- Actinium to highlight 3 separate
multi-billion-dollar market opportunities for Actimab-A and
Iomab-ACT in myeloid malignancies, solid tumors and cell & gene
therapy conditioning
- Clinical proof of concept data
expected in 2H:2025 from Actimab-A combination with blockbuster
immunotherapies KEYTRUDA® and OPDIVO® in
solid tumor indications
- Actimab-A expanded into
frontline AML in triplet combination with Venetoclax and ASTX-727,
Taiho Oncology's hypomethylating agent, under NCI CRADA with
initial clinical data expected by year-end 2025
- Planned pivotal Phase 2/3 trial
for Actimab-A + CLAG-M in relapsed/refractory AML patients further
supported by recent publication of results in peer-reviewed journal
Leukemia reporting 18.4 median overall survival
- Iomab-ACT commercial CAR-T
trial to initiate patient enrollment with clinical proof of concept
data expected in 2H:2025; Iomab-ACT sickle cell disease trial
expected to initiate in 1H:2025
- Call
Scheduled for 8:00 AM ET on Tuesday, March
25, 2025
NEW
YORK, March 19, 2025 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a pioneer in the development of targeted radiotherapies,
today announced that it will host a KOL call that will feature Dr.
Ehab Atallah, Professor of Medicine
at the Medical College of Wisconsin and
principal investigator of the Actimab-A + CLAG-M combination trial
in patients with relapsed/refractory acute myeloid leukemia (r/r
AML). Dr. Atallah will discuss Actimab-A clinical results to date
including recently published long-term survival outcomes and the
planned pivotal Phase 2/3 clinical trial in r/r AML and trials to
be conducted under Actinium's cooperative research and development
agreement (CRADA) with the National Cancer Institute (NCI). In
addition, Actinium will provide a pipeline update to highlight 3
separate potential multi-billion-dollar blockbuster market
opportunities for its targeted radiotherapies including the
following:
- Actimab-A as a mutation agnostic, backbone therapy for myeloid
malignancies including AML and myelodysplastic syndromes (MDS)
across multiple treatment settings
- 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)
- Iomab-ACT as a universal targeted conditioning agent to
increase patients access to cell & gene therapies and improve
patient outcomes
To register for the KOL Call & Pipeline Update please use
the following link:
https://lifescievents.com/event/actinium-2/
Sandesh Seth, Actinium's Chairman
and CEO, said, "We have made significant progress across our
pipeline in the first quarter of 2025 achieving several important
milestones. We are excited to highlight the large
multi-billion-dollar market opportunities for Actimab-A in myeloid
malignancies and now solid tumors, as well as cell and gene therapy
conditioning with Iomab-ACT. With cash runway into 2027, we are in
an excellent position to advance our programs, and we are excited
to deliver validating data in the second half of 2025."
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 in 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.
