Government-Owned Inventions; Availability for Licensing, 39787-39789 [2015-16838]
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Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Notices
Rockledge Drive, Room 2200, MSC 7890,
Bethesda, MD 20892, 301 435–2514,
riverase@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
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93.337, 93.393–93.396, 93.837–93.844,
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Institutes of Health, HHS)
Dated: July 2, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–16841 Filed 7–9–15; 8:45 am]
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Pursuant to section 10(d) of the
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amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Opportunities for
Collaborative Research at the NIH Clinical
Center (U01).
Date: August 14, 2015.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Conference Room 3F100, 5601 Fishers Lane,
Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Brenda Lange-Gustafson,
Ph.D., Scientific Review Officer, NIAID/NIH/
DHHS, Scientific Review Program, 5601
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(Catalogue of Federal Domestic Assistance
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and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
VerDate Sep<11>2014
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Dated: July 7, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–16937 Filed 7–9–15; 8:45 am]
Office of the Director; Notice of Charter
Renewal
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amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Diabetes Ancillary
Studies.
Date: July 29, 2015.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
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Conference Call).
Contact Person: Carol J. Goter-Robinson,
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Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: July 6, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–16840 Filed 7–9–15; 8:45 am]
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National Institutes of Health
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
section 102–3.65(a), notice is hereby
given that the Charter for the
Recombinant DNA Advisory Committee,
National Institutes of Health, was
renewed for an additional two-year
period on June 30, 2015.
It is determined that the Recombinant
DNA Advisory Committee, National
Institutes of Health, is in the public
interest in connection with the
performance of duties imposed on the
National Institutes of Health by law, and
that these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
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Dated: July 6, 2015.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–16839 Filed 7–9–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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
SUMMARY:
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Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Notices
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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 SIRT1dependent 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 FHdeficient 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 hydratasedeficient 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; hastingw@
mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute is seeking
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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
pollackm@mail.nih.gov.
Therapeutic and Prophylactic AntiInfluenza 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 antihemagglutinin (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.
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• 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; fergusos@
mail.nih.gov.
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 william.ronnenberg@
fda.hhs.gov 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
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Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Notices
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 fibreoptic 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; fergusos@
mail.nih.gov.
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 william.ronnenberg@
fda.hhs.gov or 240–402–4561.
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Jkt 235001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–EB–
15–003: Pediatric Research using Integrated
Sensor Monitoring Systems (PRISMS):
Informatics Platform Technologies for
Asthma (U54).
Date: July 23, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Peter J Kozel, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
Bethesda, MD 20892, 301–435–1116, kozelp@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cardiovascular Sciences.
Date: July 28–30, 2015.
Time: 8:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Kimm Hamann, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118A,
MSC 7814, Bethesda, MD 20892, 301–435–
5575, hamannkj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Implementation Science.
Date: July 31, 2015.
Time: 12:30 p.m. to 4:00 p.m.
PO 00000
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39789
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jose H Guerrier, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neuropharmacology.
Date: August 3, 2015.
Time: 2:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Richard D Crosland, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7850, Bethesda, MD 20892, 301–435–
1220, crosland@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: August 4–5, 2015.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Kenneth A Roebuck, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–EB–
15–002: PRISMS Sensor Development
Projects for Pediatric Asthma (U01).
Date: August 6, 2015.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Kee Hyang Pyon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5148,
MSC 7806, Bethesda, MD 20892, pyonkh2@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Pregnancy and Neonatology.
Date: August 6, 2015.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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
[[Page 39788]]
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;
hastingw@mail.nih.gov.
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 pollackm@mail.nih.gov.
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;
fergusos@mail.nih.gov.
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
william.ronnenberg@fda.hhs.gov 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
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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;
fergusos@mail.nih.gov.
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
william.ronnenberg@fda.hhs.gov 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
