Government-Owned Inventions; Availability for Licensing, 57637-57638 [E8-23437]
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Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
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Biol., in press (available online 2008
Sep 16, doi:10.1016/j.jmb.2008.09.008).
Patent Status: U.S. Provisional
Application No. 61/086,027 filed 04
Aug 2008 (HHS Reference No. E–211–
2008/0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Collaborative Research Opportunity:
The Experimental Transplantation and
Immunology Branch, Center for Cancer
Research, National Cancer Institute is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize the
fully human anti-human NKG2D
monoclonal antibody KYK–2.0 IgG1.
Please contact John D. Hewes, Ph.D. at
301–435–3121 or hewesj@mail.nih.gov
for more information.
Methods for the Detection and
Treatment of Lung Cancer
Description of Technology: Lung
cancer is the third most common
malignant disease and the first leading
cause of cancer death in the western
world. Non-small cell lung cancer
(NSCLC) is one of the leading causes of
death accounting for nearly 30% of all
cancer deaths. Despite considerable
research, lung cancer remains difficult
to diagnose and treat effectively. Current
chemotherapeutic regimens provide
poor survival benefits and the unmet
clinical need among lung cancer
patients is very high. The prognosis is
very bleak since most patients are
diagnosed with lung cancer at a late
stage.
The inventors have discovered that
approximately 20% of common adult
NSCLC have an aberrant activation of
CRTC gene members with marked
induction of CRTC regulated genes.
CRTC activation is linked with the loss
of LKB1/STK11 kinases which results in
CRTC underphosphorylation and
enhanced nuclear localization. As the
LKB1/STK11 signaling pathways has
been exploited in potential cancer
therapeutic treatments, this novel
unrecognized consequence the loss of
LKB1/STK11 function associated with
aberrant CRTC activation in cancer
offers new candidate diagnostic and
therapeutic targets for NSCLC.
Applications:
• Novel cancer diagnostics and
therapeutic treatments.
• Method to detect and treat lung
cancer.
Development Status: The technology
is currently in the pre-clinical stage of
development.
Market:
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23:33 Oct 02, 2008
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• Lung cancer is the leading cause of
cancer deaths among both men and
women in the U.S.
• The NSCLC market was estimated
to be worth US$3.7 billion in 2006 and
will increase by 17% by 2012.
Inventors: Frederic Kaye and Amy
Coxon (NCI).
Patent Status: U.S. Provisional
Application No.61/036,830 filed 13 Mar
2008 (HHS Reference No. E–069–2008/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Human Perilipin Proteins
Description of Technology: Perilipins
are important regulators of lipid storage
in fat cells. These proteins stabilize fat
droplets and control their breakdown by
controlling access of lipid-degrading
enzymes. Since these proteins are
central to the storage and breakdown of
body fat it very likely that they are
crucial for the regulation of body
weight. Perilipin expression is elevated
in obese animals and humans.
Mutations in the perilipin gene are
associated with increased risk of obesity
in women. Importantly, when the
perilipin gene is inactivated the obesity
of model mice is reversed. Therefore,
perilipin could be a good candidate for
therapeutic targeting to treat obesity in
humans.
This NIH invention claims DNA
sequences of splice variants that code
for human perilipin protein isoforms
and methods of expressing the
recombinant protein in bacteria or
mammalian cells. It also claims
substantially purified perilipin proteins
and methods for detecting their
presence in a biological sample.
Applications:
• Drug development for obesity.
• Diagnostics for detection of
perilipins.
• Antigens for antibody production.
• Markers for identifying true
adipocytes.
Advantages:
• Cloned DNA sequences ready for
protein expression.
• Isoforms allow greater flexibility in
designing therapeutics.
Development Status: Pre-clinical.
Inventors: Constantine Londos,
Andrew S. Greenberg, Alan R. Kimmel,
John J. Egan (NIDDK).
Related Publication: AS Greenberg et
al. Perilipin, a major hormonally
regulated adipocyte-specific
phosphoprotein associated with the
periphery of lipid storage droplets. J
Biol Chem. 1991 Jun 15;266(17):11341–
11346.
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57637
Patent Status:
• U.S. Patent No. 6,074,842 issued 13
Jun 2000 (HHS Reference No. E–111–
1991/0–US–03).
• U.S. Patent No. 5,585,462 issued 17
Dec 1996 (HHS Reference No. E–111–
1991/1–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Surekha Vathyam,
PhD; 301–435–4076;
vathyams@mail.nih.gov.
Dated: September 29, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–23436 Filed 10–2–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
ADDRESSES: 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.
Murine Monoclonal Antibodies
Effective To Treat Respiratory
Syncytial Virus
Description of Technology: Available
for licensing through a Biological
Materials License Agreement are the
murine MAbs described in Beeler et al,
‘‘Neutralization epitopes of the F
glycoprotein of respiratory syncytial
virus: effect of mutation upon fusion
function,’’ J Virol. 1989 Jul;63(7):2941–
E:\FR\FM\03OCN1.SGM
03OCN1
57638
Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
2950. The MAbs that are available for
licensing are the following: 1129, 1153,
1142, 1200, 1214, 1237, 1112, 1269, and
1243. One of these MAbs, 1129, is the
basis for a humanized murine MAb (see
U.S. Patent 5,824,307 to humanized
1129 owned by MedImmune, Inc.),
recently approved for marketing in the
United States. MAbs in the panel
reported by Beeler et al. have been
shown to be effective therapeutically
when administered into the lungs of
cotton rats by small-particle aerosol.
Among these MAbs several exhibited a
high affinity (approximately 109M-1) for
the RSV F glycoprotein and are directed
at epitopes encompassing amino acid
262, 272, 275, 276 or 389. These
epitopes are separate, nonoverlapping
and distinct from the epitope recognized
by the human Fab of U.S. Patent
5,762,905 owned by The Scripps
Research Institute.
Applications: Research and drug
development for treatment of respiratory
syncytial virus.
Inventors: Robert M. Chanock, Brian
R. Murphy, Judith A. Beeler, and
Kathleen L. van Wyke Coelingh (NIAID).
Patent Status: HHS Reference No. B–
056–1994/1—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for nonexclusive licensing under a Biological
Materials License Agreement.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Neutralizing Monoclonal Antibodies to
Respiratory Syncytial Virus
Description of Technology:
Respiratory syncytial virus (RSV) is the
most common cause of bronchiolitis and
pneumonia among infants and children
under 1 year of age. Illness begins most
frequently with fever, runny nose,
cough, and sometimes wheezing. During
their first RSV infection, between 25%
and 40% of infants and young children
have signs or symptoms of bronchiolitis
or pneumonia, and 0.5% to 2% require
hospitalization. Most children recover
from illness in 8 to 15 days. The
majority of children hospitalized for
RSV infection are under 6 months of
age. RSV also causes repeated infections
throughout life, usually associated with
moderate-to-severe cold-like symptoms;
however, severe lower respiratory tract
disease may occur at any age, especially
among the elderly or among those with
compromised cardiac, pulmonary, or
immune systems.
This invention is a human
monoclonal antibody fragment (Fab)
discovered utilizing phage display
technology. The neutralizing
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23:33 Oct 02, 2008
Jkt 217001
monoclonal antibody was isolated and
its binding site was identified. Fab F2–
5 is a broadly reactive fusion (F)
protein-specific recombinant Fab
generated by antigen selection from a
random combinatorial library displayed
on the surface of filamentous phage. In
an in vitro plaque-reduction test, the
Fab RSVF2–5 neutralized the infectivity
of a variety of field isolates representing
viruses of both RSV subgroups A and B.
The Fab recognized an antigenic
determinant that differed from the only
other human anti-F monoclonal
antibody (RSV Fab 19) described thus
far. A single dose of 4.0 mg of Fab
RSVF2–5/kg of body weight
administered by inhalation was
sufficient to achieve a 2000-fold
reduction in pulmonary virus titer in
RSV-infected mice. The antigen-binding
domain of Fab RSVF2–5 offers promise
as part of a prophylactic regimen for
RSV infection in humans.
Application: Respiratory Syncytial
Virus prophylaxis/therapeutic.
Development Stage: The antibodies
have been synthesized and preclinical
studies have been performed.
Inventors: Brian Murphy (NIAID),
Robert Chanock (NIAID), James Crowe
(NIAID), et al.
Publication: JE Crowe et al. Isolation
of a second recombinant human
respiratory syncytial virus monoclonal
antibody fragment (Fab RSVF2–5) that
exhibits therapeutic efficacy in vivo. J
Infect Dis. 1998 Apr;177(4):1073–1076.
Patent Status: HHS Reference No. E–
001–1996/0—U.S. and Foreign Rights
Available.
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Human Neutralizing Monoclonal
Antibodies to Respiratory Syncytial
Virus and Human Neutralizing
Antibodies to Respiratory Syncytial
Virus
Description of Technology: This
invention is a human monoclonal
antibody fragment (Fab) discovered
utilizing phage display technology. It is
described in Crowe et al. , Proc Natl
Acad Sci USA. 1994 Feb 15;91(4):1386–
1390 and Barbas et al. , Proc Natl Acad
Sci USA. 1992 Nov 1;89(21):10164–
10168. This MAb binds an epitope on
the RSV F glycoprotein at amino acid
266 with an affinity of approximately
109M-1. This MAb neutralized each of
10 subgroup A and 9 subgroup B RSV
strains with high efficiency. It was
effective in reducing the amount of RSV
in lungs of RSV-infected cotton rats 24
hours after treatment, and successive
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
treatments caused an even greater
reduction in the amount of RSV
detected.
Applications: Research and drug
development for treatment of respiratory
syncytial virus.
Inventors: Robert M. Chanock
(NIAID), Brian R. Murphy (NIAID),
James E. Crowe Jr. (NIAID), et al.
Patent Status: U.S. Patent 5,762,905
issued 09 Jun 1998 (HHS Reference No.
E–032–1993/1–US–01); U.S. Patent
6,685,942 issued 03 Feb 2004 (HHS
Reference No. E–032–1993/1–US–02);
U.S. Patent Application No. 10/768,952
filed 29 Jan 2004 (HHS Reference No. E–
032–1993/1–US–03).
Licensing Status: Available for nonexclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Dated: September 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–23437 Filed 10–2–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Early
Diagnosis Using Nanotechnology-Based
Imaging and Sensing.
Date: October 23, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6116
Executive Boulevard, Room 406, Rockville,
MD 20852, (Telephone Conference Call).
Contact Person: Joyce C. Pegues, PhD,
Scientific Review Officer, Special Review
E:\FR\FM\03OCN1.SGM
03OCN1
Agencies
[Federal Register Volume 73, Number 193 (Friday, October 3, 2008)]
[Notices]
[Pages 57637-57638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23437]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, 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. 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.
ADDRESSES: 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.
Murine Monoclonal Antibodies Effective To Treat Respiratory Syncytial
Virus
Description of Technology: Available for licensing through a
Biological Materials License Agreement are the murine MAbs described in
Beeler et al, ``Neutralization epitopes of the F glycoprotein of
respiratory syncytial virus: effect of mutation upon fusion function,''
J Virol. 1989 Jul;63(7):2941-
[[Page 57638]]
2950. The MAbs that are available for licensing are the following:
1129, 1153, 1142, 1200, 1214, 1237, 1112, 1269, and 1243. One of these
MAbs, 1129, is the basis for a humanized murine MAb (see U.S. Patent
5,824,307 to humanized 1129 owned by MedImmune, Inc.), recently
approved for marketing in the United States. MAbs in the panel reported
by Beeler et al. have been shown to be effective therapeutically when
administered into the lungs of cotton rats by small-particle aerosol.
Among these MAbs several exhibited a high affinity (approximately
10\9\M-1) for the RSV F glycoprotein and are directed at
epitopes encompassing amino acid 262, 272, 275, 276 or 389. These
epitopes are separate, nonoverlapping and distinct from the epitope
recognized by the human Fab of U.S. Patent 5,762,905 owned by The
Scripps Research Institute.
Applications: Research and drug development for treatment of
respiratory syncytial virus.
Inventors: Robert M. Chanock, Brian R. Murphy, Judith A. Beeler,
and Kathleen L. van Wyke Coelingh (NIAID).
Patent Status: HHS Reference No. B-056-1994/1--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Status: Available for non-exclusive licensing under a
Biological Materials License Agreement.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus
Description of Technology: Respiratory syncytial virus (RSV) is the
most common cause of bronchiolitis and pneumonia among infants and
children under 1 year of age. Illness begins most frequently with
fever, runny nose, cough, and sometimes wheezing. During their first
RSV infection, between 25% and 40% of infants and young children have
signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% require
hospitalization. Most children recover from illness in 8 to 15 days.
The majority of children hospitalized for RSV infection are under 6
months of age. RSV also causes repeated infections throughout life,
usually associated with moderate-to-severe cold-like symptoms; however,
severe lower respiratory tract disease may occur at any age, especially
among the elderly or among those with compromised cardiac, pulmonary,
or immune systems.
This invention is a human monoclonal antibody fragment (Fab)
discovered utilizing phage display technology. The neutralizing
monoclonal antibody was isolated and its binding site was identified.
Fab F2-5 is a broadly reactive fusion (F) protein-specific recombinant
Fab generated by antigen selection from a random combinatorial library
displayed on the surface of filamentous phage. In an in vitro plaque-
reduction test, the Fab RSVF2-5 neutralized the infectivity of a
variety of field isolates representing viruses of both RSV subgroups A
and B. The Fab recognized an antigenic determinant that differed from
the only other human anti-F monoclonal antibody (RSV Fab 19) described
thus far. A single dose of 4.0 mg of Fab RSVF2-5/kg of body weight
administered by inhalation was sufficient to achieve a 2000-fold
reduction in pulmonary virus titer in RSV-infected mice. The antigen-
binding domain of Fab RSVF2-5 offers promise as part of a prophylactic
regimen for RSV infection in humans.
Application: Respiratory Syncytial Virus prophylaxis/therapeutic.
Development Stage: The antibodies have been synthesized and
preclinical studies have been performed.
Inventors: Brian Murphy (NIAID), Robert Chanock (NIAID), James
Crowe (NIAID), et al.
Publication: JE Crowe et al. Isolation of a second recombinant
human respiratory syncytial virus monoclonal antibody fragment (Fab
RSVF2-5) that exhibits therapeutic efficacy in vivo. J Infect Dis. 1998
Apr;177(4):1073-1076.
Patent Status: HHS Reference No. E-001-1996/0--U.S. and Foreign
Rights Available.
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Human Neutralizing Monoclonal Antibodies to Respiratory Syncytial Virus
and Human Neutralizing Antibodies to Respiratory Syncytial Virus
Description of Technology: This invention is a human monoclonal
antibody fragment (Fab) discovered utilizing phage display technology.
It is described in Crowe et al. , Proc Natl Acad Sci USA. 1994 Feb
15;91(4):1386-1390 and Barbas et al. , Proc Natl Acad Sci USA. 1992 Nov
1;89(21):10164-10168. This MAb binds an epitope on the RSV F
glycoprotein at amino acid 266 with an affinity of approximately
10\9\M-1. This MAb neutralized each of 10 subgroup A and 9
subgroup B RSV strains with high efficiency. It was effective in
reducing the amount of RSV in lungs of RSV-infected cotton rats 24
hours after treatment, and successive treatments caused an even greater
reduction in the amount of RSV detected.
Applications: Research and drug development for treatment of
respiratory syncytial virus.
Inventors: Robert M. Chanock (NIAID), Brian R. Murphy (NIAID),
James E. Crowe Jr. (NIAID), et al.
Patent Status: U.S. Patent 5,762,905 issued 09 Jun 1998 (HHS
Reference No. E-032-1993/1-US-01); U.S. Patent 6,685,942 issued 03 Feb
2004 (HHS Reference No. E-032-1993/1-US-02); U.S. Patent Application
No. 10/768,952 filed 29 Jan 2004 (HHS Reference No. E-032-1993/1-US-
03).
Licensing Status: Available for non-exclusive licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646;
soukasp@mail.nih.gov.
Dated: September 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-23437 Filed 10-2-08; 8:45 am]
BILLING CODE 4140-01-P