Government-Owned Inventions; Availability for Licensing, 8724 [2014-03083]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 79, Number 30 (Thursday, February 13, 2014)]
[Notices]
[Page 8724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03083]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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. 209 and 37 CFR part 404 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.

Tumor Infiltrating Lymphocytes From Human Papillomavirus-Positive 
Tumors for the Treatment of Cancer

    Description of Technology: Human papillomaviruses (HPV) cause 
anogenital and oropharyngeal cancers, and these malignancies express 
viral oncoproteins that can be recognized by T cells. When HPV-
associated cancers spread they are incurable and difficult to palliate 
with existing treatments.
    Tumor infiltrating lymphocytes (TIL) have been used successfully to 
treat advanced stage malignant melanoma, however their use has been 
primarily limited to this disease. This technology describes a novel 
TIL therapy for treating HPV-associated cancers. The NIH inventors have 
found TIL can be grown from HPV positive tumors at grade and scale 
suitable for clinical use and that they can recognize the HPV 
oncoproteins that drive transformation and survival of cancer cells. 
The inventors have initiated a clinical trial for the treatment of 
advanced HPV positive cancers that are refractory to standard 
chemotherapy using HPV-TIL. Early results of the clinical trial suggest 
that HPV-TIL has activity in chemotherapy-refractory advanced disease 
for which no standard treatment options are available.
    Potential Commercial Applications: HPV-TIL therapy is a novel 
treatment approach that may mediate long-lasting tumor regression from 
a single dose of cells.
    Competitive Advantages: Early clinical results suggest that HPV-TIL 
has activity in chemotherapy-refractory advanced disease for which no 
standard treatment options are available.
    Development Stage: In vitro data available (human)
    Inventors: Christian Hinrichs and Steven A. Rosenberg (NCI)
    Publications:
    1. Piersma SJ, et al. Human papilloma virus specific T cells 
infiltrating cervical cancer and draining lymph nodes show remarkably 
frequent use of HLA-DQ and -DP as a restriction element. Int J Cancer 
2008 Feb 1;122(3):486-94. [PMID 17955486]
    2. de Vos van Steenwijk PJ, et al. An unexpectedly large polyclonal 
repertoire of HPV-specific T cells is poised for action in patients 
with cervical cancer. Cancer Res. 2010 Apr 1;70(7):2707-17. [PMID 
20233872]
    Intellectual Property: HHS Reference No. E-494-2013/0--US 
Provisional Application No. 61/846,161 filed 15 July 2013
    Related Technology: HHS Reference No. E-495-2013/0--US Provisional 
Application No. 61/846,167 filed 15 July 2013
    Licensing Contact: Whitney A. Hastings; 301-451-7337; 
hastingw@mail.nih.gov

Improved Culture Medium for Stem Cell Maintenance and Differentiation

    Description of Technology: A novel low protein culture medium with 
defined chemical components that allows pluripotent stem cell 
maintenance and differentiation is disclosed. The present technology 
also provides for production of high quality cardiac cells from human 
embryonic and induced pluripotent stem cells in chemically defined 
medium conditions. Human pluripotent stem cells, including human 
embryonic stem cells and human induced pluripotent stem cells, can be 
propagated indefinitely while still retaining the capacity to 
differentiate into all somatic cell types, and are a potentially 
inexhaustible supply of human cells. The capacity to sustain survival 
at high density is critical for maintaining consistent stem cell 
cultures and avoiding the development of abnormal stem cells, and for 
proper stem cell differentiation. Also, it is essential to have high 
quality stem cells for all personalized cellular therapies. NIH 
investigators developed a low protein medium that supports the 
proliferation and differentiation of stem cells comprising one or more 
of a volume expander, a lipid mix and a growth factor modulator. Also, 
the investigators have used the new medium to produce high quality 
cardiac cells from human embryonic and induced pluripotent stem cells.
    Potential Commercial Applications:
     Improved defined medium to grow, maintain and 
differentiate stem cells.
     This medium can be used to develop culture systems that 
could be used to generate specific cell types for potential clinical 
applications.
    Competitive Advantages: This new medium could significantly improve 
progenitor cell derivation from embryonic stem cells and induced 
pluripotent stem cells and could have great usage in future 
translational applications.
    Development Stage:
     Early-stage
     In vitro data available
     In vivo data available (animal)
    Inventors: Guokai Chen and Yongshun Lin (NHLBI)
    Intellectual Property: HHS Reference No. E-089-2013/0--US 
Provisional Application No. 61/879,840 filed 19 September 2013
    Licensing Contact: Sury Vepa, Ph.D., J.D.; 301-435-5020; 
vepas@mail.nih.gov
    Collaborative Research Opportunity: The National Heart, Lung, and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize Stem Cell Culture Medium. For collaboration 
opportunities, please contact Peg Koelble at koelblep@nhlbi.nih.gov.

    Dated: February 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-03083 Filed 2-12-14; 8:45 am]
BILLING CODE 4140-01-P