be discussed further at the upcoming ASH Annual Meeting.
Actinium Pharmaceuticals (NYSE: ATNM) announced that 100% of evaluable patients in the third dose cohort of the Actimab-A CLAG-M Phase 1 trial achieved remission. Overall, 67% of patients across three cohorts reached either Complete Remission (CR) or Complete Remission with inadequate hematopoietic recovery (CRi). Notably, 70% of CR/CRi patients were MRD negative, showing no detectable disease. With an acceptable safety profile, a fourth dose cohort is now being explored. Results will be presented at the ASH annual meeting on December 5, 2020.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has announced two oral presentations on its Antibody Radiation Conjugate, Iomab-B, at the 2020 ASH annual meeting from December 5-8. The presentations will highlight findings from the Phase 3 SIERRA trial, focusing on Iomab-B for treating relapsed or refractory Acute Myeloid Leukemia (R/R AML). The trial shows promising results with 100% engraftment in the treatment arm and significant treatment failures in the control arm, indicating a critical need for new therapies. Safety and feasibility data from 75% of patients are expected later this quarter.
Actinium Pharmaceuticals (NYSE: ATNM) has announced the acceptance of data from its Phase 1 trial of the Actimab-A and venetoclax combination for presentation at the 2020 ASH annual meeting, taking place virtually from December 5-8, 2020. The trial showed an acceptable safety profile and a partial response in patients with relapsed/refractory acute myeloid leukemia (R/R AML) after one treatment cycle. The trial will continue to assess the combination's efficacy, with encouraging initial results suggesting potential therapeutic synergy.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) provided a corporate update detailing significant advancements in its clinical trials for targeted radiation treatments in 2020. The Iomab-B SIERRA trial has reached 75% enrollment, showcasing promising preliminary results. The Company reported a cash balance of $48.2 million as of September 30, 2020, significantly up from $9.2 million at year-end 2019. Key collaborations and upcoming milestones are expected to enhance patient outcomes in acute myeloid leukemia treatments, potentially transforming therapeutic approaches.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced a Small Business Technology Transfer grant from the National Institutes of Health to collaborate with Memorial Sloan Kettering Cancer Center on a clinical study of Iomab-ACT. This study aims to evaluate targeted lymphodepletion before administering a CD19-targeted CAR T-cell therapy. Previous results with the CAR T-therapy indicated a complete remission rate of 83%. The study will focus on safety, efficacy outcomes, and the potential for improved patient outcomes by reducing toxicities associated with traditional chemotherapy preparations.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has launched a new research and development facility in New York City, enhancing its R&D capabilities focused on Antibody Radiation Conjugates (ARCs). This facility will be led by Dr. Dale Ludwig and staffed with Ph.D. scientists to accelerate preclinical and clinical development of novel ARCs. The proprietary AWE technology platform is central to these efforts, boasting over 125 patents. The company aims to explore therapeutic combinations and improve targeted conditioning treatments in oncology.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced the activation of University of Louisville and Ochsner Clinic as trial sites for its Phase 1/2 Actimab-A and venetoclax combination trial targeting relapsed or refractory Acute Myeloid Leukemia (R/R AML) patients aged 18 and older. This addition follows a Phase 2 trial where Actimab-A achieved remission rates of 69%. The combination aims to improve response rates and duration while minimizing toxicities. Enrollment for the second dose cohort has started, with expected proof of concept results in 2021.
Actinium Pharmaceuticals (NYSE: ATNM) announced successful completion of the first dosing cohort in its Phase 1 trial combining Actimab-A and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (AML). All participants cleared safety evaluations, advancing to the second cohort. The trial aims to demonstrate synergy between Actimab-A and venetoclax, potentially enhancing remission rates in R/R AML. Preliminary results from this trial are expected in 2021. Actinium's CD33 program seeks to address significant unmet medical needs in AML treatment.
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