National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings, 52698-52699 [2016-18863]
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52698
Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development 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 and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
Drive, Mail Stop 9702, Rockville, MD
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Vaccines for HIV.
Description of Technology: Although
the development of an effective HIV
vaccine has been an ongoing area of
research, the high variability in HIV–1
virus strains has represented a major
challenge in successful development.
Ideally, an effective candidate vaccine
would provide protection against the
majority of clades of HIV. Two major
challenges are immunodominance and
sequence diversity. One strategy for
overcoming these two issues is to
identify the conserved regions of the
virus and exploit them for use in a
targeted therapy.
Researchers at the National Cancer
Institute’s Vaccine Branch used
conserved elements (CEs) of the
polypeptides Gag and Env as
immunogenic compositions to induce
an immune response to HIV–1 envelope
polypeptides and Gag polypeptides.
conserved elements (CEs) of the
polypeptides Gag and Env as
immunogenic compositions to induce
an immune response to HIV–1 envelope
polypeptides and Gag polypeptides.
This invention is based, in part, on the
discovery that administration of one or
more polypeptides comprising CEs,
separated by linkers and collinearly
arranged, of HIV Env or Gag CE proteins
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can provide a robust immune response
compared to administration of a fulllength Env or Gag protein. The Env-CE
DNA vaccines were tested in a rhesus
macaque model and were able to induce
a cellular and humoral immune
response in this model whereas
vaccination with the full length DNA
did not produce the same effect.
A robust increase in immunity was
observed when rhesus macaques were
subjected to a prime-boost protocol.
First, rhesus macaques were primed
with Env-CE DNA and boosted with full
length Env resulting in an observed
increase in both the cellular and
humoral responses. A further increase
in immune response was observed from
priming with CE and boosting with a
combination of CE and full length DNA
resulting in a significantly improved
breadth of immune responses. These
improved protocols may help solve the
immunodominance problem observed
in current protocols. This is considered
a major obstacle for HIV vaccine
development. The CE vaccines
described by this invention have
potential for use as prophylactic and
therapeutic HIV vaccines.
Potential Commercial Applications:
• HIV vaccines
Value Proposition:
• Addresses two key hurdles faced by
current HIV vaccines: sequence
diversity of HIV and
immunodominance.
• Induces cross-clade specific
immune response.
• The prime-boost immunization
regimen is not limited to HIV, but can
be employed to improve the induction
of immune responses to any
subdominant epitopes (cellular or
humoral) to increase breadth, magnitude
and quality of the immune response.
Development Stage: Pre-clinical (in
vivo validation).
Inventor(s): George Pavlakis, Barbara
Felber, Antonio Valentin, James
Mullins.
Intellectual Property: HHS Reference
#E–087–2015/0–US–01, corresponding
to U.S. Provisional Patent App. #62/
161,123, filed on May 13, 2015, entitled:
HIV Env Conserved Element DNA
Vaccine.
HHS Reference #E–009–2016/0–US–
01, corresponding to U.S. Provisional
Patent App. #62/241,599, filed on
October 14, 2015, entitled: Prime-Boost
combination vaccine to Expand Breadth
of Immunological Response.
HHS Reference #E–087–2015/0–PCT–
02; corresponding to International
Patent App. #PCT/US2016/032317; filed
on May 13, 2016, entitled: Methods and
Compositions for inducing an immune
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response using Conserved Element
Constructs.
Publications
• Kulkarni, V. et al. PLoS One;9:e86254.
2014. https://journals.plos.org/plosone/
article?id=10.1371/journal.pone.0086254
• Kulkarni, V. et al. PLos One Oct
22;9(10):e111085. doi: 10.1371/
journal.pone.0111085. eCollection, 2014.
https://journals.plos.org/plosone/
article?id=10.1371/journal.pone.0111085
Related Technologies: HHS Reference
#E–132–2012/0 Method of Altering the
Immunodominance Hierarchy of HIV
Gag by DNA Vaccine Expressing
Conserved Regions.
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: August 2, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–18861 Filed 8–8–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Review of Late Arriving K
Mechanism Grant Applications.
Date: August 17, 2016.
Time: 8:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices
Contact Person: William C. Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/ NIH/DHHS, Neuroscience Center,
6001 Executive Blvd., Suite 3204, MSC 9529,
Bethesda, MD 20892–9529, 301–496–0660,
Benzingw@mail.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.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Clinician Training Program
R25 Application Review.
Date: August 17, 2016.
Time: 2:00 p.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: William C. Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS, Neuroscience Center,
6001 Executive Blvd, Suite MSC 9529,
Bethesda, MD 20892–9529, 301–496–0660,
Benzingw@mail.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.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Biorepository Resource
Access Committee (BRAC) X01 Meeting.
Date: August 18, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Joel A. Sayoff, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS, Neuroscience Center,
6001 Executive Blvd., Suite 3204, MSC 9529,
Bethesda, MD 20892–9529, 301–496–9223,
joel.saydoff@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
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: August 3, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–18863 Filed 8–8–16; 8:45 am]
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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
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development 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 and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD, 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
Drive, Mail Stop 9702, Rockville, MD,
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Methods of
Treating or Preventing Demyelination
Using Thrombin Inhibitors and Methods
of Detecting Demyelination Using
Neurofascin 155.
Description of Technology:
Neurofascin 155 is a cell adhesion
molecule that attaches myelin to
axolemma. Contactin-associated protein
(Caspr) is a major component of the
perinodes. Perinodal astrocytes regulate
nodal structure and myelin thickness by
regulating thrombin-dependent cleavage
of axo-glial junction attaching the
outermost paranodal loops of myelin to
the axon membrane. Agents which
inhibit the cleavage of Neurofascin 155
or the cleavage of Caspr1 stabilize the
node and may impede the
immunological attack of myelin where
the paranodes are attached to the axon.
SUMMARY:
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52699
The technology is directed to methods
of treating diseases characterized by
demyelination (such as Multiple
sclerosis), white matter injury, or
conditions associated with myelin
remodeling by administering an agent
that inhibits cleavage of Neurofascin
155 or Caspr1. The agent could be a
thrombin inhibitor, an agent that
inhibits thrombin expression, an antithrombin antibody that specifically
inhibits thrombin mediated cleavage of
Neurofascin 155, a mutated version or
fragment of Neurofascin 155 or Caspr1,
antibodies to Neurofascin 155 or Caspr1.
The technology also includes methods
of detecting remodeling of myelin by
detecting changes in levels of
Neurofascin 125 and Neurofascin 30 in
a biological sample, such as central
spinal fluid or blood.
Potential Commercial Applications:
Treatment of demyelinating diseases,
such as Multiple sclerosis.
Treatment of diseases characterized
by white matter injury or myelin
remodeling.
Monitoring the amount of or rate of
remodeling of myelin to determine the
efficacy of agents used demyelinating
diseases.
Value Proposition: Agents which
inhibit cleavage of Neurofascin 155 or
Caspr1 or inhibit thrombin activity are
a novel approach to treating
demyelinating diseases or diseases
characterized by white matter injury.
The methods of detecting
modification in the amount or rate of
remodeling of myelin can be used to
determine the efficacy of treatments of
neurological disorders and are less
expensive than other methods currently
used.
Development Stage: Pre-clinical (in
vivo validation).
Inventor(s): R. Douglas Fields https://
science.nichd.nih.gov/confluence/
display/snsdp/Home.
Intellectual Property: HHS Reference
No. E–151–2015/0–PCT–02.
PCT application, PCT/US2016/
027776, filed April 15, 2016 entitled
‘‘Methods of Treating or Preventing
Demyelination Using Thrombin
Inhibitors and Methods of Detecting
Demyelination Using Neurofascin 155’’.
Publications: 1. In preparation.
Collaboration Opportunity:
Researchers at the Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(‘‘NICHD’’), seek CRADA partner or
collaboration for development of agents
to treat multiple sclerosis or other
conditions associated with myelin
remodeling by administering an agent
that inhibits cleavage of Neurofascin
155 or Caspr1. The agent could be a
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Agencies
[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52698-52699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18863]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Neurological Disorders and Stroke; 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: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel; Review of Late Arriving K
Mechanism Grant Applications.
Date: August 17, 2016.
Time: 8:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
[[Page 52699]]
Contact Person: William C. Benzing, Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/ NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite
3204, MSC 9529, Bethesda, MD 20892-9529, 301-496-0660,
Benzingw@mail.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.
Name of Committee: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel; Clinician Training Program R25
Application Review.
Date: August 17, 2016.
Time: 2:00 p.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: William C. Benzing, Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd, Suite MSC
9529, Bethesda, MD 20892-9529, 301-496-0660, Benzingw@mail.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.
Name of Committee: National Institute of Neurological Disorders
and Stroke Special Emphasis Panel; Biorepository Resource Access
Committee (BRAC) X01 Meeting.
Date: August 18, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Joel A. Sayoff, Ph.D., Scientific Review
Officer, Scientific Review Branch, Division of Extramural Research,
NINDS/NIH/DHHS, Neuroscience Center, 6001 Executive Blvd., Suite
3204, MSC 9529, Bethesda, MD 20892-9529, 301-496-9223,
joel.saydoff@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 Program Nos. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS)
Dated: August 3, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-18863 Filed 8-8-16; 8:45 am]
BILLING CODE 4140-01-P