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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 (NYSE: ATNM) announced a research collaboration with Astellas Pharma to develop targeted radiotherapies using its Antibody Warhead Enabling (AWE) technology. This partnership aims to utilize Actinium-225 in combination with selected targeting agents from Astellas, contributing to the latter's Rx+ ® initiative for theranostics. Actinium’s AWE platform, protected by a robust intellectual property portfolio, positions the company favorably for this collaboration. Actinium plans to leverage its clinical experience and laboratory capabilities to enhance targeted therapies.
Actinium Pharmaceuticals (ATNM) announced positive interim results from the pivotal Phase 3 SIERRA study for Iomab-B, designed for bone marrow transplant conditioning in older patients with relapsed or refractory AML. The independent Data Monitoring Committee recommended the trial continue, as 100% of patients receiving Iomab-B proceeded to transplant versus 16% in the control arm. Safety data presented at the ASH 2020 Annual Meeting indicated lower rates of serious adverse events in the Iomab-B group. The trial aims to complete enrollment of 150 patients, with over 75% already enrolled.
Actinium Pharmaceuticals (NYSE: ATNM) participated in the virtual Targeted Radiopharmaceuticals Summit from December 8-10, 2020. CEO Sandesh Seth highlighted the company's leadership in targeted radiotherapy and provided updates on its promising clinical programs for Acute Myeloid Leukemia (AML), particularly Iomab-B and Actimab-A. The company aims to leverage its proprietary AWE technology platform for novel targeted therapies. Notably, the pivotal Phase 3 SIERRA trial for Iomab-B is over 75% enrolled, with significant safety data previously presented at major oncology meetings.
Actinium Pharmaceuticals (NYSE: ATNM) announced promising results for its Actimab-A and venetoclax combination therapy in a Phase 1 trial for relapsed or refractory Acute Myeloid Leukemia (AML). Presented at the ASH annual meeting, data indicated one patient achieved a complete remission after the first cycle, with no significant toxicity reported. The trial has progressed to the second dose cohort, reinforcing Actinium's clinical development strategy aimed at enhancing therapeutic efficacy while minimizing side effects.
Actinium Pharmaceuticals (NYSE: ATNM) presented interim data from its pivotal Phase 3 SIERRA trial in relapsed or refractory Acute Myeloid Leukemia at the ASH annual meeting. With 75% patient enrollment, 100% of 49 patients receiving Iomab-B proceeded to Bone Marrow Transplant (BMT), compared to 16% in the control arm. Among those who crossed over from the control group, 100% also proceeded to BMT. The trial shows a durable Complete Remission potential of 77% in the Iomab-B arm versus 12% in the control, highlighting Iomab-B's effectiveness in older, at-risk patients.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced promising safety data from its pivotal Phase 3 SIERRA trial of Iomab-B for treating relapsed or refractory Acute Myeloid Leukemia (R/R AML), presented at the 2020 ASH annual meeting. Data from 110 patients indicated that Iomab-B significantly reduces the rates of sepsis, febrile neutropenia, mucositis, and non-relapse transplant-related mortality compared to traditional therapies. Actinium remains optimistic about Iomab-B's effectiveness leading into the upcoming ad hoc interim analysis for SIERRA, with 75% patient enrollment.
Actinium Pharmaceuticals (NYSE: ATNM) announced interim results from its Actimab-A CLAG-M Phase 1 trial for relapsed/refractory Acute Myeloid Leukemia (AML) at the ASH annual meeting. In the third dose cohort, 100% of evaluable patients achieved remission. Overall, 67% of patients across the first three cohorts attained Complete Remission (CR) or Complete Remission with incomplete hematopoietic recovery (CRi). Furthermore, 83% of patients with three or fewer prior treatments achieved CR/CRi, with 70% of these patients being MRD negative. The trial is moving to a fourth cohort with a higher dose.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) has appointed Mary Mei Chen, M.D., Ph.D., as Vice President of Clinical Development effective immediately. Dr. Chen will oversee the clinical development of Actinium's CD33 program, including combination trials involving Actimab-A in relapsed and refractory Acute Myeloid Leukemia (R/R AML). With over 20 years of experience, including pivotal Phase 3 trials, Dr. Chen aims to advance targeted radiotherapy approaches to improve R&D efforts for better patient outcomes in AML and other hematologic malignancies.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced significant advancements in its intellectual property portfolio for apamistamab, a CD45 targeting antibody, and the Antibody Radiation Conjugate (ARC) linked with iodine-131. The company holds patents protecting its core products, notably Iomab-B, until 2037 in the US and until 2036 in Europe, which bolsters its market position. Iomab-B is currently under investigation in the Phase 3 SIERRA trial for treating relapsed or refractory Acute Myeloid Leukemia, with over 75% enrollment. Actinium aims to improve patient outcomes by minimizing the side effects of traditional chemotherapy in conditioning protocols.
Actinium Pharmaceuticals (NYSE: ATNM) has appointed Dr. Avinash Desai as Executive Vice President of Clinical Development, Operations and Medical Affairs. Dr. Desai will lead medical affairs for Iomab-B and Actimab-A and contribute to strategic development of Iomab-B's clinical programs. His extensive experience in hematology and oncology, including successful product launches at GSK, positions him well for this role. The company looks to advance clinical trials, particularly the SIERRA trial for Iomab-B, which is in its final phases, enhancing its potential market impact.
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