- Dr. Farrukh Awan, Professor of
Medicine, Division of Hematology Oncology at University of Texas Southwestern and Principal
Investigator for the trial to join Actinium management for
webinar
- Expansion of Iomab-ACT program with commercial CAR-T supported
by ongoing MSKCC clinical trial with success implying a potential
billion-dollar market opportunity in lymphodepletion
- Webinar to be held on Monday, May
20th at 8:00 AM
ET
NEW
YORK, May 7, 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 it will host a KOL call on Monday,
May 20, 2024, at 8:00 AM ET to
provide updates and highlight its recently announced clinical trial
to study Iomab-ACT with a leading FDA approved CAR-T cell therapy
at the University of Texas Southwestern
(UTSW). Iomab-ACT is an ARC that targets CD45, a marker expressed
on blood cancer cells and immune cells that is intended to enable
conditioning prior to cell and gene therapies such as CAR T-cell
therapy and replace the non-targeted chemotherapy that is currently
used for conditioning. There are six CAR-T cell therapies approved
to treat patients with leukemias, lymphomas and multiple myeloma
that collectively reached sales in 2023 exceeding $3.5 billion.
Dr. Farrukh Awan specializes in
the treatment of patients with leukemia and lymphoma including
CAR-T therapy and bone marrow transplantation. Dr. Awan will serve
as principal investigator for this study that will be led by
UTSW.
To date, Iomab-ACT has been studied in a clinical trial with an
investigational CD19 targeting CAR-T cell therapy developed by
Memorial Sloan Kettering Cancer Center (MSKCC) under a National
Institutes of Health funded grant. The trial at UTSW will be the
first trial to study Iomab-ACT or any targeted radiotherapy
conditioning agent with an FDA approved CAR-T therapy.
Registration for the KOL webinar can be found here or on the
investor relations page of Actinium's website here.
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 and minimal Cytokine Release
Syndrome (CRS). ICANS is observed in 25% or more of pts w/ R/R
B-ALL and DLBCL treated with various currently approved CAR T-cell
products. 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 must
receive some type of conditioning 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 with selective lymphodepletion 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
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.
