[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4920-4921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1669]


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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.

Allele Specific shRNA for Nanog, and Its Use To Treat Cancer

    Description of Technology: Cancer stem cells are currently thought 
to be major participants in resistance to radiation therapy and 
chemotherapy; they are also thought to drive the spread of cancer 
through metastasis. It has been postulated that genes involved in early 
embryogenesis, primarily transcription factor Nanog but also Oct4 and 
SOX2, may be reactivated to maintain the properties of cancer stem 
cells, any treatment that inhibits such genes may therefore inhibit the 
progression of cancer and lead to improved survival and other clinical 
outcomes.
    The NIH investigators discovered that the expression of NanogP8, a 
pseudogene of Nanog, is upregulated in human colorectal cancer 
spheroids formed in serum-free medium. NanogP8 has also been reported 
to be upregulated in human prostate cancer and glioblastomas. An 
inhibitory RNA molecule was identified by the investigators to knock 
down expression of NanogP8, without interfering with expression of 
Nanog. The discovery may improve the safety of a shRNA-based gene 
therapy and improve its chances for acceptance as a clinical therapy.
    Applications and Market:
     This invention may provide a new therapy to target 
colorectal cancer as well as a few other cancers for treatment.
     Cancer is the second leading cause of death, and 
colorectal cancer is the fourth most common form of cancer in the U.S. 
Development of more effective cancer therapies is always in need.
    Development Status: Pre-clinical stage of development.
    Inventors: John M. Jessup and Jingyu Zhang (NCI).
    Patent Status: U.S. Provisional Application No. 61/420,214 filed 06 
Dec 2010 (HHS Reference No. E-294-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Experimental Carcinogenesis is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this specific 
gene therapy to target colorectal and other human carcinomas. Please 
contact John Hewes, Ph.D. at 301-435-3121 or [email protected] for 
more information.

Compositions and Methods for Controlling Neurotropic Viral Pathogenesis 
by Micro-RNA Targeting

    Description of Technology: There are more than seventy (70) single-
stranded, positive-sense RNA viruses in the arthropod-borne flavivirus 
genus of the Flaviviridae family, many of which are important human 
pathogens that cause a devastating and often fatal neuroinfection. 
Flaviviruses are transmitted in nature to various mammals and birds 
through the bite of an infected mosquito or tick; they are endemic in 
many regions of the world and include mosquito-borne yellow fever 
(YFV), Japanese encephalitis (JEV), West Nile (WNV), St. Louis 
encephalitis (SLEV), dengue viruses (DEN) and the tick-borne 
encephalitis viruses (TBEV). During the past two decades, both 
mosquito-borne and tick-borne flaviviruses have emerged in new 
geographic areas of the world where previously they were not endemic 
and have caused outbreaks of diseases in humans and domestic animals.
    Long-term experience with the only two successful live attenuated 
flavivirus vaccines has demonstrated that live attenuated virus 
vaccines are an efficient approach to prevent diseases caused by 
virulent flaviviruses because, in most cases, just a single dose of the 
vaccine provides a long-lasting protective immunity in humans that 
mimics the immune response following natural infection.
    This application claims recombinant attenuated neurotropic 
flaviviruses comprising nucleic acid sequences complementary to the 
target sequences of microRNAs. The application also claims live 
attenuated chimeric flaviviruses, where the first flavivirus is a 
different flavivirus from the second flavivirus.
    Applications:
     Vaccines for the prevention of multiple flavivirus 
infections.
     Use of human clinically-tested live attenuated dengue 
vector.
    Advantages:
     Novel vaccine candidate.
     Rapid production time.
     Low manufacturing cost.
    Development Status: Preclinical studies have been conducted by the 
inventors.
    Inventors: Alexander Pletnev and Brian Heiss (NIAID).

[[Page 4921]]

    Patent Status: U.S. Provisional Application No. 61/455,261 filed 14 
Oct 2010 (HHS Reference No. E-197-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].

Method for Detection and Quantification of PLK1 Expression and Activity

    Description of Technology: Polo-like kinase 1 (Plk1) plays a role 
in the regulation of the cell cycle and control of cellular 
proliferation. Because Plk1 is associated with neoplastic 
transformation of human cells, expression of this protein has been 
proposed as a prognostic marker for many types of malignancies. In 
mammalian cells, four Plks exist, but their expression patterns and 
functions appear to be distinct from each other. Available for 
licensing is a Plk1 ELISA assay using peptide substrates that are 
specific for Plk1, in that they are phosphorylated and bound by Plk1, 
but not by the related polo kinases Plk2, Plk3 and Plk4.
    By exploiting a unique Plk1-dependent phosphorylation and binding 
property, an easy and reliable ELISA assay has been developed to 
quantify Plk1 expression levels and kinase activity. With this highly 
sensitive assay, Plk1 activity can be measured with 2-20 microgram of 
total lysates without immunoprecipitation or purification steps. Since 
deregulated Plk1 expression has been suggested as a prognostic marker 
for a wide range of human malignancies, this assay may provide an 
innovative tool for assessing the predisposition for cancer 
development, monitoring cancer progression, and estimating the 
prognosis of various types of cancer patients.
    Applications:
     Optimized PBIP1 polypeptides, a natural substrate of Plk1, 
with enhanced specificity and sensitivity over the native PBIP1 
sequence.
     ELISA assay to quantify Plk1 expression and kinase 
activity.
    Advantages:
     Rapid, highly sensitive assay that requires lower amounts 
of starting material than conventional immunoprecipitation assays.
     Assay that is selective for Plk1.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market:
     Cancer is the second leading cause of death in United 
States.
     An estimated 1,529,560 new cancer cases and 569,490 deaths 
from cancer occurred in the United States in 2010.
     In vitro cancer diagnostic market will be worth an 
estimated $8 billion by the end of 2012.
    Inventors: Kyung S. Lee and Jung-Eun Park (NCI).
    Publications:
    1. JE Park et al. Direct quantification of polo-like kinase 1 
activity in cells and tissues using a highly sensitive and specific 
ELISA assay. Proc Natl Acad Sci USA. 2009 Feb 10;106(6):1725-1730. 
[PubMed: 19181852]
    2. KS Lee et al. Mechanisms of mammalian polo-like kinase 1 (Plk1) 
localization: self-versus non-self-priming. Cell Cycle 2008 
Jan;7(2):141-145. [PubMed: 18216497]
    3. KS Lee et al. Self-regulated mechanism of Plk1 localization to 
kinetochores: lessons from the Plk1-PBIP1 interaction. Cell Div. 2008 
Jan 23;3:4. [PubMed: 18215321]
    4. YH Kang et al. Self-regulated Plk1 recruitment to kinetochores 
by the Plk1-PBIP1 interaction is critical for proper chromosome 
segregation. Mol Cell. 2006 Nov 3;24(3):409-422. [PubMed: 17081991]
    Patent Status: U.S. Patent Application No. 12/992,887 filed 15 Nov 
2010 (HHS Reference No. E-091-2008/0-US-03).
    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Laboratory of Metabolism, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the PLK1 ELISA assay described 
above. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

Immunoglobulin-Producing Mouse Plasmacytomas

    Description of Technology: Overall cancer costs in the U.S. in 2006 
are estimated at $206.3 billion. The World Health Organization predicts 
upwards of 15 million new cancer cases globally by 2020. There remains 
a significant unmet need for new therapies to treat cancer, as well as 
a need to further understand the role of the immune system in cancer 
susceptibility.
    Available for licensing are isolated immunoglobulin-producing mouse 
plasmacytomas (PCTs). Each tumor produces only one species of 
monoclonal immunoglobulin (Ig). When transplanted into mice, these 
plasma cell tumors will continue to produce only the same unique Ig 
molecules. Some (5-10%) of the Igs specifically bind antigens.
    Applications:
     To understand the underlying process of neoplastic 
development.
     To identify the genes that control tumor susceptibility 
and resistance.
     To investigate the antigen binding activities of myeloma 
proteins.
     To study Ig synthesis.
     To classify the various different classes of Igs (IgG, 
IgA, IgM).
     As a fusion partner to make monoclonal antibodies.
    Advantages: Provide an unlimited source of pure monoclonal Ig 
molecules.
    Inventor: Michael Potter (NCI).
    Relevant Publications:
    1. Potter M, Fahey JL, Pilgrim HI. Abnormal serum protein and bone 
destruction and transmissible mouse plasma cell neoplasm (multiple 
myeloma). Proc Soc Exp Biol Med. 1957 Feb;94(2):327-333.
    2. Nathans D, Fahey JL, Potter M. The formation of myeloma protein 
by a mouse plasma cell tumor. J Exp Med. 1958 Jul 1;108(1):121-130. 
[PubMed: 13549645]
    3. Potter M, Boyce CR. Induction of plasma cell neoplasms in strain 
BALB/c mice with mineral oil and mineral oil adjuvants. Nature. 1962 
Mar 17;193:1086-1087.
    4. Andersen PN, Potter M. Induction of plasma cell tumors in BALB/c 
mice with 2,6,10,14-tetramethylpentadecane (pristane). Nature. 1969 Jun 
7;222(5197):994-995.
    Patent Status: HHS Reference No. E-277-2001/0--Research Material. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for biological materials licensing 
only.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
[email protected].

    Dated: January 19, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-1669 Filed 1-26-11; 8:45 am]
BILLING CODE 4140-01-P