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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) announced acceptance of three abstracts from its pivotal Phase 3 SIERRA trial for Iomab-B at the SNMMI 2021 Annual Meeting, scheduled for June 11-14. Iomab-B targets conditioning prior to bone marrow transplantation for patients aged 55 and over with relapsed or refractory acute myeloid leukemia. The trial reports a 25%, 50%, and 75% enrollment, showcasing Iomab-B's potential as a best-in-class treatment with low transplant-related mortality. The findings emphasize the significance of Iomab-B in improving BMT outcomes.
Actinium Pharmaceuticals (NYSE: ATNM) will present its Iomab-ACT program at the Cell & Gene Meeting on the Mediterranean from April 6-9, 2021. Iomab-ACT is a lower-dose radiation treatment aimed at achieving lymphodepletion before CAR-T therapies and gene therapies. The company collaborates with Memorial Sloan Kettering Cancer Center for a pioneering trial targeting CD19 CAR T-cell therapy, and with UC Davis for anti-HIV stem cell gene therapy. Actinium continues to advance its clinical pipeline focusing on improving patient outcomes in hematologic malignancies.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) announced the completion of patient enrollment in the second dose cohort of the Phase 1 portion of its Actimab-A and venetoclax combination trial for relapsed/refractory Acute Myeloid Leukemia (r/r AML). This trial aims to determine the maximum tolerable dose of Actimab-A before progressing to Phase 2. Initial results from the first dose cohort indicated significant patient responses, with one complete remission and another partial response noted. Actinium plans to present further data in the latter half of 2021.
Actinium Pharmaceuticals (NYSE: ATNM) announced the commencement of patient enrollment in a Phase 1 study of Iomab-ACT for targeted conditioning before treatment with Memorial Sloan Kettering's CD19 CAR T-cell therapy. Iomab-ACT, a low-dose version of the Phase 3 candidate Iomab-B, aims to reduce toxicities associated with CAR T-cell therapy. The study, supported by NIH grant funding, follows promising preclinical data and previous clinical observations. Initial patient treatments are anticipated in Q2 2021, with proof-of-concept data expected later in the year.
Actinium Pharmaceuticals (NYSE: ATNM) announced that preclinical data for its Ac-225-based CD45-targeted conditioning agent has been accepted for presentation at the AACR 2021 annual meeting from April 10-15, 2021. This data indicates selective accumulation in immune cell organs, demonstrating a dose-dependent response for both low and high doses, applicable for therapies like CAR-T and bone marrow transplants. Actinium's Iomab-B remains in pivotal Phase 3 trials while they leverage their Antibody Warhead Enabling technology for enhanced therapeutic options.
Actinium Pharmaceuticals (NYSE: ATNM) announced Mark Kubik's appointment as Chief Business Officer, effective immediately. Kubik, formerly with OncoImmune, will lead business development, focusing on partnerships and advancing Actinium's AWE technology and pipeline of antibody radiation conjugates (ARCs). His extensive background includes a successful acquisition of OncoImmune by Merck for $425 million. Actinium expects significant developments in 2021, including completing SIERRA enrollment and proof of concept data across multiple clinical programs, enhancing its research capabilities and portfolio.
Actinium Pharmaceuticals (NYSE: ATNM) announced its participation in the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The company's executive team will hold one-on-one meetings with attendees. Actinium is focused on developing ARCs—Antibody Radiation-Conjugates for targeted conditioning in cancer treatments, particularly for Bone Marrow Transplants. Their lead candidate, I-131 apamistamab (Iomab-B), is in a pivotal Phase 3 trial for elderly patients with relapsed or refractory acute myeloid leukemia. The trial is over 75% enrolled, with positive early data reported at major conferences.
Actinium Pharmaceuticals (ATNM) showcased its pivotal Phase 3 SIERRA trial for Iomab-B at the 2021 TCT Annual Meeting, highlighting significant progress in targeted conditioning for bone marrow transplants. Key findings include a 100% BMT rate for Iomab-B patients versus 18% for conventional therapy. Additionally, 79% of patients in the SIERRA trial proceeded to BMT, indicating strong efficacy. The company's focus on advancing Iomab-ACT and future milestones suggests a positive outlook for 2021, with expectations of completing enrollment and presenting further trial results.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) will participate in the BIO CEO & Investor conference from February 16-18, 2021. Actinium's executive team will hold one-on-one meetings with attendees through the BIO One-on-One Partnering™ system. The company focuses on developing Antibody Radiation-Conjugates (ARCs) for treating cancers, including its lead product, I-131 apamistamab (Iomab-B), which is in a pivotal Phase 3 trial for elderly patients with relapsed or refractory acute myeloid leukemia. This trial is over 75% enrolled and has positive preliminary data from prior meetings.
Actinium Pharmaceuticals (NYSE: ATNM) announced its participation in the B. Riley Oncology Investor Conference, scheduled virtually from January 20-21, 2021. Key executives, including Sandesh Seth (Chairman and CEO), Dr. Mark Berger (Chief Medical Officer), and Dr. Dale Ludwig (Chief Scientific Officer), will engage in a moderated discussion led by analyst Justin Walsh. The chat is set for January 21 at 3:30 p.m. ET. Additionally, the executive team is open for one-on-one meetings with attendees.
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