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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 presented groundbreaking preclinical data on HER3-targeted radiotherapy at the AACR 2023 Annual Meeting, reporting a significant reduction in tumor volume (p<0.0001) for ovarian cancer when conjugated to Actinium-225 or Lutetium-177, outperforming bevacizumab.
The HER3 target is frequently overexpressed in various solid tumors and linked to poor survival rates. The results indicated effective target engagement and cytotoxic activity in preclinical models for both ovarian and colorectal cancers.
Actinium aims to address high unmet medical needs, highlighting the potential for broad application in different oncology indications. The data showcases Actinium's innovative approach, reaffirming its commitment to developing efficient targeted therapies.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) recently showcased promising data on Actimab-A, a targeted radiotherapy, at the AACR 2023 Annual Meeting in Orlando, Florida. The data highlights Actimab-A's ability to effectively deplete myeloid derived suppressor cells (MDSCs), which are known to inhibit immune responses in various cancers. Key findings include:
- Actimab-A demonstrated superior effectiveness in depleting MDSCs compared to other treatments like Mylotarg.
- Data supported its potential as a backbone therapy to enhance the efficacy of immunotherapies across multiple solid tumor types.
- The treatment showed promise in boosting the antitumor activity of immunotherapies, including checkpoint inhibitors.
Actinium is actively pursuing further development of Actimab-A, aiming to leverage its capabilities in combination therapies.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) announced positive results from the pivotal Phase 3 SIERRA trial of Iomab-B in relapsed/refractory acute myeloid leukemia (r/r AML) patients aged 55 and older, achieving a durable complete remission (dCR) rate of 75% (44/59 patients) and doubling overall survival at 1 year compared to the control arm. The company plans to submit a Biologics License Application (BLA) for Iomab-B in the second half of 2023 and is launching an Early Access Program. Actimab-A also demonstrated promising 1-year survival rates in a trial subset. With a strong financial position of $108.9 million, Actinium aims to fund operations through 2025.
Coya Therapeutics, Inc. (NASDAQ: COYA) has appointed Dr. Arun Swaminathan as Chief Business Officer. With over 20 years of experience, he will drive business development and partnerships in Coya’s clinical-stage biotechnology pipeline. Notably, during his tenure at Alteogen, he facilitated deals worth $6B and at Actinium Pharmaceuticals, he executed a $452M deal. CEO Howard H. Berman expressed confidence in Swaminathan’s ability to enhance Coya's strategic direction, particularly following recent positive clinical data. Coya focuses on treatments targeting systemic inflammation and neuroinflammation through its Treg-enhancing therapeutic platforms.
Actinium Pharmaceuticals (NYSE: ATNM) announced the acceptance of two abstracts for presentation at the AACR 2023 Annual Meeting, scheduled for April 14-19, 2023, in Orlando, Florida. The abstracts focus on the novel application of Actimab-A to deplete immunosuppressive myeloid-derived suppressor cells (MDSCs) and the effectiveness of HER3-targeting radiotherapy in solid tumors, showcasing potent anti-cancer activity. Actinium's Chairman, Sandesh Seth, emphasized the company's commitment to advancing targeted radiotherapies to address significant medical needs, supported by their recent CRADA with the NCI for developing Actimab-A in various clinical trials.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) announced its participation in Oppenheimer's 33rd Annual Healthcare Conference from March 13-17, 2023. The management team will present key updates, including the success of the pivotal Phase 3 SIERRA trial for Iomab-B, which achieved significant remissions in elderly patients with relapsed acute myeloid leukemia (AML). The Company has also signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to advance Actimab-A. The virtual presentation is scheduled for March 15, 2023, at 2:40 PM ET. More details can be found on Actinium's website.
Actinium Pharmaceuticals (NYSE: ATNM) announced a KOL webinar on February 28, 2023, to discuss the positive results of the pivotal Phase 3 SIERRA trial of Iomab-B. This first-in-class targeted radiotherapy significantly improved access to bone marrow transplants (BMT) for older patients with Relapsed or Refractory Acute Myeloid Leukemia (r/r AML). With a 75% post-BMT complete remission rate and a 78% reduction in non-remission events, Iomab-B's efficacy was statistically significant (p<0.0001). Actinium plans to file a Biologics License Application for Iomab-B in the second half of 2023. The company holds approximately $100 million in cash, expected to fund operations through 2025.
Actinium Pharmaceuticals, Inc. (AMEX:ATNM) announced positive results from its pivotal Phase 3 SIERRA trial of Iomab-B in patients aged 55 and older with active relapsed or refractory acute myeloid leukemia (r/r AML). The primary endpoint of durable Complete Remission (dCR) at 6-months was met with high statistical significance (p<0.0001), showing 22% of patients achieved dCR compared to 0% in the control arm. Secondary endpoints also demonstrated significant improvements in Event-Free Survival (EFS) and overall survival. Notably, Iomab-B showed a favorable safety profile with lower rates of sepsis and other adverse events. A Biologics License Application is planned for 2023.
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