ABII » Topics » Pluripotent Adult Stem Cells

This excerpt taken from the ABII 10-K filed Mar 12, 2010.

Pluripotent Adult Stem Cells

In September 2006, we entered into a license with the University of Maryland under which we exclusively licensed the worldwide intellectual property rights to the CD34+ non-adherent adult bone marrow stem cell technology. This technology may present an opportunity to reverse the effects of neurodegenerative diseases such as macular degeneration, Alzheimer’s and Parkinson’s diseases, and multiple sclerosis, as well as to rehabilitate non-CNS diseased organs such as the pancreas for autologous production of insulin in diabetic patients.

These excerpts taken from the ABII 10-K filed Mar 6, 2009.

Pluripotent Adult Stem Cells

In September of 2006, we entered into a license with the University of Maryland under which we exclusively licensed the worldwide intellectual property rights to the CD34+ non-adherent adult bone marrow stem cell technology. This technology may present an opportunity to reverse the effects of neurodegenerative

 

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diseases such as macular degeneration, Alzheimer’s and Parkinson’s diseases, and multiple sclerosis, as well as to rehabilitate non-CNS diseased organs such as the pancreas for autologous production of insulin in diabetic patients.

Pluripotent Adult Stem Cells

FACE="Times New Roman" SIZE="2">In September of 2006, we entered into a license with the University of Maryland under which we exclusively licensed the worldwide intellectual property rights to the CD34+ non-adherent adult bone marrow stem cell
technology. This technology may present an opportunity to reverse the effects of neurodegenerative

 


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diseases such as macular degeneration, Alzheimer’s and Parkinson’s diseases, and multiple sclerosis, as well as to rehabilitate non-CNS diseased
organs such as the pancreas for autologous production of insulin in diabetic patients.

Cancer Drug Discovery Targeting the Tumor Suppressor p53

In July 2007, we entered into a license agreement with the Buck Institute for Age Research under which we exclusively licensed the
worldwide intellectual property rights for technologies designed to generate novel therapeutics and identify new drug discovery targets. There are no up-front or milestone payments required by us under the license agreement. If products are
successfully developed incorporating any of the licensed technologies, we will pay the Buck Institute royalties based on a percentage of net sales. The term of the agreement will continue until the last patent claiming a licensed product under the
agreement expires. However, the license agreement may be terminated earlier by either party upon the other party’s failure to timely cure a material breach under the agreement or upon the other party’s bankruptcy or insolvency.


Through this license agreement, we own the rights to a proprietary discovery platform designed to discover new chemical entities that remediate the
signaling activities of the tumor suppressor p53 in p53-dysfunctional cancer cells. Loss of p53 activity is associated with one-half of all human tumors, often rendering these cancer cells resistant to conventional therapies. The licensed
technologies have made the discovery of reactivators of appropriate p53 signaling behavior possible. Inherent in the design of the technologies is a strategy to develop therapeutics that selectively stimulate programmed cell death in
p53-dysfunctional cancer cells and that would leave healthy cells expressing normal p53 unaffected.

The therapies developed in this
program will target a specific population of aberrant (tumor) cells and forge a novel class of chemotherapeutics which have the potential to be much more potent than general inhibitors of cell proliferation or inducers of cell death. In the era of
personalized medicine, and in combination with our emerging diagnostic methodologies, we believe this program will generate a novel pipeline of drugs that promise cancer patients greater proficiency with fewer side effects.

STYLE="margin-top:18px;margin-bottom:0px">Immunotherapeutics and Related Assay Systems

The
technologies licensed from the Buck Institute also included a novel immunotherapeutic/anti-cancer compound (T9) and highly sensitive cell-based assay systems for the discovery of additional immune-modulating drugs. Immune-modulating drugs represent
an emerging class of therapies with broad clinical application in the treatment of cancer, allergies, inflammation, autoimmunity and tissue transplantation. T9 is a highly potent bi-functional molecule with the ability to kill cancer cells and to
activate the immune response to recognize cancer cells in a manner analogous to childhood vaccination.

T9 was originally discovered using
robust ultra-sensitive cell-based assay systems which respond to minute amounts of potential immune-modulating drugs. Over time, these systems were further modified to allow for their use in high throughput screens for the identification of
compounds that can control the magnitude and quality of the immune response. The immune-modulating high throughput screening systems (IMHTSS) technologies are important tools for the discovery of novel agents which modulate the immune response
through controlling the type and degree of inflammation. “Hits” resulting from the screening of synthetic and natural product libraries using the IMHTSS technologies are anticipated to be further developed to act as immune adjuvants in
improving existing vaccination platforms or to inhibit the immune response in the context of allergies (such as asthma) or autoimmune diseases (such as type I diabetes, multiple sclerosis and lupus erythematosus).

STYLE="margin-top:18px;margin-bottom:0px">Translational Molecular Bioscience at CNSI

The
California NanoSystems Institute (CNSI) is a multidisciplinary research center at UCLA whose mission is to encourage university-industry collaboration and to enable the rapid commercialization of discoveries in

 


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nanosystems. CNSI members include some of the world’s preeminent scientists, and the work conducted at the institute represents world-class expertise in
five targeted areas of nanosystems-related research: renewable energy, environmental nanotechnology and nanotoxicology, nanobiotechnology and biomaterials, nanomechanical and nanofluidic systems, and nanoelectronics, photonics and architectonics.

In July 2007, we entered into a research collaboration agreement with CNSI under which the parties agreed to collaborate on early research
in nanobiotechnology for the advancement of new technologies in medicine. Under the agreement, we committed to fund up to $10 million over ten years in two tranches of $5 million for research projects selected by a committee comprised equally of our
and CNSI representatives. Any intellectual property resulting from the projects will be owned by CNSI. However, we have first right to negotiate an option or license to all of such intellectual property on commercially reasonable terms, including
royalties. In addition, if the parties are unable to successfully negotiate a license, CNSI may not license the intellectual property to another party at a lower rate than offered to us for a specified period of time. The term of the agreement is
ten years, but either party can terminate on 30 days notice and the funding commitment for the second $5 million is subject to mutual agreement within 30 days of the end of the fifth year of the agreement.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">This partnership provides CNSI and our researchers the opportunity to jointly pursue innovative approaches to the diagnosis and treatment of
life-threatening diseases, leveraging the complementary resources and skills of both organizations. Working side by side with CNSI researchers, our scientists will focus on rapidly and seamlessly translating early scientific discovery into practical
application. The Abraxis/CNSI Research Collaboration Lab has been designed to integrate and support multidisciplinary science, including cellular and molecular biology (including high-throughput discovery), nanodetection methodologies and tools for
diagnostic discoveries, medicinal and synthetic chemistry, computational structural biology (including rational approaches to drug discovery) and bioengineering of nanodevices and nanomaterials.

STYLE="margin-top:18px;margin-bottom:0px">Biosimilars

In June 2007, we entered into a license
agreement with Biocon Limited under which we licensed the right to develop and commercialize a biosimilar version of G-CSF (granulocyte-colony stimulating factor) in North America and the European Union. G-CSF is an haematopoietic growth factor that
works by encouraging the bone marrow to produce more white blood cells. Therapeutic G-CSF is primarily used for the treatment of neutropenia, the lowering of the white blood cells that fight infections. Biocon has received regulatory approval of its
G-CSF from the Drugs Controller General of India (DCGI) for the treatment of neutropenia in cancer patients. The biological activity of Biocon’s G-CSF used in clinical trials was evaluated by the National Institute of Biological Standards and
Control (NIBSC), UK, which provides independent testing of biological medicines. The NIBSC found that the potency of Biocon’s drug met the necessary requirements of a biosimilar G-CSF.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%;padding-bottom:3px;line-height:95%; vertical-align:top">In November 2007, we entered into a license agreement with Green Cross Corporation under which we
licensed the right to develop and commercialize five biosimilars for the United States and Canada on an exclusive basis: Enbrel® (etanercept), pegylated G-CSF, recombinant Factor VIII,
Interferon-Alpha and Erythropoietin. Etanercept is a chimeric protein designed to neutralize tumor necrosis factor (TNF), an important regulator of local inflammatory response. Pegylated G-CSF, like G-CSF, is primarily used for the treatment of
neutropenia, but its half-life is greatly increased compared to G-CSF because of the polyethylene glycol treatment (a process also commonly referred to as “pegylating”), thereby reducing the frequency and dose of the injections required to
sustain a patient’s neutrophil levels. Recombinant Factor VIII is a clotting factor that is essential for reestablishing hemostasis in hemophiliac patients. Interferon-Alpha is a powerful, multifunctional protein produced by innate cells of the
immune system to combat viral infections. Erythropoietin is a protein produced mainly by cells of the kidneys to maintain red blood cell levels by inhibiting their ability to commit cellular “suicide” and stimulate their production from
precursors and is approved for patients experiencing anemia due to a variety of mechanisms including chronic renal failure and certain anti-cancer chemotherapies.

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