[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26791-26792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10857]


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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.

Induced Pluripotent Stem Cells Generated Using Lentivirus-Based 
Reprogramming

    Description of Technology: Five human induced pluripotent stem 
cells (iPSC) lines are generated using lentivirus-based reprogramming 
technology. These lines are pluripotent, meaning they have the 
potential to differentiate into all cells in the body, and 
theoretically can proliferate/self-renew indefinitely. The iPSC lines 
are: NC1 (derived from female's fibroblasts), NC2 (derived from 
female's fibroblasts), NC3 (derived from male's HUVECS), NC4 (derived 
from male's fibroblasts) and NC5 (derived from female's fibroblasts). 
Further details of these cells are available upon request. NC1 uses a 
retrovirus delivery system incorporating the following vectors: pMIG-
hKLF4, pMIG-hOCT4, pMIG-hSOX2, and MSCV h c-MYC IRES GFP. NC2-NC5 use 
the hSTEMCCA-loxP lentivirus delivery system (a gift from Dr. Gustavo 
Mostoslavsky). These cell lines will be useful for studies related to 
stem cell biology, understanding diseases, potential cell therapies, 
and small molecule screening.
    Potential Commercial Applications: The iPSCs of this technology are 
useful:
    (a) To study the biology of stem cell development,
    (b) as controls in studies to screen for small molecules to change 
cell fate and/or to alleviate the phenotypes of various diseases, and
    (c) to test different characterization and differentiation assays.
    Competitive Advantages:
     These cells can serve as control cells and, thus, 
significantly reduce the cost of initiating many research projects.
     These cells can be a good source of control cells.
    Development Stage:
     Prototype
     Pilot
     Early-stage
     In vitro data available
    Inventors: Drs. Guibin Chen and Manfred Boehm (NHLBI)
    Intellectual Property: HHS Reference No. E-274-2012/0--Research 
Tools. Patent protection is not being pursued for this technology.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; [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 Induced Pluripotent Stem Cells. For 
collaboration opportunities, please contact Denise Crooks, OTTAD, at 
301-435-0103.

Stapled Peptides for Treatment of Cardiovascular Diseases and 
Inflammation

    Description of Technology: The invention is directed to small 
molecule mimetics of apolipoproteins that have an inter-helical 
hydrocarbon bond, which stabilizes helix formation.
    Apolipoproteins facilitate the transport of lipids and cholesterol 
in the body. Mimetics of apolipoproteins have been used to treat 
cholesterol-related disorders. However, these mimetics are susceptible 
to degradation in biological fluids and as a result, their ability to 
bind cholesterol becomes diminished over time.
    Scientists at NHLBI have devised methods to stabilize and improve 
the performance of apolipoprotein mimetic peptides, using a modified 
hydrocarbon chain (``stapled apolipoproteins''). These stapled 
apolipoproteins are superior to singular apolipoproteins in that they 
are more resistant to enzymatic degradation and efflux a greater amount 
of cellular cholesterol.
    Stapled apolipoproteins can be used in the treatment of 
cardiovascular diseases, particularly for treatment of atherosclerosis.
    Potential Commercial Applications:
     Treatment of inflammation and cardiovascular diseases, 
including hyperlipidemia, atherosclerosis, restenosis, and acute 
coronary syndrome.
     Inclusion in oral, intravenous or transdermal peptide 
formulations.
    Competitive Advantages:
     Stapled apolipoproteins are more resistant to proteolysis 
and display enhanced bioavailability.
     Stapled apolipoproteins are amenable to oral delivery and 
have increased permeability to the blood brain barrier.
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Alan T. Remaley (CC), Marcelo A. Amar (NHLBI), Imoh Z.

[[Page 26792]]

Ikpot (NHLBI), Denis O. Sviridov (NHLBI), David O. Osei-Hwedieh 
(NHLBI), Scott Turner (KineMed)
    Publication: Osei-Hwedieh DO, et al. Apolipoprotein mimetic 
peptides: Mechanisms of action as anti-atherogenic agents. Pharmacol 
Ther. 2011 Apr;130(1):83-91. [PMID 21172387]
    Intellectual Property: HHS Reference No. E-126-2011/0--US 
Application No. 61/480,986 filed 29 April 2011; PCT Application No. 
PCT/US1235870 filed 30 April 2012
    Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; [email protected]
    Collaborative Research Opportunity: The NHLBI Lipoprotein 
Metabolism Section is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize Hydrocarbon-stapled Apolipoprotein Peptide 
Mimetics for the Treatment of Cardiovascular Diseases and Inflammation. 
For collaboration opportunities, please contact Denise Crooks, Ph.D. at 
[email protected].

Parvovirus B19 Vaccine

    Description of Technology: Parvovirus B19 (B19V) infection causes 
fifth disease, a disease characterized by rashes to the face and other 
parts of the body that primarily affects children. However, adults can 
also develop fifth disease and it can lead to more severe conditions. 
Patients that are immunocompromised, such as those who are HIV 
infected, organ transplant recipients, and cancer patients, can be 
particularly susceptible to more severe outcomes from B19V infection. 
Infection can also cause anemia and in pregnant women, it can lead to 
hydrops fetalis.
    The subject technologies are expression vectors for the production 
of B19V VP1 and VP2 capsid proteins. Co-expression of the two proteins 
produce empty virus-like particles (VLPs) that can be used to develop a 
vaccine against parvovirus B19 and a packaging system for infectious 
B19V virus. Different expression vectors have been developed and 
optimized for expression in insects cells and more recently in 
mammalian cell lines such as 293, Cos7, Hela cells and 293T cells.
    Potential Commercial Applications: Vaccine against parvovirus B19V.
    Competitive Advantages: There is currently no B19V vaccine on the 
market.
    Development Stage:
     Early-stage
     Pre-clinical
     Clinical
     In vitro data available
     In vivo data available (animal)
     In vivo data available (human)
    Inventors: Neal S. Young, Takashi Shimada, Sachiko Kajigaya, Ning 
Zhi (NHLBI)
    Publications:
    1. Bernstein DI, et al. Safety and immunogenicity of a candidate 
parvovirus B19 vaccine. Vaccine. 2011 Oct 6;29(43):7357-63. [PMID 
21807052]
    2. Zhi N, et al. Codon optimization of human parvovirus B19 capsid 
genes greatly increases their expression in nonpermissive cells. J 
Virol. 2010 Dec;84(24):13059-62. [PMID 20943969]
    Intellectual Property:
     HHS Reference No. E-286-1988/2--U.S. Patent No. 5,916,563 
issued 29 Jun 1999
     HHS Reference No. E-286-1988/1--U.S. Patent No. 6,001,371 
issued 14 Dec 1999; U.S. Patent No. 6,132,732 issued 17 Oct 2000
     HHS Reference No. E-266-2000/0--U.S. Patent No. 6,558,676 
issued 06 May 2003
     HHS Reference No. E-011-2010/0--International PCT Appl. 
No. PCT/US2011/024199 with national stage filings in the U.S. and 
Europe
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[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 the technology for producing Parvovirus B19 
vaccine. For collaboration opportunities, please contact Cecilia 
Pazman, Ph.D. at [email protected].

     Dated May 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-10857 Filed 5-7-13; 8:45 am]
BILLING CODE 4140-01-P