[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10129-10130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03779]


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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. 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.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

HbF Induction Therapy for Sickle Cell Disease and Thalassemias

    Description of Technology: Sickle cell disease and thalassemia are 
hereditary disorders marked by the disruption in the pathways 
responsible for carrying oxygen to red blood cells. Symptoms associated 
with these disorders include anemia, jaundice, and severe pain. It has 
been shown that mutations during the development of fetal to adult 
hemoglobin can contribute to a delay in red blood cell maturity 
underlying sickle cell disease. As a result, there has been an 
increased focus on treatments that promote the induction of fetal 
hemoglobin (HbF) to improve clinical symptoms and ameliorate the 
severity of the diseases. Researchers at the National Institute of 
Diabetes and Digestive and Kidney Diseases have identified methods of 
increasing fetal hemoglobin by increasing the expression of Lin28 or 
decreased expression of let-7 micro-RNAs. The lead inventor and 
colleagues have developed novel lentiviral expression vectors 
containing hemoglobin regulators under the control of erythroid-
specific promoters that can be used to increase Hbf expression without 
affecting the maturity of red blood cells. In addition, they have 
found, through the use of tough decoy inhibition of Let-7 micro-RNAs, a 
selection of Let-7 genes with greater involvement in HbF expression. 
This technology could lead to development of novel HbF induction 
therapies that reactivate and reduce the aberrant pathologies 
associated with human sickle-cell anemia and beta thalassemia.
    Potential Commercial Applications:
     Ex vivo and in vivo therapeutics for treatment of sickle-
cell anemia and beta thalassemias.
     Potential use in combination with other transduction 
methods for unique therapeutic strategies.
    Competitive Advantages:
     Reduced production of symptom-associated adult hemoglobin.
     Lin28 overexpression at defined stage of hematopoietic 
cell development.
     Therapeutic increases in patient HbF expression at lower 
viral titers than current direct transduction methods.
     Improved safety and reduced toxicity as a result of 
erythroid-specific expression.
    Development Stage:
     Early-stage
     In vitro data available
     In vivo data available (animal)
    Inventors: Jeffery L. Miller, Yuanwei T. Lee, Jaira F. de 
Vasconcellos, Colleen K. Byrnes (all of NIDDK)
    Intellectual Property: HHS Reference No. E-249-2014/0--US 
Provisional Application No. 62/046,247 filed September 5, 2014
    Related Technology: HHS Reference No. E-456-2013/2--PCT Application 
No. PCT/US2013/067811 filed October 31, 2013, which published as WO 
2014/200557 on December 18, 2014
    Licensing Contact: Vince Contreras, Ph.D.; 301-435-4711; 
[email protected]
    Collaborative Research Opportunity: The National Institute of 
Diabetes and Digestive and Kidney Diseases is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize this technology. 
For collaboration opportunities, please contact Marguerite J. Miller at 
[email protected] or 301-496-9003.

T Cell-Based Adoptive Transfer Immunotherapy for Polyomavirus-
Associated Pathologies

    Description of Technology: Available for licensing are methods to 
generate T cells responsive to multiple polyomaviruses. The resulting T 
cell populations could be useful in treating immunosuppressed 
individuals with polyomavirus infections or polyomavirus-associated 
pathologies such as Merkel cell carcinoma (MCC), polyomavirus-
associated nephropathy (PVAN), hemorrhagic cystitis,

[[Page 10130]]

progressive multifocal leukoencephalopathy (PML), and trichodysplasia 
spinulosa (TS). The methods could also be used to restore polyomavirus-
specific immunity in immunocompromised individuals.
    Potential Commercial Applications: Immunotherapy for 
immunosuppressed individuals with polyomavirus-associated pathologies.
    Competitive Advantages: Methods allow development of polyomavirus 
antigen-specific T cells.
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: John A. Barrett (NHLBI), Dhanalakshmi Chinnasamy 
(NHLBI), Pawel J. Muranski (NHLBI), Christopher B. Buck (NCI)
    Intellectual Property: HHS Reference No. E-166-2014/0--US 
Application No. 62/075,726 filed November 5, 2014
    Related Technologies:
     HHS Reference No. E-168-2011
     HHS Reference No. E-549-2013
    Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560; 
[email protected]
    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 methods to generate T cells responsive to 
multiple polyomaviruses. For collaboration opportunities, please 
contact Dr. Vincent Kolesnitchenko at [email protected].

\89\Zr-Oxine Complex for In Vivo PET Imaging of Labelled Cells and 
Associated Methods

    Description of Technology: This technology relates to a Zirconium-
89 (\89\Zr)-oxine complex for cell labeling, tracking of labeled cells 
by whole-body positron emission tomography/computed tomography (PET/CT) 
imaging, and associated methods. A long half-life of \89\Zr (78.4 
hours), high sensitivity of PET and absence of background signal in the 
recipient enable tracking cells over a week using low levels of 
labeling radioactivity, without causing cellular toxicity. The \89\Zr-
oxine complex is synthesized quickly by mixing components at room 
temperature and produces high yields. Cell labeling is achieved by a 
short, room temperature incubation. The \89\Zr-oxine complex is capable 
of labeling a wide range of cell types of therapeutic or pathogenic 
relevance (natural, disease, engineered cells), independent of factors 
such as cell cycle or receptor expression. The label is retained during 
cell division. \89\Zr-oxine labeled cells can also be easily cross 
labeled (for example, optically or magnetically) for multi-modality 
imaging and analysis. Labeled cell migration and kinetics can be 
analyzed and quantified in vivo over a week, improving research 
strategies and ability to develop and improve cell therapies and 
diagnostics.
    Potential Commercial Applications: Cell therapies and diagnostics.
    Competitive Advantages: Simple preparation, broadly applicable cell 
label, high resolution imaging and monitoring over period of a week, 
low toxicity, easily combined with labeling technologies and cell 
therapies.
    Development Stage: In vivo data available (animal).
    Inventors: Noriko Sato (NCI), Haitao Wu (NHLBI), Gary L. Griffiths 
(NCI), Peter L. Choyke (NCI)
    Publications:
    1. Sato N, et al. Generation and use of long-lasting cell labeling 
agent for positron emission tomography (PET) imaging. J Nucl Med. May 
2014; 55 (Supplement 1):273.
    2. Sato N, et al. \89\Zr-oxine complex positron emission tomography 
(PET) cell imaging for monitoring cell-based therapies. Radiology, 
2015, In press.
    Intellectual Property: HHS Reference No. E-080-2014/0--US Patent 
Application No. 61/973,706 filed April 1, 2014
    Licensing Contact: Edward (Tedd) Fenn; 424-297-0336; 
[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 
cell labeling, cell tracking, cell trafficking, cell-based therapy, PET 
imaging. For collaboration opportunities, please contact John D. Hewes, 
Ph.D. at [email protected] or 240-276-5515.

    Dated: February 18, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-03779 Filed 2-24-15; 8:45 am]
BILLING CODE 4140-01-P