- ATNM-400 is a novel, non-PSMA targeting, first-in-class Actinium-225 radiotherapy for prostate cancer with initial preclinical results to be presented at the AACR Annual Meeting - Actinium is establishing radiopharmaceutical manufacturing infrastructure in 2025 to support expanding clinical trials and to leverage its proprietary Actinium-225 cyclotron manufacturing technology - Data from several clinical trials expected in 2H:2025 across myeloid malignancies, solid tumors and cell and gene therapy conditi ...

- Company to highlight recent significant progress made with its Actimab-A and Iomab-ACT clinical programs, leading-edge R&D and radiopharmaceutical manufacturing infrastructure - Revitalized clinical programs focused on 3 separate multi-billion-dollar market opportunities in myeloid malignancies, solid tumors and cell & gene therapy conditioning with clinical data expected in 2025 supporting each addressable market - Presentation follows Investor KOL Event and Company Update on March 25th NEW YORK, March 2 ...

Core Insights - Actinium Pharmaceuticals is presenting three multi-billion-dollar market opportunities for its products Actimab-A and Iomab-ACT in the treatment of myeloid malignancies, solid tumors, and cell & gene therapy conditioning [1][2] Group 1: Actimab-A Developments - Actimab-A is being positioned as a mutation-agnostic backbone therapy for myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across various treatment settings [2][3] - Clinical results for Actimab-A show high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity in relapsed/refractory AML patients, leading to improved survival outcomes [3][4] - A pivotal Phase 2/3 clinical trial for Actimab-A in relapsed/refractory AML is planned, along with trials under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) [1][3] Group 2: Solid Tumor Program - Actinium is advancing a solid tumor program for Actimab-A, which includes head-to-head clinical trials evaluating its combination with PD-1 inhibitors like KEYTRUDA and OPDIVO against these inhibitors alone [1][3] - The trials will initially focus on patients with head and neck squamous cell carcinoma and non-small cell lung cancer [1] Group 3: Iomab-ACT and Future Prospects - Iomab-ACT is being developed as a universal targeted conditioning agent to enhance patient access to cell and gene therapies and improve outcomes [2][3] - Actinium is also seeking a strategic partner for Iomab-B, which serves as an induction and conditioning agent prior to bone marrow transplant in patients with relapsed/refractory AML [4]

NEW YORK, March 24, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today announced it has entered into an agreement for the supply of Actinium-225 (Ac-225) with Eckert & Ziegler. Under this agreement, Actinium Pharmaceuticals will have access to Eckert & Ziegler's high-quality Actinium-225 to further develop its lead product Actimab-A as well as additional early and late-stage development candidate ...

NEW YORK, March 20, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today announced that is has entered into a sponsored research agreement with Memorial Sloan Kettering Cancer Center (MSKCC) to expand Actimab-A's mutation agnostic mechanism of action. The collaboration has two specific objectives. The first objective is to study Actimab-A in combination with targeted therapies including FLT3 and me ...

Core Insights - Actinium Pharmaceuticals is conducting clinical trials to evaluate the efficacy of Actimab-A in combination with PD-1 inhibitors KEYTRUDA® and OPDIVO® to improve patient outcomes in solid tumors [1][4][6] - The trials are based on the premise that Actimab-A can selectively target and deplete Myeloid Derived Suppressor Cells (MDSCs) that express the CD33 antigen, which are known to limit the effectiveness of PD-1 inhibitors [1][2][3] - Initial proof of concept data from these trials is expected in 2025, potentially opening a multi-billion-dollar market opportunity for Actimab-A [1][4][6] Company Overview - Actinium Pharmaceuticals is a pioneer in targeted radiotherapies, focusing on improving patient outcomes through innovative treatments [7] - Actimab-A, the company's lead product, utilizes Actinium-225, a potent alpha-emitter radioisotope, to induce lethal DNA damage in targeted cells [3][7] - The company is also advancing Actimab-A in acute myeloid leukemia (AML) and other myeloid malignancies, with promising results in clinical trials [7] Clinical Trials and Strategy - The solid tumor program includes head-to-head trials comparing Actimab-A combined with KEYTRUDA® or OPDIVO® against the respective PD-1 inhibitors alone [4][6] - Targeted tumors include Head and Neck Squamous Cell Carcinoma (HNSCC) and Non-Small Cell Lung Cancer (NSCLC), with trials focusing on adults with PD-L1 expression [4] - Key endpoints for the trials include Overall Response Rate (ORR), Progression Free Survival (PFS), and Overall Survival (OS), along with biomarker data on CD33+ MDSC depletion and T-Cell activity [4] Market Potential - The combination therapy approach aims to address the unmet needs of patients whose cancers progress despite PD-1 checkpoint inhibitors, representing a treatment population exceeding 500,000 patients [6][7] - The potential market for Actimab-A as a combination therapy with PD-1 inhibitors is estimated to be multi-billion dollars, highlighting its significance in the oncology landscape [1][6][7]

Core Insights - Actinium Pharmaceuticals has reported promising results from a clinical trial of Actimab-A in combination with CLAG-M for patients with relapsed or refractory acute myeloid leukemia (r/r AML), showing a median overall survival of 18.4 months [1][5] - The combination therapy demonstrated high rates of complete remissions and measurable residual disease negativity, particularly in high-risk patients, indicating its mutation agnostic potential [1][3] - Actinium plans to initiate a pivotal Phase 2/3 trial to further evaluate the efficacy of Actimab-A + CLAG-M in r/r AML patients [3][4] Clinical Trial Results - The trial showed a median overall survival of 18.4 months for patients who had received 1 or 2 lines of prior therapy, compared to historical data showing a median survival of 13.3 months with CLAG-M alone [5] - 52% of patients in the trial had TP53 mutations, and 75% of all patients achieved measurable residual disease negativity [5] - Among patients with prior Venetoclax therapy, 100% achieved measurable residual disease negativity, highlighting the effectiveness of the combination therapy [5] Future Developments - Actinium has aligned with the FDA to conduct a pivotal Phase 2/3 trial, which will include a randomized comparison of Actimab-A + CLAG-M versus CLAG-M alone [3][4] - The trial aims to optimize the dosing of Actimab-A and is expected to begin in 2025 [3] - Actinium is also engaged in a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute to explore additional combinations for AML treatment [6]

Company Overview - Actinium Pharmaceuticals, Inc. is a pioneer in the development of targeted radiotherapies aimed at improving patient outcomes [3] - The company is advancing its lead product candidate, Actimab-A, which targets CD33 and is being developed as a potential backbone therapy for acute myeloid leukemia (AML) and other myeloid malignancies [3] - Actinium holds 230 patents and patent applications, including several related to the manufacture of the isotope Ac-225 in a cyclotron [3] Product Development - Actimab-A has shown potential activity in relapsed and refractory AML patients when combined with the chemotherapy CLAG-M, achieving high rates of Complete Remissions (CR) and improved survival outcomes [3] - The company is advancing Actimab-A to a Phase 2/3 trial and is collaborating with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) [3] - The first clinical trial under the CRADA will evaluate a triplet combination of Actimab-A, Venetoclax, and ASTX-727 in frontline AML patients [3] Future Initiatives - Iomab-ACT, a next-generation conditioning candidate, is being developed to enhance patient access and outcomes for cell and gene therapies [3] - Iomab-B is an induction and conditioning agent for bone marrow transplant in patients with relapsed/refractory AML, for which Actinium is seeking a strategic partner in the U.S. [3] - The company's R&D efforts are also focused on advancing several preclinical programs for solid tumor indications [3] Conference Participation - Actinium will participate in the 37th Annual Roth Conference from March 16th to 18th, 2025, with management available for one-on-one meetings on March 17th and 18th [1][2]

Core Viewpoint - Actinium Pharmaceuticals has initiated the first clinical trial for Actimab-A under a Cooperative Research and Development Agreement with the National Cancer Institute, focusing on a triplet combination therapy for acute myeloid leukemia (AML) patients [1][2][3] Group 1: Clinical Trial Details - The trial (NCT06802523) will evaluate the combination of Actimab-A, Venetoclax, and ASTX-727 in frontline AML patients, aiming to assess the rate and duration of Complete Remission (CR) and safety [1][2] - Actimab-A is a humanized anti-CD33 antibody conjugated to Actinium-225, targeting CD33, which is expressed on myeloid blasts in AML patients [1][4] - The triplet regimen is designed for outpatient administration, as both Venetoclax and ASTX-727 are oral agents, and Actimab-A does not require patient isolation [2][3] Group 2: Mechanism and Efficacy - Actimab-A's mechanism is mutation agnostic, potentially improving outcomes for patients with high-risk features, such as TP53 mutations, where current therapies have limited success [2][3] - Previous studies indicated that Actimab-A in combination with Venetoclax was well tolerated, with manageable adverse events, and preclinical studies suggested a synergistic effect by depleting MCL-1, which mediates resistance to Venetoclax [2][5] Group 3: Strategic Vision and Market Potential - The company aims to establish Actimab-A as a backbone therapy for AML and other myeloid malignancies, leveraging the broad expression of CD33 and the mutation agnostic nature of Ac-225 [3][4] - Actinium anticipates generating preclinical data and initiating additional clinical trials throughout 2025 to further differentiate Actimab-A and demonstrate its potential as a first-in-class radiotherapy for over 100,000 AML patients in the U.S. and other major markets [3][4]

Core Insights - Actinium Pharmaceuticals is advancing its clinical programs for Actimab-A, Iomab-ACT, and Iomab-B, with significant regulatory updates and financial results reported for Q3 2024 [1][2][6] Regulatory and Development Updates - Actinium has aligned with the FDA on a seamless Phase 2/3 trial for Actimab-A combined with CLAG-M for relapsed/refractory acute myeloid leukemia (r/r AML) [1][3] - Actimab-A has been selected for the National Cancer Institute's myeloMATCH precision medicine program targeting AML and myelodysplastic syndromes [1][4] - The FDA has cleared two IND applications for Iomab-ACT, including a commercial CAR-T trial and a sickle cell transplant trial, with proof-of-concept data expected in 2025 [1][4] - Actinium is seeking a U.S. strategic partner for Iomab-B to conduct a Phase 3 trial based on FDA guidance [1][5] Financial Performance - As of September 30, 2024, Actinium reported cash and cash equivalents of approximately $78.6 million, expected to fund operations into 2027 [1][6] - Research and development expenses decreased to $9.8 million in Q3 2024 from $11.6 million in Q3 2023, primarily due to lower CMC expenses [7] - General and administrative expenses increased slightly to $2.8 million in Q3 2024, attributed to higher non-cash stock compensation [8] - The net loss for Q3 2024 was $11.6 million, a decrease from $13.3 million in Q3 2023, due to lower R&D expenses [11]