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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 positive results from its Phase 1b trial of the Actimab-A + CLAG-M combination therapy for relapsed or refractory acute myeloid leukemia (r/r AML) at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting. The study showcased high response rates, bone marrow transplant access, and improved survival outcomes, especially in high-risk patients, including those with TP53 mutations and previous venetoclax treatment. The combination therapy demonstrated no significant safety concerns for major organs and used a validated pharmacokinetic model to estimate biodistribution. The presentation highlighted the dosing, efficacy, and safety profile, with 64% of eligible patients proceeding to bone marrow transplants and median overall survival reaching up to 24 months.
Actinium Pharmaceuticals presented data from the Phase 3 SIERRA trial of Iomab-B at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting.
Iomab-B, a CD45 targeting ARC, significantly improved survival for high-risk relapsed or refractory AML patients, including those with TP53 mutations. The trial achieved its primary endpoint of durable Complete Remission with high statistical significance (p<0.0001). Patients receiving Iomab-B had a median OS of 5.49 months compared to 1.66 months for the control group.
Actinium also showcased its novel linker technology, demonstrating high tumor uptake and in vivo stability in preclinical models, with significantly lower kidney and liver uptake compared to standard DOTA linkers. This technology supports the expansion of Actinium's ARC pipeline for solid tumors.
The SIERRA trial involved 153 patients, with Iomab-B delivering targeted radiation more effectively and safely than total body irradiation, while sparing healthy organs.
Actinium has two U.S. patents for its linker technology extending into 2043, with a pending international application.
Actinium Pharmaceuticals will host a KOL webinar on May 20, 2024, at 8:00 AM ET to discuss the Iomab-ACT commercial CAR T-cell therapy trial being conducted at the University of Texas Southwestern (UTSW). Dr. Farrukh Awan, an expert in leukemia and lymphoma treatment, will join as the principal investigator. Iomab-ACT, an ARC targeting CD45, aims to replace non-targeted chemotherapy in conditioning prior to cell and gene therapies. Phase 1 trial results showed no immune effector cell-associated neurotoxicity syndrome (ICANS) in treated patients and minimal Cytokine Release Syndrome (CRS). The CAR-T market, projected to grow at an 11% CAGR, presents a significant opportunity for Iomab-ACT, which targets an addressable patient population expected to reach 93,000 in the U.S. by 2030.
Actinium Pharmaceuticals announced that the Phase 3 SIERRA trial results of Iomab-B will be presented at the EHA 2024 Congress. The trial demonstrated significant survival benefits in older patients with relapsed or refractory acute myeloid leukemia (r/r AML) receiving an Iomab-B led bone marrow transplant (BMT). Patients with TP53 mutations saw a median overall survival of 5.49 months compared to 1.66 months for those not receiving Iomab-B. The trial enrolled high-risk patients and showed 92% 1-year survival and 69% 2-year survival rates in those receiving Iomab-B led BMT.
Actinium Pharmaceuticals announced that multiple abstracts highlighting its Antibody Radiation Conjugates Iomab-B and Actimab-A, along with novel linker technology for solid tumors, have been accepted for presentation at the 2024 Society of Nuclear Medicine & Molecular Imaging Annual Meeting. The abstracts feature improved survival with both Iomab-B and Actimab-A in high-risk acute myeloid leukemia patients, including TP53 mutations. Actinium's presence at the SNMMI showcases its leadership in developing ARCs, with a focus on targeted radiotherapy for blood cancers and solid tumors.
Actinium Pharmaceuticals, Inc. announced a KOL webinar to discuss its Iomab-ACT trial with a leading FDA approved CAR T-cell therapy at the University of Texas Southwestern. The webinar will highlight the potential billion-dollar market opportunity in lymphodepletion. Dr. Farrukh Awan will lead the trial, aiming to study Iomab-ACT with an FDA approved CAR-T cell therapy for the first time. The company presented positive phase 1 trial results at the Tandem Meetings, showing promising safety and efficacy profiles. With the expanding CAR-T market and the need for improved conditioning in cellular therapy, Iomab-ACT presents a revenue opportunity in line with the growing patient population for cell and gene therapies.
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