- 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
NEW YORK,
March 11,
2024 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a leader in the development of Antibody-Radio Conjugates
(ARCs) and other targeted radiotherapies, today announced that it
has launched a strategic initiative focused on the manufacture of
the highly sought after medical isotope Actinium-225 (Ac-225)
leveraging its propriety cyclotron-based method. Actinium-225 is a
potent alpha-particle emitter that has high linear energy transfer
capable of killing targeted cancer cells via double-strand breaks
in DNA for which there is no known resistance or repair mechanism,
making it a highly sought after isotope for targeted
radiotherapies. Actinium's intellectual property portfolio relating
to its cyclotron-based production method includes 5 issued U.S.
patents and 49 issued international patents as well as significant
technical know-how. Ac-225 produced using Actinium's method is
highly pure and identical to the current gold-standard
manufacturing method using a Thorium-229 generator but has the
potential to be lower-cost at commercial scale and is a higher
yielding approach. Specifically, Actinium's Ac-225 based technology
and production methods are grounded in several U.S. and
International patents that cover the following areas:
- 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-launches-actinium-225-focused-strategic-initiative-to-leverage-proprietary-cyclotron-based-manufacturing-technology-to-address-growing-market-demand-302084842.html
SOURCE Actinium Pharmaceuticals, Inc.
