Actinium Pharmac Stock Price, News & Analysis

Actinium Pharmaceuticals (NYSE: ATNM) has announced a new clinical trial program combining Actimab-A with PD-1 checkpoint inhibitors KEYTRUDA® and OPDIVO® for solid tumors. The trials aim to improve patient outcomes by targeting Myeloid Derived Suppressor Cells (MDSCs) in the tumor microenvironment, which currently limit PD-1 inhibitors' effectiveness.

The program includes controlled, head-to-head trials focusing on Head and Neck Squamous Cell Carcinoma (HNSCC) and Non-Small Cell Lung Cancer (NSCLC). Initial proof of concept clinical data is expected in the second half of 2025. The company estimates a potential treatment population exceeding 500,000 patients.

The trials will evaluate safety, tolerability, Overall Response Rate (ORR), Progression Free Survival (PFS), and Overall Survival (OS). Actimab-A, which has been studied in over 150 AML patients, delivers Actinium-225, targeting CD33-expressing MDSCs.

Actinium Pharmaceuticals (NYSE: ATNM) has published results in the journal Leukemia for its Actimab-A + CLAG-M combination therapy trial in relapsed/refractory acute myeloid leukemia (r/r AML) patients. The trial demonstrated significant outcomes including:

• 18.4 months median Overall Survival in patients with 1-2 prior therapy lines
• 75% measurable residual disease negativity (MRD-) across all patients
• Strong efficacy in high-risk patients: 83.3% MRD- in TP53 mutation cases and 100% in prior Venetoclax therapy patients
• 71% of eligible patients received bone marrow transplant with 24.05 months median survival

The company plans to initiate a pivotal Phase 2/3 trial in 2025, comparing Actimab-A + CLAG-M versus CLAG-M alone in r/r AML patients. The treatment showed particular promise for high-risk patients, with results significantly exceeding historical survival rates of 2.4-4.6 months in Venetoclax-failed patients.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM), a leader in targeted radiotherapies, has announced its participation in the upcoming 37th Annual Roth Conference, scheduled for March 16th to 18th, 2025.

The company's management team will be available for one-on-one meetings with investors on March 17th and 18th. Interested investors can arrange meetings through their ROTH representative or by submitting a registration request at Roth2025Registration.

Actinium Pharmaceuticals (NYSE: ATNM) has initiated a groundbreaking clinical trial under its CRADA with the National Cancer Institute, testing a first-ever triplet combination therapy for newly diagnosed AML patients. The trial (NCT06802523) will evaluate Actimab-A in combination with Venetoclax and ASTX-727.

Actimab-A, a humanized anti-CD33 antibody with Actinium-225 payload, will be combined with Venetoclax (a Bcl-2 inhibitor) and ASTX-727 (an oral hypomethylating agent). The study aims to assess Complete Remission rates and safety parameters, with initial clinical data expected in 2H:2025.

Previous Phase 1 trials demonstrated Actimab-A's mutation agnostic properties and synergistic potential. The company aims to establish Actimab-A as a backbone therapy for AML treatment, targeting over 100,000 patients with AML and other myeloid malignancies in the U.S. and major international markets.

Actinium Pharmaceuticals (NYSE: ATNM) reported key developments and financial results for Q3 2024. The company aligned with FDA on Phase 2/3 trial for Actimab-A, and received FDA clearance for two Iomab-ACT INDs. The company reported cash and equivalents of $78.6 million, expected to fund operations into 2027. Q3 financial highlights include research and development expenses of $9.8 million, down from $11.6 million year-over-year, and a net loss of $11.6 million, improved from $13.3 million in Q3 2023. The company reduced headcount by 20% in Q3, expecting to save approximately $3.7 million in personnel expenses for 2025.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced the publication of Phase 3 SIERRA trial results for Iomab-B in the Journal of Clinical Oncology. The trial, involving 153 patients aged 55+ with relapsed/refractory Acute Myeloid Leukemia (r/r AML), compared Iomab-B with bone marrow transplant (BMT) to standard chemotherapy and BMT. Key findings include:

1. Primary endpoint of durable Complete Remission achieved (p<0.0001)
2. Significant improvement in Event-Free Survival (p<0.0001)
3. Overall survival endpoint not met due to high crossover rate
4. Improved outcomes for patients with TP53 mutation and those aged 65+

Despite positive results, the FDA requires an additional Phase 3 trial demonstrating overall survival benefit for BLA filing. Actinium plans to seek a strategic partner for Iomab-B's further development in the U.S.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced that the FDA has determined the Phase 3 SIERRA trial for Iomab-B is not adequate to support a Biologics License Application (BLA) filing, despite meeting its primary endpoint with statistical significance. The FDA requires an additional head-to-head randomized clinical trial demonstrating overall survival benefit to support a BLA filing.

Key points:

• Actinium will request a meeting with the FDA to discuss specifics of the additional trial
• The company will seek a strategic partner for Iomab-B in the U.S. after completing FDA interactions
• Actinium will focus development efforts on Actimab-A, Iomab-ACT, and preclinical programs

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has expanded its patent coverage for Iomab-ACT, a targeted radiotherapy conditioning agent, with the issuance of U.S. Patent No. 11,912,780. This patent, extending to 2040, covers methods using Iomab-ACT for conditioning patients before gene-edited hematopoietic stem cell therapy for non-malignant disorders such as sickle cell disease, SCID, β-thalassemia, and Fanconi's anemia.

Iomab-ACT targets CD45, aiming to replace non-targeted chemotherapy in conditioning for cell and gene therapies. The company is conducting clinical trials with Memorial Sloan Kettering Cancer Center, the University of Texas Southwestern, and Columbia University to explore Iomab-ACT's potential in various applications, including CAR-T therapy and sickle cell disease treatment.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced FDA clearance for an IND application to study Iomab-ACT for targeted conditioning prior to bone marrow transplant (BMT) in sickle cell disease patients. The study, in collaboration with Columbia University, aims to evaluate Iomab-ACT's safety and potentially inform future gene therapy conditioning trials. Iomab-ACT, an Antibody Radiation Conjugate targeting CD45, could replace current non-targeted chemotherapy and total body irradiation conditioning methods, potentially reducing severe side effects and broadening access to curative cellular therapies. This initiative addresses the high unmet need among approximately 100,000 U.S. sickle cell patients annually. The study aligns with Actinium's strategy to expand Iomab-ACT's applications in transplant, cell therapy, and gene therapy conditioning, tapping into a growing market for CAR-T and gene therapies expected to reach 93,000 U.S. patients by 2030.