[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Pages 39787-39789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16838]


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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

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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.

Method of Treating Fumarate Hydratase-Deficient Kidney Cancer

    Description of Technology: Patients having germline fumarate 
hydratase (``FH'') gene mutation are predisposed to develop aggressive 
kidney cancer with few treatment options and poor therapeutic outcomes. 
NCI scientists have identified a tyrosine kinase inhibitor vandetanib 
that is highly cytotoxic to kidney cancer cells both in vitro and in 
vivo. C-Abl activity is upregulated in FH-deficient kidney tumors and 
vandetanib efficacy is a direct consequence of c-Abl inhibition. It was 
also found that combining metformin enhanced the cytotoxic effect of 
vandetanib by inhibiting NRF2 transcriptional activity in a SIRT1-
dependent manner. Thus dual inhibition of c-Abl and NRF2 activity with 
vandetanib and metformin is a novel therapeutic approach to target 
glycolytically dependent, oxidatively stressed tumors.
    Potential Commercial Applications: Therapies for treating FH-
deficient kidney cancer and glycolytically dependent, oxidatively 
stressed tumors.
    Competitive Advantages:
     Specificity of mode of action may reduce potential side-
effects.
     Novel mode of action may increase market competition.
     No effective therapy is currently available for patients 
with advanced FH-deficient kidney cancer.
    Development Stage:
     In vitro data available.
     In vivo data available (animal).
    Inventors: William Marston Linehan (NCI), et al.
    Publication: Sourbier C, et al. Targeting ABL1-mediated oxidative 
stress adaptation in fumarate hydratase-deficient cancer. Cancer Cell. 
2014 Dec 8;26(6):840-50. [PMID 25490448]
    Intellectual Property: HHS Reference No. E-104-2014/0--
     US Patent Application No. 62/003,319 filed May 27, 2014.
     PCT/US2015/03267 filed May 27, 2015.
    Licensing Contact: Whitney Hastings, Ph.D.; 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 combination of Vandetanib and Metformin to treat fumarate 
hydratase-deficient cancer. For collaboration opportunities, please 
contact Michael Pollack, Ph.D. at [email protected].

Therapeutic and Prophylactic Anti-Influenza Virus Neuraminidase 1 (N1) 
Antibody (CD6) With a Novel Epitope That Spans Neuramindase (NA) Dimers

    Description of Technology: Influenza virus neuramindase (NA) 
protein is a surface protein that plays an essential role in virus 
replication. Drugs and antibodies that block NA function can reduce 
both the symptoms and the length of illness; however, variants of 
influenza virus are resistant to NA inhibitors. The neuramindase 1 (N1) 
subtype of NA is important because it is found in the two pandemic H1N1 
influenza virus strains (1918 Spanish flu and 2009 swine flu) and the 
H5N1 avian influenza virus. Anti-neuramindase antibody CD6 is a novel 
antibody that spans a conserved 30 amino acid epitope across the 
lateral face of a neuramindase (NA) dimer.
    The subject technology may offer an alternative to therapeutic NA 
inhibitors currently available. CD6 is a potent monoclonal antibody 
against N1 subtypes of NA that inhibits the enzymatic activity of the 
NA protein, including NA variants resistant to NA inhibitors. In a 
murine model of infection, a single dose of antibody was protective 
against lethal challenge with H1N1 influenza virus. The CD6 antibody 
can potentially be used in combination with other antibodies in an 
antibody ``cocktail'' or in conjunction with other therapeutic agents. 
Additionally, this unique anti-NA antibody may be useful in combination 
with known neutralizing anti-hemagglutinin (HA) antibodies.
    Potential Commercial Applications:
     Prophylactic and therapeutic against influenza virus 
infections.
     Diagnostic tests for influenza virus infections.
     Reagent to measure the potency of H1N1 NA in influenza 
virus vaccines.
    Competitive Advantages:
     Monoclonal antibody demonstrated to be effective against 
circulating H1N1 influenza viruses.
     Monoclonal antibody binds a novel, conserved epitope 
spanning NA dimers.
     Monoclonal antibody is well-suited for an antibody 
cocktail that includes anti-HA antibodies.
    Development Stage:
     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Hongquan Wan (FDA), Maryna Eichelberger (FDA), Hua Yang 
(CDC), James Stevens (CDC), David Shore (CDC), Rebecca Garten (CDC).
    Publication: Wan H, et al. Structural characterization of a 
protective epitope spanning A(H1N1)pdm09 influenza virus neuraminidase 
monomers. Nat Commun. 2015 Feb 10;6:6114. [PMID 25668439].
    Intellectual Property: HHS Reference No. E-005-2015/0--US 
Provisional Patent Application No. 62/088,388 filed December 5, 2014.
    Licensing Contact: Steven M. Ferguson; 301-435-5561; 
[email protected].
    Collaborative Research Opportunity: The U.S. Food and Drug 
Administration 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 Bill Ronnenberg at 
[email protected] or 240-402-4561.

Confocal Laser Device and Method for Evaluating the Optical Properties 
of Intraocular Lenses (IOLs) Including Toric IOLs

    Description of Technology: This innovative technology includes a 
confocal laser device and methodologies to evaluate the optical 
properties of spherical and toric Intraocular Lenses (IOLs). Spherical 
and toric IOLs are implanted in the eye to treat cataracts and other 
conditions in order to correct vision after surgery. Toric IOLs, in 
addition to correcting spherical aberrations of the eye, correct 
asymmetrical aberrations of the eye such as astigmatism.
    This technology includes the confocal laser device and methodology 
for assessing spherical IOLs with an integrated component for assessing 
toric IOLs. The IOL market is growing steadily and IOL technology is 
continually improving to correct complex vision errors. It is estimated 
that 3 million IOLs are implanted annually in the U.S. and 19.7 million 
worldwide. This device can be used to precisely assess IOL key 
properties such as dioptric power, cylinder power, optical plane 
orthogonality and IOL markings used for IOL positioning in the eye 
during surgery. Thus, this new technology provides a simple, 
noninvasive, accurate and objective methodology to evaluate IOL 
characteristics with higher accuracy and repeatability in wider power 
ranges compared to the conventional test

[[Page 39789]]

methods. These IOL test capabilities can improve the safety and 
efficacy of IOL implants and ultimately lead to better cataract surgery 
success rates.
    Potential Commercial Applications:
     Development and implementation of novel test devices and 
independent methodologies for precise evaluation and validation of 
critical IOL characteristics.
     Development and evaluation of novel IOL designs.
    Competitive Advantages:
     Higher accuracy.
     Higher repeatability.
     Larger range of positive and negative IOL dioptric power 
measurement.
    Development Stage:
     In vitro data available.
     In situ data available (on-site).
     Prototype.
    Inventors: Ilko Ilev, Bennett Walker, Robert James, and Don 
Calogero (all of the FDA).
    Publications:
    1. Walker BN, et al. Assessing the effect of laser beam width on 
quantitative evaluation of optical properties of intraocular lens 
implants. J Biomed Opt. 2014 May;19(5):055004. [PMID 24817618]
    2. Walker BN, et al. Impact of environmental temperature on optical 
power properties of intraocular lenses. Appl Opt. 2014 Jan 
20;53(3):453-7. [PMID 24514132]
    3. Hoffer KJ, et al. Testing the dioptric power accuracy of exact-
power-labeled intraocular lenses. J Cataract Refract Surg. 2009 
Nov;35(11):1995-9. [PMID 19878834]
    4. Ilev IK. A simple confocal fibre-optic laser method for 
intraocular lens power measurement. Eye (Lond). 2007 Jun;21(6):819-23. 
[PMID 16710435]
    Intellectual Property:
     HHS Reference No. E-047-2015/0--US Provisional Application 
No. 62/108,795 filed January 28, 2015.
     HHS Reference No. E-038-2005/0--US Patent No. 8,456,738 
issued June 4, 2013; EP Application 06750250.0.
     HHS Reference No. E-039-2005/0--US Patent No. 7,719,668 
issued May 18, 2010; EP Application 06736741.7.
    Licensing Contact: Steven M. Ferguson; 301-435-5561; 
[email protected].
    Collaborative Research Opportunity: The Food and Drug 
Administration 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 Bill Ronnenberg at 
[email protected] or 240-402-4561.

    Dated: July 6, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-16838 Filed 7-9-15; 8:45 am]
 BILLING CODE 4140-01-P