Actinium Pharmaceuticals Launches Actinium-225 Focused Strategic Initiative to Leverage Proprietary Cyclotron Based Manufacturing Technology to Address Growing Market Demand
- Actinium Pharmaceuticals, Inc. launches a strategic initiative for Actinium-225 production using a proprietary cyclotron-based method.
- The company's technology is backed by 5 U.S. patents, 49 international patents, and extensive technical knowledge.
- Actinium-225 produced by this method is highly pure, cost-effective, and offers higher yields compared to current methods.
- The initiative includes a multi-million-dollar investment to scale up production and meet the increasing demand for Actinium-225.
- Actinium plans to collaborate with partners globally to enhance the value of its patents and capabilities.
- None.
Insights
The announcement by Actinium Pharmaceuticals regarding their cyclotron-produced Actinium-225 (Ac-225) represents a significant advancement in the production of medical isotopes used in targeted radiotherapies. The proprietary method's ability to produce Ac-225 with radiochemical and radionuclidic purity comparable to the current gold-standard, coupled with the potential for significantly lower costs at commercial scale, could disrupt the current supply dynamics within the targeted radiotherapy market.
From a research perspective, the scalability of Actinium's method is of particular interest. The ability to generate up to 100 mCi of Ac-225 per production cycle could meet the increasing demand for clinical-grade Ac-225, which is currently limited. Furthermore, the cost reduction factor, potentially 10 to 20 times lower than existing material, may facilitate broader adoption and application of Ac-225 in clinical settings. This could lead to an expansion of treatment options for patients and potentially improve therapeutic outcomes for various cancers.
Actinium's strategic initiative to scale its cyclotron-based Ac-225 production has implications for the company's market position. By committing to a multi-million-dollar investment and seeking global collaborations, Actinium aims to capitalize on the growing demand for Ac-225, which is driven by its application in Antibody-Radio Conjugates (ARCs) and other targeted radiotherapies.
The market for targeted radiotherapies is expanding, with a focus on precision medicine and personalized treatments. Actinium's patents and technical know-how in this area could provide them with a competitive edge and possibly create new revenue streams through partnerships and supply agreements. The move may also be seen as a strategic effort to reduce dependency on the United States Department of Energy (DOE) and other entities for the supply of Ac-225, which has been traditionally derived from thorium-229 decay. As the company progresses towards late-stage trials and commercialization, the ability to self-supply Ac-225 could offer greater control over production costs and product availability.
Investors may view Actinium Pharmaceuticals' investment into Ac-225 production technology as a forward-looking strategy to strengthen its pipeline of targeted radiotherapies. The proprietary manufacturing technology's potential for lower-cost production at commercial scale could enhance the company's gross margins on ARCs and other related therapies. This, in turn, might lead to improved financial performance in the long term.
It is crucial, however, to monitor the execution of this strategic initiative, as the capital expenditure involved is substantial. The return on investment will depend on the company's ability to scale production efficiently and secure a significant share of the market amidst competition and alternative production methods. Additionally, the company's valuation could be impacted by the market's perception of its capability to maintain a consistent supply of high-purity Ac-225 and the success of its late-stage trials.
- Actinium's cyclotron produced Actinium-225 material has demonstrated radiochemical and radionuclidic purity identical to current gold-standard methods and has the potential to be significantly lower cost at commercial scale than currently available production methods
- Proprietary manufacturing technology supported by 5 issued
U.S. patents, 49 issued international patents and significant technical know-how - Actinium to commit to multi-million-dollar investment and pursue collaborations on a global basis to scale its technology for commercial purposes to support internal programs and address growing demand for Actinium-225
- End-to-end solution including processing and recycling of Radium-226 starting material
- Production of up to 100 mCi of Ac-225 per production cycle
- Utilizes a medium energy cyclotron
- Expected cost 10 – 20 times lower than currently available material
- Radiochemical purity >
99% - Radioisotopic purity
99.8% with no long-lived contaminants
Sandesh Seth, Actinium's Chairman and CEO, said, "Significant efforts and investments have been made by Actinium in developing our proprietary method and related intellectual property and know-how. With our Ac-225 based Actimab-A program advancing to late-stage trials under our CRADA with the NCI and the rapidly increasing number of Ac-225 based programs in development, the time is now to fully realize the potential of our production method. We are excited to launch this initiative and are committed to making further strategic investments to bring our method to commercial scale while engaging with potential collaborators and partners globally to maximize the value of our patents and capabilities, as well as to ensure supply for our increasing Ac-225 based product development efforts and address the growing clinical demand."
Currently, the majority of Ac-225 is supplied by the United States Department of Energy (DOE) who derives Ac-225 from the natural decay of thorium-229 from so-called "thorium-cows". Actinium Pharmaceuticals, Inc. has maintained supply agreements with the DOE since 2009. The DOE has stated that it is exploring the generation of new thorium cows and production via a cyclotron. In addition, multiple government and non-governmental entities globally are focused on Ac-225 production using various methods and have represented that clinical grade Ac-225 could be available over the next several years. However, at this time, the majority of material available is research grade and there is limited availability of clinical grade Ac-225 outside of the material supplied by the DOE. The relative scarcity of Ac-225 has led to rapidly escalating procurement costs in recent years.
Mr. Seth, added, "Having already produced highly pure material at scale, we believe our method can be implemented rapidly thereby accelerating supply of highly sought after clinical grade Ac-225. From a technical perspective, our proprietary method addresses the limited availability of source material needed to generate Ac-225 via a cyclotron by purifying and recycling from a variety of different sources. This enables us to leverage the large infrastructure of cyclotrons that already exists globally or the ability to establish new facilities for significantly less cost and faster than reactor or linear accelerator-based production methods. In addition, we have developed several additional technical benefits enabling scalability and manufacturing efficiencies. Based on our experience to date, we expect to be able to produce material with high radiochemical purity and at yields not possible with thorium-cow based methods. This has the potential to further establish Actinium as a leader in alpha-particle therapies and remain at the forefront of innovation while addressing a significant and rapidly growing addressable patient population."
For more information, please visit Actinium Pharmaceuticals, Inc. website https://www.actiniumpharma.com/actinium-225-technology or email sseth-bd@actiniumpharma.com
About Actinium Pharmaceuticals, Inc.
Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA & MAA (EU)), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium holds more than 220 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.
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