- Potential blockbuster opportunity for next-generation targeted
radiotherapy conditioning with CAR T-cell therapy a
multi-billion market with six FDA approved therapies totaling sales
over $3.5 billion in 2023 and cell
and gene therapies forecasted to reach over ninety-thousand
patients annually by 2030
- Iomab-ACT is the first targeted radiotherapy agent intended to
be used to condition patients for cell and gene therapies to
replace the need for non-targeted chemotherapy
- Iomab-ACT clinical data to date shows CAR T-cell persistence
and ability to deplete targeted immune cells including lymphocytes
resulting in negligible rates of CAR-T toxicities ICANS and
CRS
NEW
YORK, March 26, 2024 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the
Company), a leader in the development of Antibody Radiation
Conjugates (ARCs) and other targeted radiotherapies, today
announced that the University of Texas
Southwestern Medical Center (UT Southwestern) will lead a
clinical trial studying Actinium's Iomab-ACT, a targeted
radiotherapy conditioning agent prior to patients receiving an FDA
approved commercial CAR T-cell therapy. UT Southwestern will start
recruiting patients following FDA's review and clearance of the
study. CAR T-cell therapy utilizes patients' own immune cells
called T-cells, which are engineered to include a chimeric antigen
receptor and then reinfused into the patient to recognize and
destroy cancer cells. Currently, there are six CAR-T therapies
approved to treat patients with leukemias, lymphomas and multiple
myeloma that collectively reached sales in 2023 exceeding
$3.5 billion.
Actinium developed Iomab-ACT with the goal of replacing the
chemotherapy conditioning regimens currently used prior to cell and
gene therapies. Early clinical data with Iomab-ACT conditioning
prior to CAR-T demonstrates its ability to produce targeted
lymphodepletion along with negligible incidences of immune effector
cell-associated neurotoxicity syndrome (ICANS) or cytokine release
syndrome (CRS), which are the major toxicities observed with the
current chemotherapy based conditioning regimens, which are
suboptimal and can limit patients from CAR-T access and may result
in poor outcomes.
Sandesh Seth, Actinium's Chairman
and CEO, stated, "This is a pivotal moment for our Iomab-ACT
program that presents the opportunity to produce potential practice
changing clinical data. Cellular therapies such as CAR-T and gene
therapies represent a multi-billion market opportunity with an
expectation of nearly doubling to reach approximately 93,000
patients annually in the U.S. alone by 2030. We believe Iomab-ACT
can be a universal conditioning regimen based on its potential to
reduce CAR-T related toxicities such as ICANS and CRS, as evidenced
by our early clinical work with a novel CD19 CAR T-cell therapy and
may improve patient access and outcomes by eliminating the need for
the non-targeted chemotherapy-based conditioning that are currently
required prior to CAR-T therapies. This trial is a clear
demonstration of Actinium's commitment to being at the forefront of
applying targeted radiotherapy to innovative applications and novel
indications."
Dr. Avinash Desai, Actinium's
Chief Medical Officer, added, "Cellular therapies like CAR-T have
transformed outcomes for tens of thousands of patients but
clinicians continue to be frustrated with the need to use
chemotherapy for conditioning. We are excited to be collaborating
with the team at UT Southwestern on this first ever trial to study
Iomab-ACT with a commercial CAR-T. Given the extensive data with
CAR-T therapies, results from this study can
allow us to show the impact of Iomab-ACT on reducing CAR-T related
toxicities such as ICANS and CRS and improving efficacy including
persistence of CAR-T cells, rates of response, and other efficacy
outcomes. Based on the initial results from our clinical trial with
Memorial Sloan Kettering's CD19 CAR-T therapy, we are looking
forward to initiating this study and delivering clinical proof of
concept data with a commercial CAR-T."
Ongoing Iomab-ACT Phase 1 CAR-T Conditioning Results
Actinium presented results from its ongoing phase 1 trial using
Iomab-ACT as conditioning prior to CD19 CAR-T therapy for patients
with relapsed or refractory B-cell Acute Lymphoblastic Leukemia
(B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) at the Tandem
Meetings I Transplantation & Cellular Therapy Meetings of
ASTCT and CIBMTR the combined annual meetings of the American
Society for Transplantation and Cellular Therapy (ASTCT) and
the Center for International Blood & Marrow Transplant Research
(CIBMTR) in February 2024.
Importantly, no patients (0/4) developed immune effector
cell-associated neurotoxicity syndrome (ICANS) of any grade, a
major safety measure of the study, as ICANS is observed in 25% or
more of pts w/ R/R B-ALL and DLBCL treated with various CAR T-cell
products and minimal CRS. Iomab-ACT demonstrated transient
depletion of peripheral blood lymphocytes and monocytes.
Persistence of CAR T-cells up to 8 weeks and minimal
non-hematologic toxicities have been observed to date.
Targeted Radiotherapy Conditioning Opportunity
The opportunity exists for better conditioning in other areas of
cellular therapy, such as CAR-T as well as gene therapies. The
pipeline of CAR-T and gene therapies 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 CAR-T market size in
terms of revenue is estimated to grow at a CAGR of approximately
11% over the next 5 plus years. Currently, there are six CAR T-cell
therapies approved by the FDA that are used to treat patients with
lymphomas, leukemia, and multiple myeloma, which collectively had
total sales of over $3.5 billion in
2023. The addressable market for Iomab-ACT is in line with the
patient population for cell and gene therapies as all patients
receive conditioning of some type prior to these treatments. We
will continue to develop Iomab-ACT, our next-generation
conditioning program for rapidly growing cell and gene therapies
based on early promising results, ultimately with the value
proposition of improving overall access and outcomes for patients
who need cellular or gene therapies. A potential blockbuster
revenue opportunity exists for Iomab-ACT assuming it can provide
one or more clinical benefits related to lower CRS, less ICANS,
longer duration of response or a higher overall success rate of
cellular therapy due to benefits of targeted conditioning.
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.