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 (NYSE: ATNM) announced that 100% of evaluable patients in the third dose cohort of the Actimab-A CLAG-M Phase 1 trial achieved remission. Overall, 67% of patients across three cohorts reached either Complete Remission (CR) or Complete Remission with inadequate hematopoietic recovery (CRi). Notably, 70% of CR/CRi patients were MRD negative, showing no detectable disease. With an acceptable safety profile, a fourth dose cohort is now being explored. Results will be presented at the ASH annual meeting on December 5, 2020.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has announced two oral presentations on its Antibody Radiation Conjugate, Iomab-B, at the 2020 ASH annual meeting from December 5-8. The presentations will highlight findings from the Phase 3 SIERRA trial, focusing on Iomab-B for treating relapsed or refractory Acute Myeloid Leukemia (R/R AML). The trial shows promising results with 100% engraftment in the treatment arm and significant treatment failures in the control arm, indicating a critical need for new therapies. Safety and feasibility data from 75% of patients are expected later this quarter.
Actinium Pharmaceuticals (NYSE: ATNM) has announced the acceptance of data from its Phase 1 trial of the Actimab-A and venetoclax combination for presentation at the 2020 ASH annual meeting, taking place virtually from December 5-8, 2020. The trial showed an acceptable safety profile and a partial response in patients with relapsed/refractory acute myeloid leukemia (R/R AML) after one treatment cycle. The trial will continue to assess the combination's efficacy, with encouraging initial results suggesting potential therapeutic synergy.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM) provided a corporate update detailing significant advancements in its clinical trials for targeted radiation treatments in 2020. The Iomab-B SIERRA trial has reached 75% enrollment, showcasing promising preliminary results. The Company reported a cash balance of $48.2 million as of September 30, 2020, significantly up from $9.2 million at year-end 2019. Key collaborations and upcoming milestones are expected to enhance patient outcomes in acute myeloid leukemia treatments, potentially transforming therapeutic approaches.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced a Small Business Technology Transfer grant from the National Institutes of Health to collaborate with Memorial Sloan Kettering Cancer Center on a clinical study of Iomab-ACT. This study aims to evaluate targeted lymphodepletion before administering a CD19-targeted CAR T-cell therapy. Previous results with the CAR T-therapy indicated a complete remission rate of 83%. The study will focus on safety, efficacy outcomes, and the potential for improved patient outcomes by reducing toxicities associated with traditional chemotherapy preparations.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has launched a new research and development facility in New York City, enhancing its R&D capabilities focused on Antibody Radiation Conjugates (ARCs). This facility will be led by Dr. Dale Ludwig and staffed with Ph.D. scientists to accelerate preclinical and clinical development of novel ARCs. The proprietary AWE technology platform is central to these efforts, boasting over 125 patents. The company aims to explore therapeutic combinations and improve targeted conditioning treatments in oncology.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced the activation of University of Louisville and Ochsner Clinic as trial sites for its Phase 1/2 Actimab-A and venetoclax combination trial targeting relapsed or refractory Acute Myeloid Leukemia (R/R AML) patients aged 18 and older. This addition follows a Phase 2 trial where Actimab-A achieved remission rates of 69%. The combination aims to improve response rates and duration while minimizing toxicities. Enrollment for the second dose cohort has started, with expected proof of concept results in 2021.
Actinium Pharmaceuticals (NYSE: ATNM) announced successful completion of the first dosing cohort in its Phase 1 trial combining Actimab-A and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (AML). All participants cleared safety evaluations, advancing to the second cohort. The trial aims to demonstrate synergy between Actimab-A and venetoclax, potentially enhancing remission rates in R/R AML. Preliminary results from this trial are expected in 2021. Actinium's CD33 program seeks to address significant unmet medical needs in AML treatment.
Actinium Pharmaceuticals (NYSE: ATNM) announced the successful completion of the Phase 1 Actimab-A CLAG-M combination trial at the Medical College of Wisconsin for patients with Relapsed or Refractory Acute Myeloid Leukemia (AML). The third dosing cohort completed treatment with a 0.75 uCi/kg dose, all passing initial safety evaluations. Previous results showed an 86% complete remission rate in the second cohort with 71% achieving negative minimal residual disease status. Full trial results are expected by year-end, indicating potential for advancement depending on FDA clearance.
Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced that CEO Sandesh Seth will present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14 at 2:00 PM EST. The presentation will be available on the company's investor relations website. Actinium is advancing Antibody Radiation-Conjugates aimed at improving conditioning before bone marrow transplants (BMT) with its lead candidate Iomab-B, currently under study in the pivotal Phase 3 SIERRA trial for elderly patients with relapsed or refractory acute myeloid leukemia.