NEW YORK, Oct. 1, 2018 /PRNewswire/ -- Actinium
Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or
"the Company"), announced today that is has launched its
Iomab-ACT program offering its next-generation, chemo-free,
targeted lymphodepletion technology to the CAR-T industry.
Lymphodepletion is a necessary part of the CAR-T process that is
currently achieved primarily by non-targeted, cytotoxic
chemotherapy like Fludarabine and Cyclophosphamide (Flu/Cy). The
Iomab-ACT program technology has the potential to be a major
improvement over current lymphodepletion regimens due to its
targeted mechanism of action that may improve CAR-T cell expansion,
reduce CAR-T related toxicities and expand patient access to CAR-T
treatment. Actinium recently announced that it has developed
an initial estate of six patents related to the Iomab-ACT program
supported by its internal research and that it has the support of
key physicians from the Froedtert and the Medical College of Wisconsin for the clinical use
of Iomab-ACT in conjunction with CAR-T therapy. Actinium intends to
offer its Iomab-ACT program technology as a universal solution to
developers of CAR-T products from academia and industry.
Dr. Dale Ludwig, Actinium's Chief
Scientific Officer said, "The field of CAR-T has grown and evolved
rapidly, but little innovation has been directed at
lymphodepletion. Our commitment to providing improved conditioning
regimens prior to adoptive cell therapies has allowed us to extend
our focus beyond myeloablation in the case of Iomab-B to
lymphodepletion with the Iomab-ACT program. By targeting CD45
expressing cells with our clinically validated, targeted
radiation-based approach, we are able to target myeloid derived
suppressor cells and regulatory T-cells that can modulate adoptive
cell therapy responses and may improve CAR-T cell expansion and
outcomes. Besides mediating effective lymphodepletion, the
Iomab-ACT construct also targets macrophages, cells that have been
implicated in CAR-T toxicities like cytokine release syndrome (CRS)
and neurotoxicity. Finally, we can potentially reduce a patient's
tumor burden and lymphodeplete without chemotherapy, leaving the
patient in a better physical condition prior to their CAR-T
therapy, and which we believe has the potential to expand patient
access to the promising treatment option of CAR-T
therapy."
Actinium's Iomab-ACT program is an expansion of Actinium's
extensive experience in targeted conditioning focused on
myeloablation for BMT or Bone Marrow Transplant. This
experience has been gained with Iomab-B, its Phase 3 drug candidate
that has been studied in over 500 patients across 10 clinical
trials and a variety of hematological malignancies. The Iomab-ACT
program for lymphodepletion prior to Adoptive Cell Therapies such
as CAR-T is based on the same CD45 targeting ARC or Antibody
Radio-Conjugate used in the Iomab-B program for BMT. However,
the Iomab-ACT program features a lower dose range that is expected
to be as much as 6x-20x less than the dose range used in its
Iomab-B program for myeloablation prior to BMT. As a result,
the Iomab-ACT program is able to offer targeted lymphodepletion via
a single dose and in an outpatient setting. The extensive
safety, efficacy and pharmacokinetic data available from use of the
drug at much higher doses for BMT, as well as other research
studies conducted by the Company, inform and support the intended
dosing schedule and dose range that will likely be required to
achieve effective lymphodepletion in the setting of CAR-T.
The Iomab-ACT program is supported by a portfolio of patent
filings covering composition of matter, formulation, and methods of
use. Actinium formally introduced its Iomab-ACT program on
September 26th, 2018 via a
webcast in conjunction with the Froedtert and Medical College of Wisconsin, a leading CAR-T
and FACT accredited medical institution that is working with the
company on clinical advancement of the program. The webcast is
available for replay on Actinium's website:
https://www.actiniumpharma.com/product-pipeline/iomab-act-program-for-car-t.
Sandesh Seth, Actinium's Chairman
and CEO said, "The Iomab-ACT program went from ideation to launch
in less than one year. This program is another major step in
generating value from our AWE or Antibody Warhead Enabling
technology platform. Note that in less than 6 months from
launch of our AWE partnering program, we were able to secure a
research collaboration with Astellas that resulted in the AWE
program being a profit center for the company. Our expectation is
that, over time, the Iomab-ACT program will also enable the company
to generate value enhancing collaborations. We expect this to
occur as CAR-T developers begin to recognize the potential value of
Iomab-ACT to improve access and outcomes of their products or
product candidates due to its potentially superior safety and
efficacy balance compared to the current chemotherapy-based
regimens which are standard of care. We are very excited to
have launched our Iomab-ACT program as it advances our commitment
to improving patient access and outcomes to adoptive cellular
therapies via our targeted conditioning approach."
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals Inc. is focused on improving patient
access and outcomes to cellular therapies such as bone marrow
transplant (BMT) and CAR-T with its proprietary, chemotherapy free,
targeted conditioning technology. Actinium is the only company with
a multi-disease, multi-target, drug development pipeline focused on
targeted conditioning. Its targeted conditioning technology is
enabled by ARC's or Antibody Radio-Conjugates that combine the
targeting ability of monoclonal antibodies with the cell killing
ability of radioisotopes. Actinium's pipeline of clinical-stage
targeted conditioning ARCs target the antigens CD45 and CD33 for
patients with a broad range of hematologic malignancies including
acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and
multiple myeloma (MM).
Iomab-B, Actinium's lead targeted conditioning product
candidate, is currently enrolling patients in the pivotal Phase 3
SIERRA trial in patients age 55 or older, with active, relapsed or
refractory AML. Iodine-131-apamistamab (Iomab-B), combines the
anti-CD45 monoclonal antibody labeled with iodine-131 for
myeloablation prior to a bone marrow transplant. CD45 is expressed
on leukemia, lymphoma and normal immune cells. Iomab-B has been
studied in over 500 patients in 10 clinical trials in numerous
hematologic diseases. Actinium's Iomab-ACT program is an expansion
of its CD45 program that is intended to be a universal, chemo-free
solution for targeted lymphodepletion prior to CAR-T. Through
targeted lymphodepletion, the Iomab-ACT program is expected to
improve CAR-T cell expansion, reduce CAR-T related toxicities and
expand patient access to CAR-T treatment and potentially other
adoptive cell therapies. Due to its lower payload dose,
lymphodepletion with the Iomab-ACT program can be accomplished
through a single outpatient infusion. Actinium intends to advance
its Iomab-ACT program with CAR-T focused collaborators from
academia and industry.
Actinium's pipeline also includes a potentially best-in-class
CD33 program with its ARC comprised of the anti-CD33 antibody
lintuzumab labeled with the alpha-particle emitter actinium-225.
Its CD33 program is currently being studied in multiple Phase 2 and
Phase 1 clinical trials for targeting conditioning and as a
therapeutic in multiple diseases and indications including AML, MDS
and MM.
Actinium is also developing its proprietary AWE or Antibody
Warhead Enabling technology platform which utilizes radioisotopes
including iodine-131 and the highly differentiated actinium-225
coupled with antibodies to target a variety of antigens that are
expressed in hematological and solid tumor cancers. The AWE
technology enables Actinium's internal pipeline and with the
radioisotope Actinium-225 is being utilized in a collaborative
research partnership with Astellas Pharma, Inc.
Actinium's clinical programs and AWE technology
platform are covered by a portfolio of 77 patents covering
composition of matter, formulations, methods of use and also
methods of manufacturing the radioisotope Actinium-225 in a
cyclotron.
More information is available at www.actiniumpharma.com and our
Twitter feed @ActiniumPharma, www.twitter.com/actiniumpharma.
Forward-Looking Statements for Actinium Pharmaceuticals,
Inc.
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.
Contact:
Actinium Pharmaceuticals, Inc.
Steve O'Loughlin
Principal Financial Officer
soloughlin@actiniumpharma.com
Investor Relations
Rx Communications Group
Paula Schwartz
917-322-2216
pschwartz@rxir.com
Susan A. Noonan
212-966-3650
investorrelations@actiniumpharma.com
View original
content:http://www.prnewswire.com/news-releases/actinium-launches-iomab-act-program-offering-its-targeted-chemo-free-lymphodepletion-technology-as-a-universal-solution-to-car-t-product-developers-300721634.html
SOURCE Actinium Pharmaceuticals, Inc.