[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67738-67740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

A Family of Small Molecules for Selective Inhibition of Wip1 
Phosphatase

    Description of Technology: The Wip1 phosphatase acts on proteins 
containing a particular phosphorylated amino acid sequence. Studies 
have shown that Wip1 is overexpressed in a number of human cancers, 
including breast cancer, neuroblastoma and ovarian cancer. Wip1 
activity has also been shown to have a suppressive effect on the tumor 
suppressor p53. This suggested that inhibition of Wip1 could be of 
therapeutic value in the treatment of cancer.
    NIH inventors have developed small molecules that simulate the 
structure of the amino acid sequence that Wip1 recognizes. The 
structure of the small molecules allows for specific targeting to Wip1. 
These small molecules have the ability to significantly inhibit Wip1 
phosphatase activity at the micromolar level. As a result, these small 
molecules can be used in the design of therapeutics for cancers that 
overexpress Wip1.
    Applications: Treatment of cancer, including but not limited to 
breast cancer, ovarian cancer and neuroblastoma.
    Can be used either alone or in combination with other known anti-
cancer therapeutics.
    Advantages: Structure of the inhibitor allows targeting of Wip1 
without inhibition of related phosphatases and their biological 
processes, possibly leading to fewer undesired effects during 
treatment.
    Small molecules are stable and have the ability to effectively 
penetrate cells.
    Can be applied to many different types of cancer.
    Benefits: The current lack of Wip1 inhibitors means that 
development of the small molecules could lead to the occupation of a 
significant position in the cancer therapeutic market.
    The successful inhibition of a new target in cancer therapy could 
provide far-reaching social benefit in the treatment of multiple 
cancers.
    Inventors: Ettore Appella et al. (NCI).

[[Page 67739]]

    U.S. Patent Status: U.S. Patent Application No. 60/969,258 (HHS 
Reference No. E-302-2007/0-US-01).
    Licensing Contact: David A. Lambertson, Ph.D.; Phone: (301) 435-
4632; Fax: (301) 042-0220; E-mail: [email protected].
    Collaborative Research Opportunity: The National Cancer Institute's 
Laboratory of Cell Biology is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize therapeutics for cancers that 
overexpress Wip1. Please contact John D. Hewes, Ph.D. at 301-435-3121 
or [email protected] for more information.

Selenocysteine Mediated Hybrid Antibody Molecules

    Description of Technology: Available for licensing is a new class 
of hybrid molecules composed of an antibody, or antibody fragment, and 
a small synthetic molecule (such as a small molecule inhibitor, or 
cytotoxic compound). These biological and chemical components are 
covalently linked at an engineered selenocysteine near the C-terminus 
of the antibody, or antibody fragment. Through this covalent linkage, 
the chemical and the biological component can acquire properties of one 
another. For example, the synthetic molecule acquires antibody 
properties such as circulatory half-life, effector functions, and 
ability to interfere with protein interactions whereas the antibody, or 
antibody fragment, acquires properties of the small synthetic molecule 
such as specificity, affinity, and stability to bind to targets that 
are sterically inaccessible to immunoglobulins. The technology can also 
be used to equip an antibody, or antibody fragment, with a small 
synthetic molecule that enhances target destruction or imaging 
capabilities through site-selective biotinylation, PEGylation, addition 
of an imaging agent, or addition of a cytotoxic agent such as a 
chemotherapeutic drug or a chelate for radioisotope labeling. The 
hybrid antibody molecules can be engineered with a variety of small 
synthetic molecules, and the combination of immunogenic properties and 
those of the small synthetic molecules results in compounds with 
powerful target destruction or imaging capabilities. This technology 
could be applied towards the targeted delivery of small synthetic 
molecules to various cell surface receptors, and may have applicability 
as a prevention, diagnosis, or therapy for numerous disease states.
    Applications: Potent novel compositions that retain immunogenic 
properties and those of small synthetic molecules that can be produced 
at a large scale; Method to prevent, diagnose, and treat cancer, 
infectious diseases and autoimmune diseases.
    Market: Monoclonal antibody market is projected to exceed $30 
billion by 2010; Revenue from antibodies for therapeutics and 
diagnostic uses are expected to grow at an average annual growth rate 
of 11.5%.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Christoph Rader et al. (NCI).
    Patent Status: U.S. Provisional Application No. 60/909,665 filed 02 
Apr 2007 (HHS Reference No. E-146-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301/435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Experimental Transplantation and Immunology 
Branch, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize Selenocysteine Mediated Hybrid Antibody Molecules. Please 
contact Dr. Christoph Rader at (301) 451-2235 or [email protected] 
for more information.

SLCO1B3 Genotyping to Predict a Survival Prognosis of Prostate Cancer

    Description of Technology: Steroid hormones have been implicated in 
playing a fundamental role in the pathogenesis of prostate cancer. 
Polymorphisms in the genes that code for enzymes or hormones involved 
in androgen regulatory pathway are proposed to influence an 
individual's risk for developing prostate cancer. Since many membrane 
transporters are modulators of steroid hormones absorption and tissue 
distribution, genetic polymorphisms in genes encoding these 
transporters may account for the risk of prostate cancer and the 
predicting of survival. The OATP1B3 (formerly OATP8) steroid uptake 
transporter is overexpressed in prostate cancer, and polymorphisms in 
SLCO1B3 have been associated with altered testosterone uptake, and also 
an increased prostate cancer risk.
    This invention identifies two polymorphic genetic markers in the 
SLCO1B3 (formerly SLC21A8) gene, called 334T>G and 699G>A, that can be 
measured in genomic DNA obtained from a blood sample to predict 
survival from diagnosis of prostate cancer in that individual patient. 
This genetic profiling result has profound clinical applications in 
diagnosis for each individual patient and ultimate treatment regimen. 
Specifically, the inventors have provided a correlation between 
clinical outcome of SLCO1B3 genotype with median survival of androgen 
independent prostate cancer. They have also shown that the genotype is 
predictive of testosterone uptake through the OATP1B3 transporter, and 
this information is useful to inform clinical decisions regarding 
antiandrogen therapy.
    Advantages and Applications: SLCO1B3 genotyping can be used in 
combination on a gene chip with several polymorphisms known to predict 
survival of prostate cancer patients. Thus the OATP1B3 polymorphism 
would be one genetic marker in a series of other markers that would be 
used to inform clinical decisions.
    SLCO1B3 upregulation can be used as a prognostic tool.
    Development Status: Initial experiments have been performed with 
clinical samples from patients with prostate cancer.
    Inventors: William D. Figg et al. (NCI).
    Patent Status: U.S. Provisional Application No. 60/879,503 filed 08 
Jan 2007 (HHS Reference No. E-083-2007/0-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Mojdeh Bahar, J.D.; 301/435-2950; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute's 
Medical Oncology Branch is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize the use of the SLCO1B3 genotyping to inform 
clinical decisions regarding drug treatment, or prognosis of prostate 
cancer. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

A New Method for Determining Level of Immunosuppression in Humans

    Description of Technology: These inventions describe a method of 
determining the level of immunosuppression in a human subject by 
determining the level of expression of at least one selected T-Cell 
Receptor subunit protein, or protein in the T lymphocyte signal 
transduction pathway, and comparing the level to that found in healthy 
individuals.
    Applications: The method can be used to identify candidates for 
autologous adoptive immunotherapy

[[Page 67740]]

and for identification of agents which cause or reverse 
immunosuppression.
    Development Status: Pre-clinical stage.
    Inventors: Augusto C. Ochoa et al. (NCI).
    Patent Status: U.S. Patent No. 5,583,002 issued 10 Dec 1996 (HHS 
Reference No. E-231-1995/1-US-01);
    U.S. Patent No. 5,556,763 issued 17 Sep 1996 (HHS Reference No. E-
231-1995/3-US-01);
    U.S. Patent No. 5,889,143 issued 10 Dec 1996 (HHS Reference No. E-
231-1995/3-US-02);
    U.S. Patent Application No. 09/280,655 filed 29 Mar 1999 (HHS 
Reference No. E-231-1995/3-US-03);
    U.S. Patent No. 5,658,744 issued 19 Aug 1997 (HHS Reference No. E-
232-1995/0-US-01);
    U.S. Patent No. 5,965,366 issued 12 Dec 1999 (HHS Reference No. E-
232-1995/1-US-01); and any foreign equivalent patents and patent 
applications.
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: John Stansberry; 301/435-5236; 
[email protected].

    Dated: November 14, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-23193 Filed 11-29-07; 8:45 am]
BILLING CODE 4140-01-P