Actinium Pharmaceuticals, Inc. Expands R&D Capabilities with New Research Facility to Enhance Development of Next Generation An

Actinium Pharmaceuticals, Inc. Expands R&D Capabilities with New Research Facility to Enhance Development of Next Generation An

  Actinium Pharmaceuticals, Inc. Expands R&D Capabilities with New Research
    Facility to Enhance Development of Next Generation Antibody Radiation
              Conjugates Leveraging Its Proprietary AWE Platform

PR Newswire

NEW YORK, Oct. 14, 2020

NEW YORK, Oct. 14, 2020 /PRNewswire/ -- Actinium Pharmaceuticals, Inc.  (NYSE
AMERICAN: ATNM) ("Actinium" or the "Company") today announced the launch of
its new research and development lab facility in New York City.  This new
research facility expands Actinium's internal R&D capabilities and will be
focused on developing novel Antibody Radiation Conjugate (ARC) candidates, ARC
therapeutic combination strategies, and supporting AWE platform research
collaborations. Actinium's R&D efforts will employ a multidisciplinary
approach leveraging its team's expertise and experience in cancer cell
biology, radiochemistry, radiation sciences, immunology and oncology drug
development.  The proprietary AWE technology platform, protected by over one
hundred and twenty-five patents, is the foundation for Actinium's R&D and
exploits multiple different radioisotope payloads including the potent
alpha-emitter, Actinium-225.  

(PRNewsfoto/Actinium Pharmaceuticals, Inc.)

This new research facility will function under the guidance of Dr. Dale
Ludwig, Ph.D. the Company's Chief Scientific & Technology Officer, who has
over twenty-five years of oncology discovery research and development
experience, including supporting the development and launch of Erbitux®,
Cyramza^TM, Portrazza®, and Lartruvo^TM as well as the clinical advancement of
at least 10 additional therapeutic antibodies and Antibody Drug Conjugates
while at Eli Lilly and, previously, ImClone Systems Inc.  The research
facility will be managed and staffed by Ph.D. level scientists who will
contribute their respective expertise in areas of drug discovery, radiation
chemistry, and translational research to advance novel ARC programs and
investigations into combination therapeutic strategies.

"Our new research facility will allow us to significantly accelerate our
preclinical and clinical development of novel ARC programs and investigate
mechanistic ARC therapeutic combinations, which utilize our expertise in
radioimmunobiology, our AWE Technology Platform capabilities, and know-how,"
said Dale Ludwig.  "The establishment of an internal research facility was a
priority for Actinium's long-term strategy, as we look to deliver on our
pipeline development activities, as well as expand our portfolio of promising
product candidates through partnerships and collaborations.  Furthermore, in
both preclinical and clinical studies, we have shown mechanistic synergies
when our ARCs are combined with novel and approved therapeutic agents in
treating cancer.  The addition of this R&D facility will enable more rapid
investigation of novel mechanistic drug combinations that can be effectively
translated into clinical testing."

Over the last eighteen months, Actinium has advanced its research and
discovery activities in three key areas —the development of next generation
ARCs, therapeutic combinations with ARCs, and improved targeted conditioning
treatments for adoptive cell therapies such as CAR-T.  As presented at the
2018 AACR Annual Meeting, cell death improved as much as thirty-fold and cell
death occurred in treatment resistant cell lines when daratumumab, an
anti-CD38 directed antibody approved for the treatment of multiple myeloma
(MM), was labeled with Ac-225 using Actinium's AWE Technology Platform.  The
power and potency of Actinium's AWE Technology Platform is also demonstrated
in an ongoing Actimab-A combination study with CLAG-M in difficult to treat
R/R AML patients. Patients treated with a sub-therapeutic dose of Actimab-A
combined with CLAG-M had improved response rates by over 60% versus CLAG-M
treatment alone.  In September, preclinical data supporting Iomab-ACT as a
viable and effective method for achieving targeted lymphodepletion prior to an
adoptive cell therapy such as CAR-T was published in the journal Oncotarget
(https://www.oncotarget.com/archive/v11/i39/).  Leveraging the new laboratory
facility, Actinium intends to further its research activities in these areas
which will aid in developing next generation targeted conditioning agents and
exploring therapeutic combinations with ARCs and of proven oncology and
immunooncology agents.

The Company intends to focus on generating novel ARCs, building on its
existing intellectual property, evaluating assets for in-licensing to
complement existing clinical pipeline, as well as securing collaborations and
partnerships with other biopharmaceutical companies.  By adding research and
development capabilities to its clinical development and clinical supply chain
capabilities, Actinium will be positioned to enable the rapid translation of
radioimmunotherapies into the clinic.  The Company's AWE platform intellectual
property covers various methods of use for ARCs in multiple diseases,
including indication, dose and scheduling, radionuclide warhead, and
therapeutic combinations.  Actinium's AWE technology patent portfolio includes
29 patent families comprised of over 130 issued or pending global patent
applications, of which 10 are issued and 31 pending in the United States.

Sandesh Seth, Chairman and Chief Executive Officer of Actinium, said, "The
opening of our R&D facility is an important milestone that will support both
internal and collaborative efforts at advancing the field of ARCs.  Our
growing and highly talented R&D team is focused on harnessing the power of our
AWE Technology Platform to enhance our clinical pipeline and drive current and
additional collaborations.  Having these capabilities in house will allow us
to more efficiently execute on our multi-disciplinary research efforts and
continue to innovate and extend our leadership position in the growing field
of ARCs."

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
developing ARCs or Antibody Radiation-Conjugates, which combine the targeting
ability of antibodies with the cell killing ability of radiation.  Actinium's
lead application for our ARCs is targeted conditioning, which is intended to
selectively deplete a patient's disease or cancer cells and certain immune
cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell
Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells
with minimal toxicities.  With our ARC approach, we seek to improve patient
outcomes and access to these potentially curative treatments by eliminating or
reducing the non-targeted chemotherapy that is used for conditioning in
standard practice currently.  Our lead product candidate, I-131 apamistamab
(Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in
Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT
conditioning.  The SIERRA trial is over fifty percent enrolled and positive
single-agent, feasibility and safety data has been highlighted at ASH, TCT,
ASCO and SOHO annual meetings.  I-131 apamistamab will also be studied as a
targeted conditioning agent in a Phase 1/2 anti-HIV stem cell gene therapy
with UC Davis and is expected to be studied with a CAR-T therapy in 2020.  In
addition, we are developing a multi-disease, multi-target pipeline of
clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted
conditioning and as a therapeutic either in combination with other therapeutic
modalities or as a single agent for patients with a broad range of hematologic
malignancies including acute myeloid leukemia, myelodysplastic syndrome and
multiple myeloma.  Ongoing combination trials include our CD33 alpha ARC,
Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2
targeted therapy venetoclax.  Underpinning our clinical programs is our
proprietary AWE (Antibody Warhead Enabling) technology platform.  This is
where our intellectual property portfolio of over 100 patents, know-how,
collective research and expertise in the field are being leveraged to
construct and study novel ARCs and ARC combinations to bolster our pipeline
for strategic purposes.  Our AWE technology platform is currently being
utilized in a collaborative research partnership with Astellas Pharma, Inc.
Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc. 

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.

Contacts:

Investors:
Clayton Robertson
Actinium Pharmaceuticals, Inc.
crobertson@actiniumpharma.com

Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 535-7743

 

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SOURCE Actinium Pharmaceuticals, Inc.

Website: http://www.actiniumpharma.com/

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