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Actinium Pharmaceuticals develops targeted radiotherapies for cancer using its Antibody Radiation Conjugates platform and alpha-emitting radioisotopes. Company updates commonly focus on ATNM-400, an Actinium-225 antibody radioconjugate studied in solid tumor models including prostate, lung, and breast cancer, and Actimab-A, or lintuzumab-Ac225, an Actinium-225 therapy targeting CD33 in acute myeloid leukemia.
Additional announcements describe radiochemistry work such as chelator-to-antibody ratio optimization, preclinical data presented at oncology and nuclear medicine meetings, and the company's broader radiotherapy platform across solid tumors, hematologic malignancies, and conditioning for cellular 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 (p0.0001). 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 (p0.0001), 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.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced it will present the results of its pivotal Phase 3 SIERRA trial for Iomab-B at the Transplantation & Cellular Therapy Meetings, set for 5:00 PM EST on February 18, 2023. The investor call at 6:00 PM EST will reveal topline results, showcasing Iomab-B's role as a targeted radiotherapy aimed at increasing access to bone marrow transplants for older patients with active, relapsed, or refractory acute myeloid leukemia. The trial met its primary endpoint with statistical significance, and Actinium plans to submit a Biologics License Application to the FDA following these results.
Actinium Pharmaceuticals (ATNM) has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to advance Actimab-A for treating acute myeloid leukemia (AML). The NCI will sponsor clinical trials while Actinium provides Actimab-A to clinical sites. The collaboration allows Actimab-A to be available at over 2,000 sites within leading oncology networks, aiming for its study both alone and in combination with existing therapies. Executive comments highlight the potential of Actimab-A, particularly for relapsed or refractory AML patients, and the initiative's alignment with Actinium's strategic goals.
Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) announced its management will participate in a fireside chat at the 3rd Annual B. Riley Securities Oncology Conference on January 19, 2023, at 10:30 AM EST. The event will showcase over 30 small and mid-cap healthcare companies focusing on innovative cancer therapies. Actinium is known for its advanced radiotherapy products, including I-131 apamistamab (Iomab-B), which has shown positive results in clinical trials for treating acute myeloid leukemia. The presentation will be available for replay on Actinium's website and the conference site.
Actinium Pharmaceuticals (ATNM) announced that the full data from its pivotal Phase 3 SIERRA trial of Iomab-B will be presented at the TCT Tandem Meetings on February 18, 2023. The SIERRA trial met its primary endpoint with a statistically significant p-value of <0.0001, indicating durable Complete Remission in older patients with acute myeloid leukemia. Following the presentation, the company plans a conference call at 6:00 PM EST on the same day. Iomab-B aims to improve access to bone marrow transplants, having shown increased survival rates in prior studies.