Source: Actinium Pharmaceuticals, Inc.
- Dr. Ludwig brings over
20 years of leadership and management expertise from Eli Lilly and
Company and Imclone Systems, Inc. in oncology antibody therapeutics
discovery and
development where he supported the development and launch
of Erbitux®, CyramzaTM,
Portrazza®, and LartruvoTM, and the clinical advancement of 10 additional therapeutic
antibodie
-
Actinium’s recently announced Actinium Warhead Enabling Technology
Platform is focused
on the generation of antibody radio-conjugates and
biobetters designed to expand Actinium’s
pipeline and facilitate
collaborations
Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"),
announced today that Dr. Dale L. Ludwig has been appointed Chief
Scientific Officer. Dr. Ludwig joins Actinium from Eli Lilly and
Company, and prior to that Imclone Systems Inc., serving most recently
as Chief Scientific Officer/Vice President, Oncology Discovery Research –
Biologics Technology. Dr. Ludwig will be responsible for leading the
Company’s initiatives on its Actinium Warhead Enabling (AWE) Technology
Platform and the AWE Program that is focused on the utilization of the
payload actinium-225 (Ac225) in conjunction with targeting
agents to create Antibody Radio-Conjugates or ARC’s and bio-betters with
the goal of expanding Actinium’s clinical pipeline and facilitating
collaborations. In addition, Dr. Ludwig will also lead preclinical
program development and support clinical development programs via
translational research efforts.
“I am
incredibly excited and honored to be joining Actinium Pharmaceuticals,”
said Dr. Dale Ludwig. “Having worked successfully in the discovery and
development of therapeutic antibodies for oncology most of my
professional career, I recognized the potential therapeutic value of
Actinium’s ARC or Antibody Radio-Conjugate approach utilizing an
actinium-225 isotope payload. Actinium has assembled a team that is
committed to the advancement of this potentially transformational
technology with its Ac225 based clinical programs and to
further develop the AWE Technology Platform. I am thrilled to be a part
of the Actinium team and to contribute to building a pioneering company
that creates value through the development of novel ARC based
therapeutics that improve patient outcomes.”
Dr.
Ludwig was a member of the Oncology Research Senior Leadership Team at
Eli Lilly and Company. Dr. Ludwig brings to Actinium proven leadership
and research management expertise through his work at Eli Lilly and
prior to that at Imclone Systems Inc. where he supported the development
and successful launch of several biologic oncology drugs including
Erbitux®, CyramzaTM, Portrazza®, and LartruvoTM as
well as the clinical advancement of 10 additional therapeutic
antibodies. Most recently, Dr. Ludwig served Chief Scientific
Officer/Vice President of Oncology Discovery Research - Biologics
Technology at Eli Lilly. In this role he was responsible for directing
antibody discovery and development for oncology biologics and
contributed to key strategic and project advancement efforts. In
addition, Dr. Ludwig also brings significant alliance management
experience having directed the empowered antibody drug discovery
programs that included collaborations with Immunogen and Zymeworks.
Sandesh
Seth, Actinium’s Chairman and CEO said, “Dr. Ludwig has enjoyed a
successful career at Eli Lilly and Imclone where he developed and built
his expertise in biologic drug discovery and development as well as his
leadership skills, making him the ideal addition to the Actinium team. I
am incredibly excited to have Dale on board, particularly at this
pivotal juncture in Actinium’s progression and am confident that under
his leadership the Company will have significant accomplishments related
to its research efforts and further development of the AWE Technology
Platform. Clearly our industry leading CD33 Program is a testimony to
the power of the AWE technology platform and the ability of ARC’s to be
effective where antibody-arming approaches using toxins have less
potential, as evidenced by our initiatives with Actimab-M and
Actimab-MDS. Dr. Ludwig is well suited to drive future efforts to
utilize the power of the AWE technology for both the Company and
collaborators. It is exciting to continue to strengthen the leadership
team at Actinium. With each successive hire our capabilities become
amplified which enables us to better drive toward the expected clinical
milestones related to the Iomab-B, Actimab-A, Actimab-M and Actimab-MDS
programs as well as our AWE platform, and to unlock the value inherent
in Actinium.”
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 has developed considerable know-how, expertise and
validated processes related to production of Antibody Radio-Conjugates
or 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 Antibody 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 (Ac225) that 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 actinium-225. Our most advanced 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 Ac225 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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