[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28857-28858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11602]


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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, 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.

FOR FURTHER INFORMATION CONTACT: 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 Diagnostic Kit for Assessing Exposure or Infection by the Koala 
Family of Retroviruses

    Description of Technology: Inventors at the NIH have discovered a 
new family of infectious koala retroviruses that are correlated with 
the development of malignant neoplasias, including lymphomas and 
leukemias. This invention relates to a diagnostic kit for assessing 
exposure or infection by a koala retrovirus. The kit consists of 
specific primers and probes for the detection of three distinct 
subtypes of infectious koala retrovirus and may be useful in various 
species, including humans, primates, and koalas. Infectious koala 
retroviruses have been shown to infect human cells in culture, though 
the health implications in humans have not yet been fully determined.
    Potential Commercial Applications:
     A diagnostic kit for assessing exposure or infection by 
the koala family of retroviruses
     May be useful in monitoring effectiveness of 
antiretroviral treatment
    Competitive Advantages: Detection of newly discovered subtypes of 
infectious koala retroviruses.
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Maribeth V. Eiden (NIMH), Wenqin Xu (NIMH), William M. 
Switzer (CDC), HaoQiang Zheng (CDC)
    Intellectual Property: HHS Reference No. E-053-2013/0--US 
Application No. 61/784,763 filed 14 Mar 2013
    Licensing Contact: Charlene Sydnor, Ph.D.; 301-435-4689; 
[email protected]
    Collaborative Research Opportunity: The National Institute of 
Mental Health is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize A Diagnostic Kit for Assessing Exposure or 
Infection by the Koala Family of Retroviruses. For collaboration 
opportunities, please contact Suzanne L. Winfield, Ph.D. at 
[email protected] or 301-402-4324.

Retroviral Vector Packaging Cell Lines and Purification Methods for 
Gene Therapy

    Description of Technology: This invention relates to a novel 
gammaretroviral vector packaging cell line and method of producing 
gammaretroviral vectors suitable for gene therapy. The described 
vectors may contain the gibbon ape leukemia virus (GALV) envelope with 
a CD11D8 epitope tag enabling their purification on a monoclonal 
antibody conjugated column. These vectors have several advantages over 
existing systems, including a broader host range, higher infectivity, 
and lower potential for replication. Further, purification of 
retroviral vector particles via an epitope tag may remove cellular 
components and debris toxic to target cells and tissues, providing a 
safer method of delivery for patients receiving gene therapy.
    Potential Commercial Applications: Retroviral vector particles for 
gene therapy.
    Competitive Advantages:
     Broader host range
     Higher infectivity
     Lower potential for replication
     Decreased toxicity after purification
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Maribeth V. Eiden and Wenqin Xu (NIMH)
    Intellectual Property: HHS Reference No. E-036-2013/0--US 
Application No. 61/759,516 filed 01 Feb 2013
    Licensing Contact: Charlene Sydnor, Ph.D.; 301-435-4689; 
[email protected]
    Collaborative Research Opportunity: The National Institute of 
Mental Health is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize

[[Page 28858]]

Retroviral Vector Packaging Cell Lines and Purification Methods for 
Gene Therapy. For collaboration opportunities, please contact Suzanne 
L. Winfield, Ph.D. at [email protected] or 301-402-4324.

Enhanced Cancer Immunotherapy Using microRNA-155

    Description of Technology: Tumor immunotherapy is a promising 
approach for the treatment of cancer. However, current T cell-based 
immunotherapies are limited by the poor engraftment and functionality 
of the transferred T cells. Moreover, lymphodepleting regimens used to 
enhance engraftment and function of transferred tumor-reactive T cells 
are plagued by life-threatening side effects.
    The scientist at the NIH recently discovered that the 
overexpression of microRNA-155 (miR-155) in tumor-reactive murine CD8+ 
T cells can enhance T cell proliferation and anti-tumor efficacy 
without lymphodepletion and exogenous cytokine administration. 
Consequently, using the miR155 overexpressing human CD8+ T cells could 
provide a safer, more effective T cell-based immunotherapy. This 
invention describes miR155 CD8+ T cell compositions and methods of 
using the miR155 CD8+ T cells to treat cancer through adoptive 
immunotherapy.
    Potential Commercial Applications: Use in enhanced adoptive 
immunotherapy to treat cancer.
    Competitive Advantages:
     T cells with enhanced proliferation, survival, and 
function.
     Robust tumor response without the need of lymphodepletion 
and exogenous cytokine support.
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Yun Ji, Luca Gattinoni, Nicholas Restifo (NCI)
    Publication: Dudda JC, et al. MicroRNA-155 Is Required for Effector 
CD8(+) T Cell Responses to Virus Infection and Cancer. Immunity. 2013 
Apr 18;38(4):742-53. [PMID 23601686]
    Intellectual Property: HHS Reference No. E-272-2012/0--US 
Provisional Application No. 61/716,653 filed 22 Oct 2012
    Licensing Contact: Whitney Hastings; 301-451-7337; 
[email protected]
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
the use of microRNA-155 to enhance T cell-based immunotherapies. For 
collaboration opportunities, please contact Luca Gattinoni at 
[email protected] or 301-451-6914, or Nicholas Restifo at 
[email protected] or 301-496-4904.

Pyruvate Kinase M2 Activators for the Treatment of Cancer

    Description of Technology: This technology describes a series of 
small-molecule activators of the pyruvate kinase M2 isoform (PK-M2).
    Pyruvate kinase (PK) is a critical metabolic enzyme that catalyzes 
the last step of the glycolytic pathway. It exists in several isoforms 
with different patterns of tissue expression. One isoform, PK-M2, is 
expressed in cells with a high rate of nucleic acid synthesis, 
including most tumors, which makes this enzyme an attractive target for 
cancer therapy. PK-M2 can occur in either a tetrameric form or a 
dimeric form in proliferating cells; a high tetramer to dimer ratio 
leads to energy production, while a low ratio channels metabolites into 
synthetic processes. In tumor cells, oncoproteins induce dimerization 
of PK-M2, resulting in the inactive form of the protein and allowing 
synthesis of building blocks for cell proliferation. Activation of PK-
M2 in these cells may prevent the buildup of metabolic intermediates 
and thereby stall tumor cell proliferation. Further, after embryonic 
development PK-M2 expression is primarily restricted to tumor cells, so 
specific activators of PK-M2 would be expected to affect only tumor 
cells, and would be less likely to be toxic in normal tissues.
    Investigators at the National Center for Advancing Translational 
Sciences have discovered a series of small molecules that specifically 
activate the PK-M2 isoform and that may be useful for the treatment of 
cancer. These compounds are based upon a substituted thieno[3,2-
b]pyrrole[3,2-d]pyridazinone scaffold.
    Potential Commercial Applications: Targeted therapeutic agent for 
cancer and other cell proliferation disorders.
    Competitive Advantages:
     Compounds are specific to one isoform of pyruvate kinase.
     Compounds target tumor cells and not normal cells, so side 
effects may be reduced.
     Compounds are small molecules which may be further 
optimized.
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Craig J. Thomas, Jian-Kang Jiang, Matthew B. Boxer, Min 
Shen, Douglas S. Auld (NCATS)
    Publications:
    1. Anastasiou D, et al. Pyruvate kinase M2 activators promote 
tetramer formation and suppress tumorigenesis. Nat Chem Biol. 2012 
Oct;8(10):839-47. [PMID 22922757]
    2. Anastasiou D, et al. Inhibition of pyruvate kinase M2 by 
reactive oxygen species contributes to cellular antioxidant responses. 
Science. 2011 Dec 2;334(6060):1278-83. [PMID 22052977]
    3. Jiang J, et al. Evaluation of thieno[3,2-b]pyrrole[3,2-
d]pyridazinones as activators of the tumor cell specific M2 isoform of 
pyruvate kinase. Bioorg Med Chem Lett. 2010 Jun 1;20(11):3387-93. [PMID 
20451379]
    Intellectual Property: HHS Reference No. E-298-2011/1--US 
Provisional Application No. 61/752,698 filed 15 Jan 2013
    Related Technologies:
    HHS Reference No. E-326-2008/0--
     US Patent Application No. 13/123,297 filed 25 Apr 2011
     US Patent Application No. 13/433,656 filed 29 Mar 2012
     Various international patent applications filed
    HHS Reference No. E-120-2010/0--
     US Patent Application No. 13/643,594 filed 26 Oct 2012
     Various international patent applications filed
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
[email protected]
    Collaborative Research Opportunity: The National Center for 
Advancing Translational Sciences (NCATS) is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize Pyruvate Kinase 
M2 Activators for the Treatment of Cancer. For collaboration 
opportunities, please contact the Office of Strategic Alliances at 
[email protected].

    Dated: May 10, 2013.
 Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-11602 Filed 5-15-13; 8:45 am]
BILLING CODE 4140-01-P