[Federal Register Volume 72, Number 205 (Wednesday, October 24, 2007)]
[Notices]
[Pages 60381-60382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20909]


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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.

Novel Micro-RNA Sequence Transforms Non-Functional T-Lymphocytes to 
Highly Functional: Key to Improved Immunotherapy for the Treatment of 
Cancers

    Description of Technology: This technology is directed to the 
therapeutic use of microRNA-181a in the adoptive immunotherapy of 
cancer.
    The adoptive transfer of anti-tumor T cells after a lymphodepleting 
regimen can result in the regression of metastatic cancer both in mouse 
and human, but the production of highly-reactive, tumor-specific T 
cells still represents a barrier to broad implementation of T cell-
based immunotherapies. This technology enables the use of microRNA 
(miR)-181a, a recently identified intrinsic modulator of T-cell 
receptor (TCR) signaling, to improve anti-tumor T cell responsiveness. 
Micro-RNAs are short RNA molecules that regulate the activity of genes 
and appear to control biological processes.
    We found that genetic engineering of T lymphocytes with miR-181a 
dramatically augmented the function of poorly responsive human tumor-
infiltrating lymphocytes and TCR-engineered peripheral blood 
lymphocytes, resulting in potent anti-tumor reactivity. Furthermore, in 
a mouse model, miR-181a increased the function of self/tumor-specific 
CD8\+\ T cells enabling effective tumor destruction in the absence of 
vaccination or exogenous cytokines that were otherwise essential 
requirements. This technology is the first reported use of a miRNA gene 
as tool in the treatment of disease.
    Applications: The microRNA sequence (``miR-181a'') can be used to 
enhance the tumor recognizing capacity of T-lymphocytes against several 
tumors.
    This technology can be used for selective treatment of several 
cancers more effectively.
    Advantages: Proof-of concept pre-clinical data are available and 
clinical trials are currently being planned.
    This technology is based on adoptive immunotherapy, which is now an 
accepted and effective form of cancer treatment.
    Benefits: The microRNA identified has the potential to broaden and 
enhance the scope of adoptive immunotherapy.
    Development Status: Pre-clinical work has been completed and 
clinical studies are forthcoming.
    Inventors: Dr. Nicholas P. Restifo et al. (NCI).
    Relevant Publication: Q Li et al. miR-181a is an intrinsic 
modulator of T cell sensitivity and selection. Cell. 2007 Apr 
6;129(1):147-161.
    Patent Status: U.S. Provisional Application filed 25 May 2007 (HHS 
Reference No. E-224-2007/0-US-01).
    Licensing Status: This technology is available for licensing under 
an exclusive or non-exclusive patent license.
    Licensing Contact: Michelle A. Booden, PhD; 301/451-7337; 
[email protected].
    Collaborative Research Opportunity: The Surgery Branch of the 
National Cancer Institute is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the therapeutic use of microRNA-
181a in the adoptive immunotherapy of cancer. Please contact John D. 
Hewes, PhD at 301-435-3121 or [email protected] for more information.

[[Page 60382]]

Use of HDAC Inhibitors for the Prevention and Cure for Brain Metastases 
of Cancers

    Description of Technology: The increased survival of primary and 
metastatic cancers consequential of improved therapies has resulted in 
increased brain metastases. Few treatment options are available for 
cancer patients with central nervous system (CNS) metastasis. There is 
a need for new treatment options for CNS metastases especially brain 
metastases originating outside the CNS.
    The present invention provides a method of treating a localized 
carcinoma CNS metastasis of extra-CNS origin. More specifically, the 
method comprises of treating a localized carcinoma CNS metastasis of 
extra-CNS origin with a histone deacetylase (HDAC) inhibitor (HDACI) 
originating in one or more organs such as lung, breast, liver, colon, 
and prostate. The HDACI can be any HDACI that is capable of crossing 
the blood-brain barrier (BBB) such as vorinostat.
    Advantages: Vorinostat has been approved by the FDA for the 
treatment of cutaneous manifestations in patients with cutaneous T-cell 
lymphoma (CTCL) who have progressive, persistent or recurrent disease 
on or following two systemic therapies, and as such, has efficacy and 
tolerability data.
    Benefits: More than 40,000 breast cancer deaths are estimated to 
occur in 2007. Majority of these deaths are due to metastases of the 
breast cancer. Approximately, 10%-20% of women with metastatic breast 
cancer are estimated to develop brain metastasis and the median 
survival after brain cancer metastasis is only one year. This 
technology may effectively treat breast cancer brain metastases and 
thus improve overall survival and quality of life of patients suffering 
from cancer. The current cancer chemotherapeutic market is valued at 
$42 billion and expected to grow.
    Inventors: Patricia S. Steeg et al. (NCI).
    Development Status: In vivo animal model data available with 
vorinostat.
    Patent Status: U.S. Provisional Application No. 60/891,856 filed 02 
Feb 2007 (HHS Reference No. E-084-2007/0-US-01).
    Licensing Contact: John Stansberry; 301/435-5236; 
[email protected].

    Dated: October 11, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-20909 Filed 10-23-07; 8:45 am]
BILLING CODE 4140-01-P