- Initial
clinical data expected in the second half of 2025 from this
first-of-its-kind trial to administer a targeted radiotherapy
conditioning agent with a commercial CAR-T therapy
- Iomab-ACT
supported by results of NIH funded trial with MSK showing effective
lymphodepletion of targeted immune cells resulting in negligible
rates of CAR-T toxicities ICANS and CRS and CAR T-cell persistence
with a novel CD19 CAR-T therapy
- Iomab-ACT
has the potential to increase the addressable market for CAR-T
therapies, which generated $4 billion
in sales in 2024, by enabling improved access and better patient
outcomes compared to current chemotherapy conditioning agents
NEW
YORK, May 6, 2025 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a pioneer in the development of targeted radiotherapies,
today announced that the first patient was enrolled on the trial
studying Iomab-ACT targeted conditioning with a commercial CAR-T
therapy at the University of Texas
Southwestern Medical Center (UTSW) (NCT06768905). Initial
clinical data from this trial is expected in the second half of
2025. Actinium is developing Iomab-ACT as a targeted radiotherapy
conditioning agent intended to replace non-targeted
chemotherapeutic conditioning agents such as Fludarabine and
Cyclophosphamide (Flu/Cy) to address serious CAR-T related
toxicities including immune effector cell-associated neurotoxicity
(ICANS) and cytokine release syndrome (CRS), to potentially improve
patient access and outcomes. Currently, there are seven CAR-T
therapies approved for certain leukemias and lymphomas and multiple
myeloma, that over 150,000 patients are diagnosed with annually.
In 2024, the seven approved CAR-T therapies generated over
$4 billion in sales and CAR-T
therapies are forecasted to reach $12
billion in annual sales in 2030.
Dr. Farrukh Awan, Professor of
Medicine, Division of Hematology Oncology at UTSW said, "We are
thrilled to initiate patient enrollment to study Iomab-ACT targeted
radiotherapy conditioning with a commercial CAR-T therapy.
Iomab-ACT is supported by compelling preclinical and clinical data,
and we believe it has immense potential to eliminate the need for
chemotherapy-based conditioning, which is a major barrier for many
patients seeking CAR-T treatment. Despite the positive impact CAR-T
therapy has had on patient outcomes, there is still significant
room for improvement. We are optimistic that Iomab-ACT can
transform CAR-T therapy conditioning if this trial demonstrates it
has the ability to increase patients access and reduce the rates
and severity of ICANS and CRS and also potentially improve patient
outcomes. We are excited to begin treating patients with Iomab-ACT
and eager to present our preliminary findings later this year."
Iomab-ACT targets CD45, a cell surface marker expressed on
immune cells relevant to CAR-T therapy including lymphocytes and is
the only clinical stage conditioning agent targeting CD45.
Preclinical data demonstrated that Iomab-ACT can selectively target
immune cells implicated in CAR-T toxicities, while sparing bone
marrow stem cells, red blood cells and platelets. Preclinical and
clinical data also showed that Iomab-ACT produces transient
lymphodepletion that aligns with the CAR-T treatment process. This
data supported the first clinical trial of Iomab-ACT with a novel
CD19 CAR-T therapy in collaboration with Memorial Sloan Kettering
Cancer Center (MSK) in patients heavily pretreated with relapsed
and refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) or
Diffuse Large B-cell Lymphoma (DLBCL). In this study, no patients
(0/4) developed ICANS of any grade, and minimal CRS. Iomab-ACT also
demonstrated transient depletion of peripheral blood lymphocytes
and monocytes, persistence of CAR T-cells up to 8 weeks and minimal
non-hematologic toxicities. These positive findings supported the
continued advancement of Iomab-ACT and the initiation of the
commercial CAR-T trial at UTSW.
Sandesh Seth, Actinium's Chairman
and CEO, stated, "This is a pivotal moment for our Iomab-ACT CD45
targeted radiotherapy conditioning program. Iomab-ACT is a highly
differentiated conditioning agent that has produced promising
initial clinical results where multiple targeted conditioning
approaches including monoclonal antibodies and antibody drug
conjugates directed against a variety of targets have not achieved
clinical success to date. Based on the promising initial outcomes
from the pilot study of Iomab-ACT with a novel CD19 CAR-T, we
are incredibly excited by the potential of this commercial CAR-T
trial and future development path. With initial clinical data
expected beginning in the second half of this year, we are making
strong progress to achieving our goal of establishing Iomab-ACT as
a universal targeted conditioning regimen for CAR-T and other
cellular therapies."
Targeted Radiotherapy CAR-T Conditioning Opportunity
A multi-billion-dollar market opportunity exists for better
conditioning in other areas of cellular therapy, such as CAR-T.
Currently, there are seven CAR T-cell therapies targeting CD19 for
lymphoma and leukemia and BCMA for multiple myeloma that are
approved by the FDA with total sales of over $4.0 billion in 2024. The pipeline of CAR-T
therapies in development has rapidly expanded, with the addressable
patient population expected to nearly double and reach
approximately 93,000 patients in the U.S. by 2030 based on the
current pipeline of cellular therapies. The addressable market for
Iomab-ACT is in line with the patient population for cellular
therapies that is approximately150,000 patients annually across the
indications in which CAR-T therapies are approved, as all patients
receive conditioning of some type. We believe a potential
blockbuster revenue opportunity exists for Iomab-ACT assuming it
can provide clinical benefits related to adverse events related to
CAR-T, longer duration of response or improved survival
outcomes.
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. ATNM-400 is
Actinium's novel non-PSMA targeting Ac-225 radiotherapy for
prostate cancer, which is supported by preclinical data
demonstrating higher efficacy than Pluvicto (PSMA-617-Lutetium-177)
and potent efficacy in Pluvicto resistant prostate cancer models.
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.