- Newly
issued U.S. patent augments Actinium's existing composition of
matter patent coverage over Iomab-B and Iomab-ACT targeted
radiotherapy conditioning programs
- Pertains to
the use of Iomab-ACT with genetically engineered hematopoietic stem
cells for treating non-malignant diseases including sickle cell
disease, severe combined immunodeficiency disease, β-thalassemia
and Fanconi's anemia
NEW
YORK, Aug. 1, 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 the issuance of U.S. Patent No. 11,912,780 titled,
"Anti-CD45-Based Conditioning Methods and Uses Thereof in
Conjunction with Gene-Edited Cell Based Therapies" by the United
States Patent and Trademark Office (USPTO). This patent extends
into 2040 and covers methods using Iomab-ACT for conditioning
patients prior to the administration of gene-edited hematopoietic
stem cell (HSC) therapy to treat non-malignant disorders, such as
sickle cell disease, severe combined immunodeficiency disease
(SCID), β-thalassemia and Fanconi's anemia. 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.
Sandesh Seth, Actinium's Chairman
and CEO, stated, "The field of gene-edited stem cell therapies is
rapidly evolving, with the potential to transform or even cure
debilitating diseases. Recognizing this emerging field, we are
excited to further strengthen our intellectual property portfolio,
demonstrating our commitment to innovation in targeted
radiotherapy. We aim to establish Iomab-ACT as a universal,
non-chemotherapy targeted conditioning regimen for use across cell
and gene therapies for both malignant and non-malignant
indications. Current conditioning regimens use high doses of
cytotoxic chemotherapies such as busulfan and others that are
associated with infertility and other toxicities posing barriers
for patients seeking gene therapy for non-cancerous diseases.
Collectively, the indications covered under this patent afflict
over one hundred thousand patients each year, and we are committed
to improving access and outcomes for these patients via Iomab-ACT
as is evidenced by our recent clinical collaborations with leading
academic institutions to determine the potential of Iomab-ACT as a
conditioning regimen prior to a cellular therapy".
Actinium's intellectual property portfolio also includes a
family of issued composition of matter patents covering Iomab-B and
Iomab-ACT, extending into 2037. The term of newly issued U.S.
Patent No. 11,912,780 extends patent protection over Iomab-ACT
aspects until 2040. The Company is pursuing further patent coverage
for Iomab-ACT in the U.S. and internationally.
Iomab-ACT is currently being studied in a clinical trial at
Memorial Sloan Kettering Cancer Center with a CD19 CAR-T therapy in
patients with relapsed or refractory B-cell Acute Lymphoblastic
Leukemia (r/r B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) that
is supported by grant funding from the National Institutes of
Health (NIH). Initial proof of concept data showed that Iomab-ACT
produced transient depletion of peripheral blood lymphocytes and
monocytes and that CAR-T cells persisted up to eight weeks post
infusion. Minimal non-hematologic toxicities have been observed to
date. Specifically, there were no (0/4) cases of 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 patients with r/r B-ALL and DLBCL treated with various
CAR-T cell products. Iomab-ACT is being studied in a Phase 1 trial
as conditioning prior to treatment with a commercial CAR-T therapy
in collaboration with the University of
Texas Southwestern (UTSW) as well as a Phase 1 trial to
condition patients with sickle cell disease prior to a stem cell
transplant in collaboration with Columbia
University that is expected to inform a gene therapy
conditioning trial in patients with sickle cell disease. IND
applications have been cleared by the FDA for both the commercial
CAR-T and sickle cell disease Phase 1 trials and patient enrollment
is expected to commence.
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 (Cooperative Research and Development
Agreement (CRADA) with the National Cancer Institute), 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.