Poster to present additional data
showcasing ability of Actinium’s AWE Technology to yield a potential
biobetter of daratumumab, a blockbuster CD38 targeted therapy for
multiple myeloma
Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company")
announced today that its abstract has been accepted for a poster
presentation at the 2018 American Association for Cancer Research (AACR)
Annual Meeting being held April 14-18, 2018 in Chicago, Illinois. The
abstract showcases the potential of Actinium’s AWE Technology Platform,
specifically, the ability of actinium-225 to enhance the in vivo
efficacy of daratumumab, a CD38 targeting therapy that is marketed by
Johnson & Johnson as Darzalex®.
Per
the abstract submission highlighted below, the Ac-225 labelled
daratumumab at an equimolar concentration demonstrated superior
antitumor activity to naked daratumumab in a highly predictive DAUDI
model and provided a survival benefit. Additional details will be
available at the time of the Annual Meeting. The Company had earlier
presented initial in vitro data at ASH which studied the effect of
Actinium-225 labeled daratumumab on DAUDI, 28BM and 28PE cell lines at
the 48, 72 and 96 hour time points as well as U226, a cell line that
does not express CD38. The results showed that when daratumumab is
labeled with Actinium-225, cell death was increased as much as ten-fold,
approaching one-hundred percent cell death in certain cell lines and at
certain time points, and in all three cell lines tested the
Actinium-225 labeled daratumumab had higher cell death compared to naked
daratumumab. In addition, immunogenicity was preserved with most or
all of daratumumab’s CD38 targeting ability maintained, high rates of
radioisotope labeling of the antibody from 82-85% was demonstrated, as
was high rates of stability from 73-87% at various temperatures
forty-eight hours post labeling.
Details on the poster are as follows:
Abstract Number: 760
Session Category: Experimental and Molecular Therapeutics
Sandesh
Seth, Actinium’s Chairman and Chief Executive Officer said, “We are
excited to build upon the already exciting data from our AWE Program and
are looking forward to presenting new data from our continued efforts.
The data we will present will exemplify Actinium’s expanding R&D
capabilities and the potential of our AWE technology platform, which are
now being spearheaded by our new Chief Scientific Officer, Dr. Dale
Ludwig. This is the first AACR that Actinium has presented data at and
we look forward to a growing and impactful presence as we are committed
to continuing to leverage our AWE technology and extending our
capabilities both on behalf of our internal efforts but also for
partners”
About Our Actinium Warhead Enabling Technology Platform
The
Actinium Warhead Enabling (AWE) Technology Platform enables a highly
potent and selective form of targeted therapy that combines the powerful
alpha-emitting radioisotope actinium-225 with targeting agents, which
are designed to seek out cancer cells in the body that express
particular markers. Actinium-225 emits significant alpha radiation
making it a potent treatment modality against targeted cancer cells
while limiting damage to healthy tissues as its radiation travels
extremely short distances in the body. When labeled to targeting agents,
actinium-225 can be delivered directly to cancer cells where the high
linear energy transfer resulting from the emission of alpha particles
results in irreparable DNA double stranded breaks and ultimately cancer
cell death. Despite this superior cell killing power, actinium-225 when
delivered in a targeted manner is sparing of the surrounding
environment in the body due to the short path length of its
alpha-particle radiation and can result in a superior safety profile.
Actinium Pharmaceuticals owns or has licensed the rights to several
issued and pending patents that pertain to its AWE Technology Platform
including technology to manufacture Actinium-225 in a cyclotron. In
addition, the Company obtains actinium-225 from various sources such as
the U.S. Department of Energy at Oak Ridge National Laboratories and has
developed considerable know-how, expertise and validated processes
related to production of Actinium Radio-Conjugates (ARC’s), management
of the supply chain and dealing with various regulatory bodies. The AWE
Technology Platform can be utilized to potentially improve the
cell-killing power of targeting agents such as antibodies, peptides, Fab
fragments, nanobodies etc. via labeling with Actinium-225. In addition
to increased efficacy, these Actinium-225 enhanced targeting agents can
offer optimized dosing or administration and in the case of approved
targeting agents provide an opportunity to extend intellectual property
protection by the creation of biobetters or improved versions of the
approved agent. The Company’s Actinium Warhead Enabling (AWE) Program
can be accessed by biopharmaceutical companies that are interested in
creating biobetters through the utilization of the AWE Platform
Technology. To learn more about the AWE Technology Platform or the AWE
Program please contact Keisha Thomas, Ph.D., Corporate Development at
kthomas@actiniumpharma.com.
About Actinium Pharmaceuticals, Inc.
Actinium
Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company
focused on developing and commercializing targeted therapies for
potentially superior myeloablation and conditioning of the bone marrow
prior to a bone marrow transplant and for the targeting and killing of
cancer cells. Our targeted therapies have demonstrated the potential to
result in significantly improved access to bone marrow transplant with
better outcomes, namely increased marrow engraftment and survival. Our
targeted therapies are ARC’s or Actinium Radio-Conjugates that combine
the targeting ability of monoclonal antibodies with the cell killing
ability of radioisotopes. Three of our four ARC drug candidates are
based on our AWE or Actinium Warhead Enabling Technology Platform that
utilizes the isotope Actinium-225 (Ac-225) which emits alpha particles.
We are currently conducting clinical trials for our four product
candidates; Iomab-B, Actimab-A Actimab-M and Actimab-MDS, as well as
performing research on other potential drug candidates utilizing our
proprietary AWE Technology Platform. Our most advanced product
candidate, Iomab-B, an ARC developed by the Fred Hutchinson Cancer
Research Center, is comprised of an anti-CD45 monoclonal antibody
labeled with iodine-131. We are currently conducting a pivotal Phase 3
trial of Iomab-B for myeloablation and conditioning of the bone marrow
prior to a bone marrow transplant for patients with relapsed or
refractory acute myeloid leukemia (AML) age 55 and older. A bone marrow
transplant is a potentially curative treatment for patients with AML and
other blood cancers including leukemias, lymphomas and multiple myeloma
as well as certain blood disorders. Iomab-B has been tested in several
of these other cancers with over five hundred patients treated in
several Phase 1 and 2 trials with promising results. Upon successful
completion of our Phase 3 clinical trial for Iomab-B we intend to submit
this candidate for marketing approval in the U.S. and European Union
where it has been designated as an Orphan Drug. We are also developing a
potentially best in class CD33 program using an ARC comprised of the
anti-CD33 monoclonal antibody lintuzumab labeled with the alpha-particle
emitter Ac-225. Our most CD33 program candidate, Actimab-A, is
currently in a Phase 2 clinical trial for patients advanced over the age
of 60 who are newly diagnosed with AML and ineligible for standard
induction chemotherapy. Actimab-A also has Orphan Drug designation in
the US and EU. Actimab-M, our second CD33 targeting ARC, is being
studied in a Phase 1 trial for patients with refractory multiple
myeloma. Actinium is also planning a Phase 2 trial for Actimab-MDS, our
third CD33 program candidate, as a conditioning regimen prior to a bone
marrow transplant for patients with MDS that have a p53 genetic
mutation. Our AWE or Actinium Warhead Enabling Technology Platform,
originally developed in conjunction with Memorial Sloan Kettering Cancer
Center, is focused on leveraging Actinium’s know how and intellectual
property to create additional ARC drug candidates by labeling Ac-225 to
targeting moieties that we will either progress in clinical trials
ourselves or out-license.
More information is available at www.actiniumpharma.com
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