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

Rhea-AI Summary

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.

Positive

• Secured reliable Actinium-225 supply for clinical development pipeline
• Advancing to pivotal Phase 2/3 trial for Actimab-A in AML
• Expanding therapeutic applications to solid tumors through combinations with established drugs

Negative

• None.

Insights

Biopharmaceutical Supply Chain Analyst

Actinium's strategic supply agreement with Eckert & Ziegler addresses a critical operational challenge in radiopharmaceutical development by securing reliable access to Actinium-225 (Ac-225), which the article specifically notes faces a global shortage. For a smaller biotech with $45M market cap, this agreement fundamentally derisks their development pathway by stabilizing the supply chain for their core therapeutic platform.

The timing coincides with Actinium accelerating their clinical program with Actimab-A advancing into a pivotal Phase 2/3 trial for relapsed/refractory AML and expansion into solid tumors through combinations with established checkpoint inhibitors like KEYTRUDA and OPDIVO. Without guaranteed access to high-quality Ac-225, these clinical initiatives would face significant execution risk.

The partnership with an established radioisotope supplier like Eckert & Ziegler particularly benefits Actinium given the technical complexities of alpha-emitting isotopes - these require specialized handling, have relatively short half-lives, and demand precise quality control. While financial terms remain undisclosed, this agreement represents a foundational operational milestone rather than merely a routine supply contract.

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: https://www.actiniumpharma.com/

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:
investorrelations@actiniumpharma.com 

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SOURCE Actinium Pharmaceuticals, Inc.

FAQ

What is the purpose of Actinium Pharmaceuticals' (ATNM) new supply agreement with Eckert & Ziegler?

The agreement ensures ATNM's access to high-quality Actinium-225 for developing Actimab-A and other candidates in U.S. and international clinical trials.

What clinical trials is ATNM conducting with Actimab-A in 2025?

ATNM is conducting a pivotal Phase 2/3 trial for relapsed/refractory AML and a Phase 1 frontline trial with NCI, plus solid tumor trials combining with KEYTRUDA and OPDIVO.

Which cancer types is ATNM targeting with Actimab-A in solid tumor trials?

ATNM is targeting head and neck squamous carcinoma and non-small cell lung cancer in combination with checkpoint inhibitors.

How does Actinium-225 work in ATNM's cancer treatments?

Ac-225 releases powerful alpha particles with high energy and low penetration, precisely targeting tumor cells and micrometastases while minimizing damage to healthy tissue.