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Overview
Actinium Pharmaceuticals, Inc. (ATNM) is a New York-based biopharmaceutical company that develops advanced targeted radiotherapies to address high unmet medical needs in oncology. Utilizing pioneering antibody radiation conjugates (ARCs) and a proprietary radiotherapy delivery platform, Actinium focuses on innovative treatments for patients with relapsed or refractory cancers, particularly acute myeloid leukemia (AML) and other hematologic malignancies.
Core Technology and Product Portfolio
Actinium leverages state-of-the-art technology to couple potent radioisotopes with monoclonal antibodies, ensuring precise delivery of radiation directly to cancerous cells while safeguarding healthy tissue. This approach underpins its diverse product candidates:
- Iomab-B: A novel CD45-targeted agent specifically designed as an induction and conditioning regimen before hematopoietic stem cell transplant (BMT), offering new hope for relapsed or refractory AML patients.
- Actimab-A: An investigational therapeutic that utilizes Actinium-225 to deliver targeted radiotherapy against CD33-expressing cells, showing promise in early clinical trials for high-risk AML cases.
- Iomab-ACT: A next-generation conditioning candidate aimed at enhancing the safety and effectiveness of cell and gene therapies by facilitating targeted conditioning regimens without the toxicities associated with conventional chemotherapy.
Business Model and Market Position
Operating at the intersection of radiotherapy and immunotherapeutics, Actinium’s business model is built on robust clinical research and a comprehensive intellectual property portfolio. The company invests in rigorous clinical trials to validate the efficacy and safety of its ARCs and works closely with academic institutions and clinical researchers to refine its platforms. This strategic approach not only addresses critical gaps in current cancer treatments but also positions Actinium as a significant player in the field of nuclear medicine and oncology.
Scientific and Clinical Expertise
Actinium’s precision in dosimetry and its scientifically driven clinical trials underscore its commitment to delivering safe and effective treatments. The company meticulously measures radiation doses to ensure optimal targeting and minimal adverse effects. Through its collaborative work with leading transplant centers and clinical experts, Actinium reinforces its authoritative position within the biopharmaceutical community.
Competitive Landscape and Industry Insights
In a competitive environment characterized by rapid innovation in targeted therapies, Actinium distinguishes itself with its unique approach of combining radiotherapy with immunotherapeutic strategies. Its focus on high-risk, relapsed or refractory AML patients, along with a strong patent portfolio, enables it to offer a differentiated solution in the predominantly traditional chemotherapy landscape. This innovative methodology provides clarity and purpose to transplant conditioning and targeted treatment protocols.
Long-Term Relevance and Strategic Vision
Actinium’s strategic vision centers on developing enduring therapies that provide lasting clinical benefits. By continuously advancing its ARCs and refining its delivery systems, the company aims to maintain a long-term impact in oncology. Its comprehensive research, integration of precise radiotherapeutic methods, and expanded partnerships are designed to sustain relevance in a rapidly evolving market while addressing needs that are critical to patient care.
Conclusion
Actinium Pharmaceuticals exemplifies a forward-thinking approach in the biopharmaceutical industry by harnessing targeted radiotherapy to revolutionize the treatment of difficult-to-treat cancers. Its commitment to scientific rigor, combined with a robust clinical development framework and extensive intellectual property, establishes a solid foundation of expertise, experience, authoritativeness, and trustworthiness. This comprehensive approach not only enhances its market positioning but also provides valuable insights for investors, healthcare professionals, and stakeholders seeking an in-depth analysis of advanced oncology therapeutics.
Actinium Pharmaceuticals (NYSE: ATNM) announces a KOL investor call highlighting three major market opportunities for their targeted radiotherapies. The call features Dr. Ehab Atallah from Medical College of Wisconsin discussing Actimab-A clinical results and upcoming trials.
The company is pursuing three distinct multi-billion-dollar opportunities:
- Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies
- Actimab-A combined with PD-1 inhibitors (KEYTRUDA and OPDIVO) for solid tumors
- Iomab-ACT as a universal targeted conditioning agent for cell & gene therapies
The presentation will cover clinical proof of concept data from frontline AML trial under NCI CRADA, the new Actimab-A solid tumor program with checkpoint inhibitors, and Iomab-ACT commercial CAR-T trial, along with other 2025 milestones.
Actinium Pharmaceuticals (NYSE: ATNM) has secured a supply agreement with Eckert & Ziegler for Actinium-225 (Ac-225), a important radioisotope for targeted cancer therapies. The agreement will support the development of ATNM's lead product Actimab-A and other candidates for U.S. and international clinical trials.
Actimab-A, an Ac-225 based radiotherapy targeting CD33 receptors, is being developed for acute myeloid leukemia (AML) and other myeloid conditions. The company is advancing Actimab-A into a pivotal Phase 2/3 trial for relapsed/refractory AML and a Phase 1 trial in frontline settings with the NCI.
Additionally, ATNM is expanding Actimab-A's application to solid tumors, combining it with PD-1 checkpoint inhibitors KEYTRUDA and OPDIVO for head and neck squamous carcinoma and non-small cell lung cancer trials.
Actinium Pharmaceuticals (NYSE: ATNM) has announced a research collaboration with Memorial Sloan Kettering Cancer Center to expand Actimab-A's therapeutic applications. The partnership focuses on studying Actimab-A in combination with targeted therapies, particularly FLT3 and menin inhibitors, and assessing its activity in AML patient-derived samples.
Actimab-A has shown positive clinical results in high-risk relapsed and refractory AML patients, including those with TP53 gene mutation, prior Venetoclax treatment, and bone marrow transplant. The therapy demonstrates synergy with various inhibitors targeting mutations present in significant portions of AML cases: NPM1 and KMT2A (30%), FLT3 (25-30%), and IDH1&2 (10-20%).
The company is advancing Actimab-A into a pivotal Phase 2/3 trial in combination with CLAG-M chemotherapy for relapsed/refractory AML, and in newly diagnosed AML with Venetoclax and ASTX-727. Additionally, Actinium is developing Actimab-A for solid tumor indications, with planned trials combining it with KEYTRUDA® and OPDIVO® in HNSCC and NSCLC.
Actinium Pharmaceuticals (NYSE: ATNM) announced plans to host a KOL call featuring Dr. Ehab Atallah to discuss their pipeline developments and market opportunities. The company highlighted three potential multi-billion-dollar markets for their targeted radiotherapies:
1. Actimab-A for myeloid malignancies including AML and MDS
2. Actimab-A combined with KEYTRUDA® and OPDIVO® for solid tumors
3. Iomab-ACT as a universal targeted conditioning agent for cell & gene therapies
Key upcoming milestones include:
- Clinical proof of concept data for Actimab-A combinations in solid tumors (2H:2025)
- Initial clinical data from Actimab-A triplet combination in frontline AML (year-end 2025)
- Planned pivotal Phase 2/3 trial for Actimab-A + CLAG-M in r/r AML
- Iomab-ACT commercial CAR-T trial initiation and data expected in 2H:2025
The company reports having cash runway extending into 2027.
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.
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