Government-Owned Inventions; Availability for Licensing, 22742-22743 [2020-08561]
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Federal Register / Vol. 85, No. 79 / Thursday, April 23, 2020 / Notices
Development Stage:
• Pre-clinical.
Inventors: Eric O. Long (NIAID),
Xiaoxuan Zhuang (NIAID).
Publications: Zhuang X and Long
E.O., ‘‘CD28 homolog is a strong
activator of natural killer cells for lysis
of B7H7-positive tumor cells.’’ Cancer
Immunol Res 7(6):939–951. https://
cancerimmunolres.aacrjournals.org/
content/7/6/939.long. April 24, 2019.
Trends Immunol: ‘‘Inhibition-resistant
CARs for NK cell cancer
immunotherapy’’ Trends Immunol
40:1078–1081, December 2019.
Intellectual Property: HHS Reference
No. E–097–2020–0–PCT–01, PCT Patent
Application No. PCT/US2020/024985.
Licensing Contact: To license this
technology, please contact Chris Kornak
at 240–627–3705 or Chris.Kornak@
nih.gov, and reference E–097–2020–0.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases 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 Chris Kornak at 240–627–3705
or Chris.Kornak@nih.gov.
Dated: April 12, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–08562 Filed 4–22–20; 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 invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing 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:
Amy F. Petrik, Ph.D., 240–627–3721;
amy.petrik@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
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19:28 Apr 22, 2020
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obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD, 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows:
Recombinant Prefusion Measles and
Mumps F and F–HN (H) Glycoproteins
for Vaccine Development.
Description of Technology: The
Measles virus (MeV) and Mumps virus
(MuV) are highly contagious
paramyxoviruses that can be transmitted
by respiratory droplets from or on direct
contact with an infected person. The
resulting diseases can lead to serious
complications or death among children.
The existing vaccines for MeV and MuV
are live attenuated virus vaccines which
are administered in two subcutaneous
doses at 1 year of age and as early as one
month later. Two doses of a
combination measles, mumps and
rubella vaccine are 97% effective
against measles and 88% against
mumps. A single dose of a combination
measles, mumps, and rubella vaccine is
93% effective against measles and 78%
effective against mumps.
Despite the effectiveness of the
current licensed vaccines against MeV
and MuV, incidences of both have
increased in recent years. Contributing
factors include reduced vaccination
rates (especially in the U.S) due to
vaccine hesitancy and circulation of
divergent strains against which the
licensed MMR vaccine offers limited
protection.
In the case of MuV, recent studies
have shown that immunity wanes
significantly after the second MMR
vaccination which normally occurs in
childhood. In response to recent
recurring MuV disease outbreaks in the
U.S and Europe, the Advisory
Committee on Immunization Practices is
advising a third MMR vaccination to
boost protection. However, existing
immunity neutralizes a third MMR
vaccination limiting its effectiveness.
Genotype G MuV is the main cause of
recent outbreaks in the US and Europe,
and a genotype-matched vaccine has
been suggested as a solution for the
recurring outbreaks.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
used structure-guided design to create
immunogen constructs aimed at
stabilizing the measles and mumps F
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
glycoproteins in their prefusion
conformations. This was achieved by
following the discovery that the prefusion stabilized F glycoproteins from
other members of the paramyxoviridae
family induced high titer neutralizing
responses.
The researchers developed
recombinant immunogens based on: (a)
The measles F glycoprotein trimer
stabilized in its prefusion conformation
(preF–MeV); (b) genotype G mumps F
glycoprotein trimers stabilized in its
prefusion conformation (preF–MuV); (c)
a chimera in which a genotype G
mumps F glycoprotein trimer stabilized
in its prefusion conformation is fused
with mumps HN protein (preF–HN);
and (d) a chimera in which a genotype
G mumps F glycoprotein trimer
stabilized in its prefusion conformation
is fused with measles H protein (preF–
MuV/MeV H).
The prefusion stabilization of both the
mumps and measles F glycoproteins
relies on amino acid substitutions to
allow the formation of intra-protomer
disulfide bonds. Researchers found that
the preF and preF–HN immunogens are
stable for over a month at 37 °C and
hypothesize that lyophilized product
would be stable at room temperature for
months.
When mice are immunized in a
prime-boost-boost regimen with the
MuV immunogen constructs, the group
receiving the preF–HN immunogens
elicited similar antibody titers against
genotype G MuV and Jeryl Lynn strain
of MuV (genotype A) indicating that the
preF–HN immunogens offer broad
protection against divergent strains of
MuV. Interestingly, mice immunized in
a prime-boost regimen with the pre–F
MuV/MeV H chimeric immunogen
elicited antibody titers to both MuV and
MeV that are above the determined
protective thresholds.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• The products can be used as
measles or mumps vaccines.
Competitive Advantages:
• Currently, there is no licensed
recombinant measles or mumps vaccine
for use as boosters as a third
vaccination.
• The preF–HN immunogens offer
broad protection against divergent
strains of mumps.
• The stabilized prefusion F
molecules may be deliverable as mRNA
vaccines, increasing yields of expressed
antigen and presentation of the optimal
conformation of target proteins.
E:\FR\FM\23APN1.SGM
23APN1
Federal Register / Vol. 85, No. 79 / Thursday, April 23, 2020 / Notices
• PreF and preF–HN immunogens are
stable for over a month at 37 °C, the
lyophilized product may be stable at
room temperature for months.
• Recombinant vaccine production is
scalable, cost-effective vaccine
production can be achieved.
Development Stage: Preclinical
Research.
Inventors: Barney Graham, Ph.D.
(NIAID); Guillaume Stewart-Jones, Ph.D.
(NIAID).
Intellectual Property: HHS Reference
Number E–153–2019 includes U.S.
Provisional Patent Application Number
62/946,902 filed 12/11/2019.
Licensing Contact: To license this
technology, please contact Amy F.
Petrik, Ph.D., 240–627–3721;
amy.petrik@nih.gov.
Dated: April 12, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–08561 Filed 4–22–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Thio Compounds and
Thalidomide Analogues for the
Treatment of Neurological Diseases
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute on
Aging and the National Cancer Institute,
institutes of the National Institutes of
Health, Department of Health and
Human Services, are contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. and foreign Patents and Patent
Applications listed in the
Supplementary Information section of
this notice to AevisBio, Inc. located in
814 W Diamond Ave., Suite 203,
Gaithersburg, MD 20870.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute on
Aging c/o National Cancer Institute’s
Technology Transfer Center on or before
May 8, 2020 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Merissa Baxter, Ph.D.,
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:28 Apr 22, 2020
Jkt 250001
Medical Center Drive, Rm. 1E406 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702, Telephone: 240–276–7234, Email:
merissa.baxter@nih.gov.
SUPPLEMENTARY INFORMATION:
Intellectually Property
United States Patent No. 8,927,725,
issued January 6, 2015 and entitled
‘‘Thio Compounds’’ [HHS Reference No.
E–045–2012–0–US–01]; United States
Patent No. 9,084,783, issued July 21,
2015 and entitled ‘‘Thio
Compounds’’[HHS Reference No. E–
045–2012–0–US–02]; United States
Patent No. 9,623,020, issued April 18,
2017 and entitled ‘‘Thio Compounds’’
[HHS Reference No. E–045–2012–0–
US–03]; United States Patent No.
10,220,028, issued March 5, 2019 and
entitled ‘‘Thio Compounds’’ [HHS
Reference No. E–045–2012–0–US–04];
US Provisional Patent Application No.
62/235,105, filed on September 30, 2015
and entitled ‘‘Thalidomide Analogs and
Methods of Use’’ [HHS Reference No. E–
208–2015–0–US–01]; PCT Patent
Application No. PCT/US2016/054430,
filed on September 29, 2016 and
entitled, ‘‘Thalidomide Analogs and
Methods of Use’’ [HHS Reference No. E–
208–2015–0–PCT–02]; Australian Patent
Application No. 2016330967, filed on
September 29, 2016 and entitled
‘‘Thalidomide Analogs and Methods of
Use’’ [HHS Reference No. E–208–2015–
0–AU–03]; Canadian Patent Application
No. 3000661, filed on September 29,
2019 and entitled ‘‘Thalidomide
Analogs and Methods of Use’’ [HHS
Reference No. E–208–2015–0–CA–04];
European Patent Application No.
16782148.7, filed on September 29,
2019 and entitled ‘‘Thalidomide
Analogs and Methods of Use’’ [HHS
Reference No. E–208–2015–0–EP–05];
South Korean Patent Application No.
10–2018–7012347, filed on April 13,
2018 and entitled ‘‘Thalidomide
Analogs and Methods of Use’’ [HHS
Reference No. E–208–2015–0–KR–06];
and United States Patent Application
No. 15/764,193, filed on March 28, 2018
and entitled ‘‘Thalidomide Analogs and
Methods of Use’’ [HHS Reference No. E–
208–2015–US–07].
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be world-wide, and the
field of use may be limited to the use
of Licensed Patent Rights for the
following: ‘‘The development,
production, and commercialization of a
select subset of thalidomide/
lenalidomide/pomalidomide (POMA)
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22743
analogue compounds for the therapeutic
treatment of neurological disorders
prevalent in aging: Specifically,
Traumatic Brain Injury (TBI),
Alzheimer’s disease (AD), Parkinson’s
disease (PD), and Multiple Sclerosis
(MS).’’
These technologies disclose novel
thalidomide, lenalidomide, and
pomalidomide analogues that can
potentially be used for the treatment of
neurological diseases, autoimmunity,
and/or cancer.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Institute on Aging receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: April 13, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–08560 Filed 4–22–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2020–0002; Internal
Agency Docket No. FEMA–B–2014]
Proposed Flood Hazard
Determinations
Federal Emergency
Management Agency; DHS.
ACTION: Notice; correction.
AGENCY:
On March 13, 2020, FEMA
published in the Federal Register a
proposed flood hazard determination
notice that contained an erroneous
SUMMARY:
E:\FR\FM\23APN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Notices]
[Pages 22742-22743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08561]
-----------------------------------------------------------------------
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 invention listed below is owned by an agency of the U.S.
Government and is available for licensing 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: Amy F. Petrik, Ph.D., 240-627-3721;
[email protected]. Licensing information and copies of the U.S. patent
application listed below may be obtained by communicating with the
indicated licensing contact at the Technology Transfer and Intellectual
Property Office, National Institute of Allergy and Infectious Diseases,
5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed
Confidential Disclosure Agreement will be required to receive copies of
unpublished patent applications.
SUPPLEMENTARY INFORMATION: Technology description follows:
Recombinant Prefusion Measles and Mumps F and F-HN (H) Glycoproteins
for Vaccine Development.
Description of Technology: The Measles virus (MeV) and Mumps virus
(MuV) are highly contagious paramyxoviruses that can be transmitted by
respiratory droplets from or on direct contact with an infected person.
The resulting diseases can lead to serious complications or death among
children. The existing vaccines for MeV and MuV are live attenuated
virus vaccines which are administered in two subcutaneous doses at 1
year of age and as early as one month later. Two doses of a combination
measles, mumps and rubella vaccine are 97% effective against measles
and 88% against mumps. A single dose of a combination measles, mumps,
and rubella vaccine is 93% effective against measles and 78% effective
against mumps.
Despite the effectiveness of the current licensed vaccines against
MeV and MuV, incidences of both have increased in recent years.
Contributing factors include reduced vaccination rates (especially in
the U.S) due to vaccine hesitancy and circulation of divergent strains
against which the licensed MMR vaccine offers limited protection.
In the case of MuV, recent studies have shown that immunity wanes
significantly after the second MMR vaccination which normally occurs in
childhood. In response to recent recurring MuV disease outbreaks in the
U.S and Europe, the Advisory Committee on Immunization Practices is
advising a third MMR vaccination to boost protection. However, existing
immunity neutralizes a third MMR vaccination limiting its
effectiveness. Genotype G MuV is the main cause of recent outbreaks in
the US and Europe, and a genotype-matched vaccine has been suggested as
a solution for the recurring outbreaks.
Researchers at the Vaccine Research Center (VRC) of the National
Institute of Allergy and Infectious Diseases (NIAID) used structure-
guided design to create immunogen constructs aimed at stabilizing the
measles and mumps F glycoproteins in their prefusion conformations.
This was achieved by following the discovery that the pre-fusion
stabilized F glycoproteins from other members of the paramyxoviridae
family induced high titer neutralizing responses.
The researchers developed recombinant immunogens based on: (a) The
measles F glycoprotein trimer stabilized in its prefusion conformation
(preF-MeV); (b) genotype G mumps F glycoprotein trimers stabilized in
its prefusion conformation (preF-MuV); (c) a chimera in which a
genotype G mumps F glycoprotein trimer stabilized in its prefusion
conformation is fused with mumps HN protein (preF-HN); and (d) a
chimera in which a genotype G mumps F glycoprotein trimer stabilized in
its prefusion conformation is fused with measles H protein (preF-MuV/
MeV H).
The prefusion stabilization of both the mumps and measles F
glycoproteins relies on amino acid substitutions to allow the formation
of intra-protomer disulfide bonds. Researchers found that the preF and
preF-HN immunogens are stable for over a month at 37 [deg]C and
hypothesize that lyophilized product would be stable at room
temperature for months.
When mice are immunized in a prime-boost-boost regimen with the MuV
immunogen constructs, the group receiving the preF-HN immunogens
elicited similar antibody titers against genotype G MuV and Jeryl Lynn
strain of MuV (genotype A) indicating that the preF-HN immunogens offer
broad protection against divergent strains of MuV. Interestingly, mice
immunized in a prime-boost regimen with the pre-F MuV/MeV H chimeric
immunogen elicited antibody titers to both MuV and MeV that are above
the determined protective thresholds.
This technology is available for licensing for commercial
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
Potential Commercial Applications:
The products can be used as measles or mumps vaccines.
Competitive Advantages:
Currently, there is no licensed recombinant measles or
mumps vaccine for use as boosters as a third vaccination.
The preF-HN immunogens offer broad protection against
divergent strains of mumps.
The stabilized prefusion F molecules may be deliverable as
mRNA vaccines, increasing yields of expressed antigen and presentation
of the optimal conformation of target proteins.
[[Page 22743]]
PreF and preF-HN immunogens are stable for over a month at
37 [deg]C, the lyophilized product may be stable at room temperature
for months.
Recombinant vaccine production is scalable, cost-effective
vaccine production can be achieved.
Development Stage: Preclinical Research.
Inventors: Barney Graham, Ph.D. (NIAID); Guillaume Stewart-Jones,
Ph.D. (NIAID).
Intellectual Property: HHS Reference Number E-153-2019 includes
U.S. Provisional Patent Application Number 62/946,902 filed 12/11/2019.
Licensing Contact: To license this technology, please contact Amy
F. Petrik, Ph.D., 240-627-3721; [email protected].
Dated: April 12, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-08561 Filed 4-22-20; 8:45 am]
BILLING CODE 4140-01-P
