A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 and ASTX727 + Venetoclax in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)

This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and/or effective in treating patients with AML and MDS.

Start Date16 Sep 2025

Sponsor / Collaborator

National Cancer Institute

NCT06802523

/ Not yet recruitingPhase 1IIT

A Phase I Study of Lintuzumab-Ac-225 in Combination With Venetoclax and ASTX-727 in Adults With Newly Diagnosed AML

This phase I trial tests the safety, side effects, and best dose of lintuzumab-Ac225 in combination with venetoclax and ASTX-727, and how well they work in treating patients with newly diagnosed acute myeloid leukemia (AML). Lintuzumab-Ac225 is a monoclonal antibody, called lintuzumab, linked to a radioactive agent called actinium Ac 225. Lintuzumab attaches to CD33 positive cancer cells in a targeted way and delivers actinium Ac 225 to kill them. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. ASTX-727 is a combination of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Giving lintuzumab-Ac225 in combination with venetoclax and ASTX-727 may be safe and tolerable in treating patients with newly diagnosed AML and may improve the chance of going into remission and staying in remission for a longer period of time.

Start Date30 Apr 2025

Sponsor / Collaborator

National Cancer Institute

NCT06802146

/ RecruitingEarly Phase 1IIT

A Multi-Site Break Through Cancer Pilot Study Testing the Feasibility and Safety of Therapeutic Intervention for Patients with High-risk Clonal Cytopenia of Undetermined Significance (CCUS)

This research is being done to find out more about the potential risks and benefits of early treatment in participants with high risk Clonal Cytopenia of Unknown Significance (CCUS). This study will give eligible CCUS participants the option of either being observed or taking an oral drug as treatment.
The names of the study drug involved in this study is:
-Decitabine/cedazuridine (DEC/CED) (a nucleoside metabolic inhibitor and cytidine deaminase inhibitor).

Start Date07 Feb 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

100 Clinical Results associated with Decitabine/Cedazuridine

100 Translational Medicine associated with Decitabine/Cedazuridine

100 Patents (Medical) associated with Decitabine/Cedazuridine

Literatures (Medical) associated with Decitabine/Cedazuridine

01 Nov 2024·BRITISH JOURNAL OF HAEMATOLOGY

Oral decitabine/cedazuridine versus intravenous decitabine for acute myeloid leukaemia: A randomised, crossover, registration, pharmacokinetics study

Article

Author: Sano, Yuri ; Novák, Jan ; Illes, Arpad ; Santini, Valeria ; Keating, Mary‐Margaret ; Fracchiolla, Nicola Stefano ; Metzelder, Stephan K. ; Lübbert, Michael ; Lunghi, Monia ; Rodríguez‐Macías, Gabriela ; Platzbecker, Uwe ; Oganesian, Aram ; Arnan, Montserrat ; Mayer, Jiří ; Krauter, Jürgen ; del Castillo, Teresa Bernal ; Koristek, Zdenek ; Geissler, Klaus ; Keer, Harold

Summary:

This study compared decitabine exposure when administered IV (DEC‐IV) at a dose of 20 mg/m2 for 5‐days with orally administered decitabine with cedazuridine (DEC‐C), as well as the clinical efficacy and safety of DEC‐C in patients with acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy. In all, 89 patients were randomised 1:1 to DEC‐IV or oral DEC‐C (days 1–5 in a 28‐day treatment cycle), followed by 5 days of the other formulation in the next treatment cycle. All patients received oral DEC‐C for subsequent treatment cycles until treatment discontinuation. Equivalent systemic decitabine exposures were demonstrated (5‐day area under the curve ratio between the two decitabine formulations of 99.64 [90% confidence interval 91.23%, 108.80%]). Demethylation rates also were similar (≤1.1% difference). Median overall survival (OS), clinical response and safety profile with oral DEC‐C were consistent with those previously observed with DEC‐IV. Next‐generation sequencing was performed to identify molecular abnormalities that impact OS and TP53 mutations were associated with a poor outcome. These findings support the use of oral DEC‐C in patients with AML.

01 Sep 2024·Clinical Lymphoma Myeloma & Leukemia

Oral Decitabine/Cedazuridine Is an Effective Ambulatory Therapy for Patients With Myelofibrosis Refractory to JAK2 Inhibitor Therapy

Article

Author: Dueck, Amylou ; Ginzburg, Yelena ; Handa, Shivani ; Mascarenhas, John O ; Sivakumar, Ganesh ; Tremblay, Douglas ; Kremyanskaya, Marina ; Hoffman, Ronald ; Srisuwananukorn, Andrew

BACKGROUND:

Outcomes are dismal for patients with myelofibrosis (MF) who are no longer responsive to JAK2 inhibitors (JAKi) and/or have increasing blast cell numbers. Although prior reports have suggested the benefits of intravenous decitabine (DAC) combined with ruxolitinib for patients with Myeloproliferative Neoplasm (MPN) accelerated/blast phase (AP/BP), decitabine-cedazuridine (DEC-C), an oral fixed-dose combination providing equivalent pharmacokinetic exposure, has not been evaluated in MF.

METHODS:

We conducted a retrospective analysis of 14 patients with high-risk MF refractory to ruxolitinib or MPN-AP (10-19% blasts) treated with DEC-C +/- JAKi at Mount Sinai Hospital from 2021 to 2024.

RESULTS:

The cohort was elderly (median age,76 years) and almost uniformly possessed high risk mutations with 13 of the 14 patients progressing on JAKi therapy. With a median follow-up of 9.4 months, the median overall survival (OS) was 29 months for the entire cohort. Median OS was 10.8 months for MPN-AP and was not reached for ruxolitinib refractory MF patients. All patients (n = 9) receiving > 4 cycles of DEC-C had clinical benefit exemplified by a reduction in blast cell numbers, spleen size, and lack of progression to MPN-BP (78%). Furthermore, 3/14 patients proceeded to allogeneic stem cell transplant. Myelosuppression was a common adverse event which was managed by reducing the number of days of administration of DEC-C from 5 to 3 per cycle.

CONCLUSIONS:

This report demonstrates the feasibility, tolerability, and clinical benefit of an exclusively ambulatory regimen for high-risk, elderly patients with advanced MF which warrants further evaluation in a prospective clinical trial.

01 Apr 2024·The Lancet. Haematology

Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study

Article

Author: Garcia-Manero, Guillermo ; Kadia, Tapan ; Short, Nicholas ; Pierce, Sherry ; Alvarado, Yesid ; Bataller, Alex ; Masarova, Lucia ; Jain, Nitin ; Islam, Rabiul ; Konopleva, Marina ; Kornblau, Steven ; Ravandi, Farhad ; Montalban-Bravo, Guillermo ; Bazinet, Alexandre ; Maiti, Abhishek ; Issa, Ghayas ; Abuasab, Tareq ; DiNardo, Courtney D ; Daver, Naval ; Kantarjian, Hagop ; Yilmaz, Musa ; Huang, Xuelin ; Jabbour, Elias ; Montalbano, Kathryn ; Rausch, Caitlin R

BACKGROUND:

Hypomethylating agents combined with venetoclax are effective regimens in patients with acute myeloid leukaemia who are ineligible for intensive chemotherapy. Decitabine and cedazuridine (ASTX727) is an oral formulation of decitabine that achieves equivalent area-under-curve exposure to intravenous decitabine. We performed a single centre phase 2 study to evaluate the efficacy and safety of ASTX727 plus venetoclax.

METHODS:

This study enrolled patients with newly diagnosed (frontline treatment group) acute myeloid leukaemia who were ineligible for intensive chemotherapy (aged ≥75 years, an Eastern Cooperative Oncology Group [ECOG] performance status of 2-3, or major comorbidities) or relapsed or refractory acute myeloid leukaemia. Being aged 18 years or older and having an ECOG performance status of 2 or less were requirements for the relapsed or refractory disease treatment cohort, without any limits in the number of previous lines of therapy. Treatment consisted of ASTX727 (cedazuridine 100 mg and decitabine 35 mg) orally for 5 days and venetoclax 400 mg orally for 21-28 days in 28-day cycles. The primary outcome was overall response rate of ASTX727 plus venetoclax. Living patients who have not completed cycle one were not evaluable for response. Safety was analysed in all patients who started treatment. This study was registered on ClinicalTrials.gov (NCT04746235) and is ongoing. The data cutoff date for this analysis was Sept 22, 2023.

FINDINGS:

Between March 16, 2021, and Sept 18, 2023, 62 patients were enrolled (49 frontline and 13 relapsed or refractory) with a median age of 78 years (IQR 73-82). 36 (58%) were male; 53 (85%) were White, 4 (6%) Black, 2 (3%) Asian and 3 (5%) other or did not answer. 48 (77%) of 62 patients were European LeukemiaNet 2022 adverse risk, 24 (39%) had antecedent myelodysplastic syndromes, 12 (19%) had previously failed a hypomethylating agent, ten (16%) had therapy-related acute myeloid leukaemia, and 11 (18%) had TP53 mutations. The median follow-up time was 18·3 months (IQR 8·8-23·3). The overall response rate was 30 (64%) of 47 patients (95% CI 49-77) in frontline cohort and six (46%) of 13 patients (19-75) in relapsed or refractory cohort. The most common grade 3 or worse treatment-emergent adverse events were febrile neutropenia in 11 (18%) of 62 patients, pneumonia in eight (13%), respiratory failure in five (8%), bacteraemia in four (6%), and sepsis in four (6%). Three deaths occurred in patients in remission (one sepsis, one gastrointestinal haemorrhage, and one respiratory failure) and were potentially treatment related.

INTERPRETATION:

ASTX727 plus venetoclax is an active fully oral regimen and safe in most older or unfit patients with acute myeloid leukaemia. Our findings should be confirmed in larger multicentric studies.

FUNDING:

MD Anderson Cancer Center Support Grant, Myelodysplastic Syndrome/Acute Myeloid Leukaemia Moon Shot, Leukemia SPORE, Taiho Oncology, and Astex Pharmaceuticals.

News (Medical) associated with Decitabine/Cedazuridine

27 Mar 2025

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Actinium Pharmaceuticals Provides Business Update After Presentation at Trump Mar-A-Lago Club Announcing Novel Non-PSMA Prostate Cancer Radiotherapy ATNM-400 and Outlining Revitalized Clinical Pipeline with 2025 Corporate Objectives

- 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 conditioning - Actinium's targeted radiotherapy programs expanded to four multi-billion-dollar market opportunities NEW YORK, March 27, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today provided a business update detailing recent achievements and anticipated milestones from its revitalized and expanding clinical pipeline. The update featured the unveiling of ATNM-400, Actinium's new Actinium-225 (Ac-225) solid tumor program, which is a novel, non-PSMA targeting, first-in-class radiotherapy for prostate cancer. Initial preclinical data from ATNM-400 will be presented at AACR on April 27, 2025. In addition, Actinium highlighted its 2025 manufacturing infrastructure activity, including its Actinium-225 cyclotron manufacturing technology, to support its expanding clinical pipeline. Finally, Actinium highlighted several clinical trials that are expected to generate clinical data in the second half of 2025 including its Actimab-A frontline AML trial under its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), data from trials in the Actimab-A solid tumor program which combines Actimab-A with PD-1 checkpoint inhibitors KEYTRUDA® and OPDIVO® in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) and Iomab-ACT commercial CAR-T and sickle cell disease (SCD) trials. This update follows Actinium's company presentation at Trump Mar-a-Lago Club on March 26th and an Actimab-A KOL investor call on March 25th, which can be accessed for replay here. Sandesh Seth, Actinium's Chairman and CEO, said, "We are resurgent and expect 2025 will be an impactful year for Actinium as we execute to demonstrate the inherent value of our truly innovative and first of their kind clinical programs that focus on patients with high unmet needs. We are thrilled to introduce ATNM-400 and we look forward to presenting our promising preclinical results at AACR in April. We believe a significant opportunity exists in prostate cancer for ATNM-400, particularly for patients progressing or not well served by the PSMA targeting radiotherapy Pluvicto given its novel target and the potent cell killing ability of the Ac-225 isotope payload. In conjunction with advancing our clinical programs, several of which are expected to generate clinical data this year, we are building out manufacturing infrastructure in 2025 to support these programs which are expected to enter advanced development in 2026. Our strong balance sheet with cash runway expected to last into mid-2027 allows us to focus on unlocking the value inherent in our pipeline which has four distinct blockbuster opportunities with Actimab-A in hematology and solid tumors, Iomab-ACT in cell and gene therapy conditioning and now ATNM-400 in prostate cancer." Actinium's 2025 achievements to date including the following: Unveiled ATNM-400, a first-in-class, novel non-PSMA targeting Actinium-225 radiotherapy for prostate cancer with initial preclinical data to be presented at AACR on April 27, 2025 Initiated Actimab-A frontline AML triplet trial under NCI CRADA that will study Actimab-A as a backbone in combination with Venetoclax and ASTX-727, an oral hypomethylating agent developed by Taiho oncology, Inc., an Otsuka Holdings company Results of Actimab-A + CLAG-M combination trial published in the peer-reviewed journal Leukemia highlighting high rates of MRD- and improved overall survival in patients with r/r AML Initiated Actimab-A solid tumor program to combine Actimab-A with PD-1 checkpoint inhibitors KEYTRUDA and OPDIVO in head-to-head trials in head and neck squamous cell carcinoma and non-small cell lung cancer Entered into sponsored research agreements with Memorial Sloan Kettering Cancer Center to further elucidate Actimab-A's mutation agnostic mechanism of action and potential as a backbone therapy in myeloid malignancies Executed a supply agreement with Exckert & Ziegler for Actinium-225 Radioisotope to support comprehensive development activities for both U.S. and international clinical trials Abstracts accepted for presentation at the American Association for Cancer Research Annual Meeting highlighting Actimab-A's mutation agnostic profile in AML Actinium's pipeline revitalization has resulted in expanded market opportunities for its first-in-class targeted radiotherapies in myeloid malignancies, solid tumors and cell and gene therapy conditioning. Actinium seeks to address four distinct blockbuster opportunities with ATNM-400, Actimab-A and Iomab-ACT. Actinium outlined its 2025 business objectives for its revitalized and expanding clinical pipeline as follows: Pipeline Expansion into Prostate Cancer with ATNM-400, a first-in-class, non-PSMA targeting Ac-225 radiotherapy Present abstract at AACR highlighting Actinium-225 targeted radiotherapy for novel radiotherapy cancer target Establish In-house Radiopharmaceutical Manufacturing & Production Advance build-out of manufacturing facility Explore strategic partnerships leveraging proprietary Actinium-225 cyclotron manufacturing technology Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across multiple treatment settings Initiate Phase 2/3 trial in combination with CLAG-M in relapsed or refractory AML and seek potential partners or collaborators Generate initial clinical data in frontline AML in first trial under CRADA with NCI Initiate additional clinical trials in myeloid malignancies Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs) Generate clinical proof of concept data in head and neck squamous cell carcinoma and non-small cell lung cancer Explore additional solid tumor indications for future trials Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes Present initial data from commercial CAR-T trial at University of Texas Southwestern Generate clinical data in first non-malignant indication from sickle cell disease allogeneic stem cell transplant trial at Columbia University About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. ATNM-400 is Actinium's novel non-PSMA targeting Ac-225 radiotherapy for prostate cancer, which is supported by preclinical data and is being advanced to clinical trials. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 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Clinical Study

26 Mar 2025

·www.prnewswire.com

Actinium Pharmaceuticals to Present Business Update at Trump Mar-A-Lago Club Today

- 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 26, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, announced it will be presenting a business update today at Trump Mar-a-Lago Club, Florida. This presentation follows an Investor KOL Call and Company Update hosted by Actinium on Tuesday, March 25th highlighting its revitalized clinical programs and expanded market opportunities. Actinium's Investor KOL Call and Company Update can be accessed for replay here. Sandesh Seth, Actinium's Chairman and CEO, said, "We are honored to have this opportunity to present Actinium Pharmaceuticals and highlight the significant progress we have made in the last several months at the Mar-a-Lago Club. We have great enthusiasm for our revamped clinical programs and expect to achieve significant milestones in 2025. If successful, we will have the opportunity to address multiple potential blockbuster market opportunities with Actimab-A in myeloid malignancies and solid tumors and with Iomab-ACT for cell and gene therapy conditioning." Actinium has outlined its expanded market opportunities and expected 2025 milestones for each of its clinical programs as well as its R&D and radiopharmaceutical manufacturing capabilities as follows: Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across multiple treatment settings Initiate Phase 2/3 trial in combination with CLAG-M in relapsed or refractory AML and seek potential partners or collaborators Generate initial clinical data in frontline AML in first trial under CRADA with NCI Initiate additional clinical trials in myeloid malignancies Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs) Generate clinical proof of concept data in head and neck squamous cell carcinoma and non-small cell lung cancer Explore additional solid tumor indications for future trials Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes Present initial data from commercial CAR-T trial at University of Texas Southwestern Generate clinical data in first non-malignant indication from sickle cell disease allogeneic stem cell transplant trial at Columbia University Pipeline Expansion Leveraging Targeted Radiotherapy R&D Capabilities Present abstract at AACR highlighting Actinium-225 targeted radiotherapy for novel radiotherapy cancer target Establish In-house Radiopharmaceutical Manufacturing & Production Advance build-out of manufacturing facility Explore strategic partnerships leveraging proprietary Actinium-225 cyclotron manufacturing technology Mr. Seth continued, "In addition to the multitude of milestones that lie ahead for our clinical programs, we are excited to highlight our expanding capabilities. As a pioneer in targeted radiotherapy, we are leveraging our robust know-how and intellectual property to develop new pipeline programs to address indications with high unmet needs. In addition, we are investing in our infrastructure and are thrilled to be moving ahead with the build-out of our manufacturing facility starting next quarter in anticipation of future clinical success. Finally, we look forward to fully leveraging our proprietary Actinium-225 cyclotron manufacturing technology to meet our projected demand given our expanding Actinium-225 programs as well as facilitate strategic partnerships. With our strong balance sheet providing runway into mid-2027, our team is focused and committed on execution and value creation." About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 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Clinical Study

24 Mar 2025

·www.prnewswire.com

Actinium Pharmaceuticals Announces Supply Agreement with Eckert & Ziegler for Ac-225 Radioisotope to Support Comprehensive Development Activities

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 candidates for both U.S. and international clinical trials. Targeted radiotherapies using Ac-225 have shown great promise in the treatment of cancer. The radioisotope releases powerful alpha particles with high energy and low penetration depth, enabling precise targeting of tumor cells, including hard-to-reach micrometastases, while minimizing effects on surrounding healthy tissue. Actimab-A is an Ac-225 based radiotherapy agent, directed against CD33, a receptor overexpressed in patients with acute myeloid leukemia (AML) and other myeloid indications. Sandesh Seth, Chairman and CEO at Actium Pharmaceuticals, Inc. commented: "We believe that targeted radiation therapy with Actinium-225 is one of the most promising approaches for treating patients with myeloid malignancies and solid tumors. As we have highlighted recently, we are advancing our lead targeted radiotherapy Actimab-A into a pivotal Phase 2/3 trial for patients with relapsed or refractory acute myeloid leukemia and in the frontline setting in a Phase 1 trial under our CRADA with the NCI. Additionally, we have launched our Actimab-A solid tumor program to combine with PD-1 checkpoint inhibitors KEYTRUDA and OPDIVO for patients with head and neck squamous carcinoma and non-small cell lung cancer in multiple trials. As a pioneer in the development of target radiotherapies, we have aggressive plans to expand our clinical pipeline to address indications with high unmet needs. With this supply agreement with Eckert & Ziegler, we will have access to reliable and constant supply of Ac-225 to advance our product development both in the U.S. as well as internationally." "We are happy to contribute to the continuous expansion of indications for Actinium-225, which is significantly being advanced by Actinium Pharmaceuticals," explained Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. "The progress we have made in our Ac-225 project over the past year marks only the start of our program to address the global shortage of this vital radionuclide." Eckert & Ziegler reliably supplies high-quality Gallium-68, Lutetium-177, Yttrium-90, and Actinium-225 to leading pharmaceutical companies, and research institutions worldwide. With expertise in radioisotope production and global logistics, the company is committed to continuously support the development and delivery of innovative radiopharmaceuticals. About Eckert & Ziegler Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse. Contributing to saving lives. About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: [email protected] SOURCE Actinium Pharmaceuticals, Inc. 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Radiation Therapy

100 Deals associated with Decitabine/Cedazuridine

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KEGG	Wiki	ATC	Drug Bank
-	Decitabine/Cedazuridine	L01XY	DB15694

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Acute Myeloid Leukemia	European Union	Otsuka Pharmaceutical Netherlands B.V.	15 Sep 2023
Acute Myeloid Leukemia	Iceland	Otsuka Pharmaceutical Netherlands B.V.	15 Sep 2023
Acute Myeloid Leukemia	Liechtenstein	Otsuka Pharmaceutical Netherlands B.V.	15 Sep 2023
Acute Myeloid Leukemia	Norway	Otsuka Pharmaceutical Netherlands B.V.	15 Sep 2023
Chronic Myelomonocytic Leukemia	Australia	Otsuka Australia Pharmaceutical Pty Ltd.	29 Oct 2020
Myelodysplastic Syndromes	United States	Taiho Oncology, Inc.	07 Jul 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
IDH2 mutation Acute Myeloblastic Leukemia	Phase 2	-	National Cancer Institute	01 Apr 2025
Myelodysplastic-Myeloproliferative Diseases	Phase 2	United States	The University of Texas MD Anderson Cancer Center	31 Jan 2025
Myeloproliferative Disorders	Phase 2	United States	The University of Texas MD Anderson Cancer Center	31 Jan 2025
Acute Lymphoblastic Leukemia	Phase 2	United States	Astex Pharmaceuticals, Inc.	01 Jul 2024
Acute Lymphoblastic Leukemia	Phase 2	United States	The University of Texas MD Anderson Cancer Center	01 Jul 2024
Hematologic Neoplasms	Phase 2	United States	The University of Texas MD Anderson Cancer Center	01 Jul 2024
Hematologic Neoplasms	Phase 2	United States	Astex Pharmaceuticals, Inc.	01 Jul 2024
Hematopoietic stem cell transplantation	Phase 2	United States	Astex Pharmaceuticals, Inc.	01 Jul 2024
Hematopoietic stem cell transplantation	Phase 2	United States	The University of Texas MD Anderson Cancer Center	01 Jul 2024
Leukemia	Phase 2	United States	The University of Texas MD Anderson Cancer Center	01 Jul 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05010772 (4277, ASH2024)	Phase 1	Acute Myeloid Leukemia complex cytogenetics \| antecedent MDS/MPN \| therapy-related AML ... View more	31	ASTX727 alone	yznvzohmgd(ruxoanxjid) = lbvcacfisl hgdexvvarn (dxszwbrqrx ) View more	Positive	09 Dec 2024
				ASTX727 plus venetoclax	yznvzohmgd(ruxoanxjid) = ueigqndron hgdexvvarn (dxszwbrqrx ) View more
NCT04746235 (2896, ASH2024)	Phase 2	Acute Myeloid Leukemia TP53mutation \| FLT3-ITD \| N/KRASmutation	60	ASTX727 35/100 mg + Venetoclax 400 mg	myabscddin(xnnhrvqgxu) = mfdefhwfbi xyyxwaavey (sadjquawrs ) View more	Positive	08 Dec 2024
NCT05360160 (ASH2024) Manual	Phase 1/2	Acute Myeloid Leukemia NPM1 Mutation \| KMT2A Rearrangement \| NUP98 Rearrangement	26	Revumenib (SNDX-5613) with Decitabine/Cedazuridine (ASTX727) and Venetoclax (SAVE)	odhalqofqu(ldrzgeloqz) = okbirwzakl wwgpznqsav (jzpocdrxqv ) View more	Positive	07 Dec 2024
NCT05835011 (CTgov)	Phase 2	Myelodysplastic Syndromes	2	Decitabine/Cedazuridine+Magrolimab	reguodtcmf = tdupwepmhf rishmlrtkt (knrljaapyx, ptyenntjgj - ryqvzagine) View more	-	02 Oct 2024
NCT02103478 \| NCT03306264 (ASCERTAIN, EHA2024) Manual	Phase 2/3	Myelodysplastic Syndromes	180	DEC-CDEC-C (ASTX727)	uaxtmbzrvr(ofzuxiwite) = ywswerpbcb xobryrbrpl (nxdgovciox ) View more	Positive	14 May 2024
				DEC-Ccitabine	uaxtmbzrvr(ofzuxiwite) = riwtegupav xobryrbrpl (nxdgovciox )
MYDAS-T MDS05 \| ES-3000 (EHA2024)	Phase 1/2	Myelodysplastic Syndromes	8	ES-3000 60mg TID	fkgyopibom(ksgzylaznp) = One patient progressed and subsequently died of infective complications (colitis) attributable to progressive disease in cycle 2 pkuymdgbyp (iamjamhsml ) View more	-	14 May 2024
EHA2024	Not Applicable	Chronic Myelomonocytic Leukemia	50	Azacitidine	ikirmzhvxe(ujhhsjzwra) = zjzhmkynad nrwvgjdxif (iniafkemec ) View more	-	14 May 2024
				Decitabine-cedazuridine	ikirmzhvxe(ujhhsjzwra) = jzxwwnkmpd nrwvgjdxif (iniafkemec ) View more
NCT04746235 (Pubmed) Manual	Phase 2	Acute Myeloid Leukemia	62	ASTX727 (cevenetoclax 100 mg and decitabine 35 mg) plus venetoclax 400 mg	iqkhkcdoaj(exzilambii) = tnqycbyfxg tpbpqsiguk (ncvoxmbzkm ) View more	Positive	01 Apr 2024
				ASTX727 + venetoclax 400 mgvenetoclax 400 mg (newly diagnosed acute myeloid leukaemia)	iqkhkcdoaj(exzilambii) = ttdzbzjciy tpbpqsiguk (ncvoxmbzkm, 49 - 77)
NCT03306264 (ASCERTAIN, Pubmed 1 \| Pubmed 2 \| Lancet Haematol) Manual	Phase 3	Chronic Myelomonocytic Leukemia \| Myelodysplastic Syndromes	133	ASTX727	snkoryhbkl(zqvwntnpdo) = rfydxtgbyt afcpzlcpoz (wagidiqeiv, 92·66 - 105·60) View more	Positive	01 Jan 2024
				decitabine	jrndlndrih(sodxduidow) = xagrygmjid fplbuqrdcw (delvscbgfd )
NCT04746235 (ASH2023)	Phase 2	Acute Myeloid Leukemia	52	ASTX727 (Decitabine/Cedazuridine) plus Venetoclax	veipeawfto(vozhkokdbv) = citlgjfooq xvagknycni (pcxoyisdts ) View more	-	11 Dec 2023

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