Prospective Grant of Exclusive Patent Commercialization License: N6, a Novel, Broad, Highly Potent HIV-Specific Antibody and a Broadly Neutralizing Human Anti-HIV Monoclonal Antibody (10E8) Capable of Neutralizing Most HIV-1 Strains, 41607-41608 [2020-14836]
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Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
Dated: July 7, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–14948 Filed 7–9–20; 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
jbell on DSKJLSW7X2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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;
Neuropsychiatric Disorders and Review of
PAR–19–289 Applications.
Date: August 4, 2020.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Molecular & Cellular Neurobiology.
Date: August 4, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Peter B. Guthrie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142,
MSC 7850, Bethesda, MD 20892, (301) 435–
1239, guthriep@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Glia.
Date: August 5, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Sep<11>2014
18:28 Jul 09, 2020
Jkt 250001
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Peter B. Guthrie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142,
MSC 7850, Bethesda, MD 20892, (301) 435–
1239, guthriep@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 7, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–14950 Filed 7–9–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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; Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19) (R21,
R01 Clinical Trials Not Allowed).
Date: July 30, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: James T. Snyder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities/
Room 3G31B, National Institute of Allergy
and Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Bethesda, MD 20892–9834, (240) 669–5060,
james.snyder@nih.gov.
Frm 00093
Fmt 4703
Sfmt 4703
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 2, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–14808 Filed 7–9–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
Commercialization License: N6, a
Novel, Broad, Highly Potent HIVSpecific Antibody and a Broadly
Neutralizing Human Anti-HIV
Monoclonal Antibody (10E8) Capable
of Neutralizing Most HIV–1 Strains
National Institutes of Health.
Notice.
AGENCY:
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
PO 00000
41607
ACTION:
The National Institute of
Allergy and Infectious Diseases (NIAID),
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent
commercialization license to
RNAceuticals, Inc. located at 12 Indian
Trail Road, Woodbridge, CT, USA to
practice the inventions embodied in the
patent applications listed in the
Supplementary Information section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the Technology Transfer
and Intellectual Property Office,
National Institute of Allergy and
Infectious Diseases, on or before July 27,
2020 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent commercialization
license should be directed to: Chris
Kornak, Lead Technology Transfer and
Patent Specialist, Technology Transfer
and Intellectual Property Office,
National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane,
Suite 6D, MSC 9804, Rockville, MD
20852–9804, phone number 240–627–
3705; Email: chris.kornak@nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement.
N6: To date, NIAID has filed the
following patent applications for this
matter: Two U.S. Provisionals (E–131–
SUMMARY:
E:\FR\FM\10JYN1.SGM
10JYN1
jbell on DSKJLSW7X2PROD with NOTICES
41608
Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
2015–0–US–01, 62/136,228, filed on 03/
20/2015 and E–131–2015–1–US–01, 62/
250,378 filed on 11/03/2015) that were
combined into one PCT Application (E–
131–2015–2–PCT–01, PCT/US2016/
023145, filed on 03/18/2016), and
entered the national stage in the United
States (E–131–2015–2–US–07, 15/
559,791, filed on 09/19/2017 and E–
131–2015–2–US–09, 16/786,267, filed
on 02/10/2020), Europe (E–131–2015–
2–EP–05, 16716979.6 and E–131–2015–
2–EP–10, 20156388.9), Canada (E–131–
2015–2–CA–03, 2,980,005), Australia
(E–131–2015–2–AU–02, 2016235541),
China (E–131–2015–2–CN–04,
201680028822.8), South Africa (E–131–
2015–2–ZA–08, 2017/06155), and India
(E–131–2015–2–IN–06, 201737032671).
10E8: NIAID has filed the following
patent applications for this matter, three
U.S. Provisionals (E–253–2011–0–US–
01, 61/556,660, filed on 11/07/2011, E–
253–2011–1–US–01, 61/672,708, filed
on 07/17/2012, and E–253–2011–2–US–
01, 61/698,480, filed on 09/07/2012)
that were combined into one PCT
application (E–253–2011–3–PCT–01,
PCT/US2012/063958, filed on 11/07/
2012), and entered the national stage, in
seven countries: United States (E–253–
2011–3–US–05, 14/356,557, filed on 05/
06/2014, E–253–2011–4–US–01, 14/
450,773, filed on 08/04/2014, E–253–
2011–3–US–09, 15/226,744, filed on 08/
02/2016, E–253–2011–3–US–13, 15/
699,902, filed on 09/08/2017), Europe
(E–253–2011–3–EP–03, 12847241.2),
China (E–253–2011–3–CN–02,
201280065580.1), India (E–253–2011–3–
IN–04, 3678/DELNP/2014), South Africa
(E–253–2011–3–ZA–06, 2014/03264),
Brazil (E–253–2011–3–BR–07,
BR112014010823–4), and Russia (E–
253–2011–3–RU–08, 2014118462).
All rights in these inventions have
been assigned to the Government of the
United States of America.
The prospective exclusive patent
commercialization license territory may
be worldwide and the field of use may
be limited to: (1) Administration to
humans of DNA and/or RNA including
without limitation modified RNA
encoding a protein or proteins,
containing all or some of the CDRs of N6
and (2) Administration to humans of
DNA and/or RNA including without
limitation modified RNA encoding a
protein or proteins, containing all or
some of the CDRs of 10E8.
The N6 antibody has evolved a
unique mode of binding that depends
less on a variable area of the HIV
envelope known as the V5 region and
focuses more on conserved regions,
which change relatively little among
HIV strains. This allows N6 to tolerate
changes in the HIV envelope, including
VerDate Sep<11>2014
18:28 Jul 09, 2020
Jkt 250001
the attachment of sugars in the V5
region, a major mechanism by which
HIV develops resistance to other VRC01class antibodies. N6 was shown in preclinical studies to neutralize
approximately 98 percent of HIV
isolates tested. The studies also
demonstrate that N6 neutralizes
approximately 80 percent of HIV
isolates which were resistant to other
antibodies of the same class, and does
so very potently. Its breadth and
potency makes N6 a highly desirable
candidate for development in
therapeutic or prophylactic strategies.
An abstract for this invention was
published in the Federal Register on
March 13, 2017.
The other invention, 10E8, has great
potential to provide passive protection
from infection, as a therapeutic, or as a
tool for the development of vaccine
immunogens. 10E8 is one of the most
potent HIV-neutralizing antibodies
isolated thus far and it can potently
neutralize up to 98% of genetically
diverse HIV–1 strains. 10E8 is specific
to the membrane-proximal external
region (MPER) of the HIV envelope
protein, GP41. An abstract for this
invention was published in the Federal
Register on April 24th, 2012 and June
24th, 2014.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive patent
commercialization license will be
royalty bearing and may be granted
unless within fifteen (15) days from the
date of this published notice, the
National Institute of Allergy and
Infectious Diseases 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
commercialization license. 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 from these license
applications will be made only as
required and upon a request under the
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
Freedom of Information Act, 5 U.S.C.
552.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2020–14836 Filed 7–9–20; 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–2040]
Changes in Flood Hazard
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This notice lists communities
where the addition or modification of
Base Flood Elevations (BFEs), base flood
depths, Special Flood Hazard Area
(SFHA) boundaries or zone
designations, or the regulatory floodway
(hereinafter referred to as flood hazard
determinations), as shown on the Flood
Insurance Rate Maps (FIRMs), and
where applicable, in the supporting
Flood Insurance Study (FIS) reports,
prepared by the Federal Emergency
Management Agency (FEMA) for each
community, is appropriate because of
new scientific or technical data. The
FIRM, and where applicable, portions of
the FIS report, have been revised to
reflect these flood hazard
determinations through issuance of a
Letter of Map Revision (LOMR), in
accordance with Federal Regulations.
The LOMR will be used by insurance
agents and others to calculate
appropriate flood insurance premium
rates for new buildings and the contents
of those buildings. For rating purposes,
the currently effective community
number is shown in the table below and
must be used for all new policies and
renewals.
DATES: These flood hazard
determinations will be finalized on the
dates listed in the table below and
revise the FIRM panels and FIS report
in effect prior to this determination for
the listed communities.
From the date of the second
publication of notification of these
changes in a newspaper of local
circulation, any person has 90 days in
which to request through the
community that the Deputy Associate
Administrator for Insurance and
SUMMARY:
E:\FR\FM\10JYN1.SGM
10JYN1
]]>Agencies
[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41607-41608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14836]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent Commercialization License:
N6, a Novel, Broad, Highly Potent HIV-Specific Antibody and a Broadly
Neutralizing Human Anti-HIV Monoclonal Antibody (10E8) Capable of
Neutralizing Most HIV-1 Strains
AGENCY: National Institutes of Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases
(NIAID), an institute of the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive patent commercialization license to RNAceuticals, Inc.
located at 12 Indian Trail Road, Woodbridge, CT, USA to practice the
inventions embodied in the patent applications listed in the
Supplementary Information section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, on or
before July 27, 2020 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated exclusive patent
commercialization license should be directed to: Chris Kornak, Lead
Technology Transfer and Patent Specialist, Technology Transfer and
Intellectual Property Office, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane, Suite 6D, MSC 9804, Rockville,
MD 20852-9804, phone number 240-627-3705; Email: [email protected].
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement.
N6: To date, NIAID has filed the following patent applications for
this matter: Two U.S. Provisionals (E-131-
[[Page 41608]]
2015-0-US-01, 62/136,228, filed on 03/20/2015 and E-131-2015-1-US-01,
62/250,378 filed on 11/03/2015) that were combined into one PCT
Application (E-131-2015-2-PCT-01, PCT/US2016/023145, filed on 03/18/
2016), and entered the national stage in the United States (E-131-2015-
2-US-07, 15/559,791, filed on 09/19/2017 and E-131-2015-2-US-09, 16/
786,267, filed on 02/10/2020), Europe (E-131-2015-2-EP-05, 16716979.6
and E-131-2015-2-EP-10, 20156388.9), Canada (E-131-2015-2-CA-03,
2,980,005), Australia (E-131-2015-2-AU-02, 2016235541), China (E-131-
2015-2-CN-04, 201680028822.8), South Africa (E-131-2015-2-ZA-08, 2017/
06155), and India (E-131-2015-2-IN-06, 201737032671).
10E8: NIAID has filed the following patent applications for this
matter, three U.S. Provisionals (E-253-2011-0-US-01, 61/556,660, filed
on 11/07/2011, E-253-2011-1-US-01, 61/672,708, filed on 07/17/2012, and
E-253-2011-2-US-01, 61/698,480, filed on 09/07/2012) that were combined
into one PCT application (E-253-2011-3-PCT-01, PCT/US2012/063958, filed
on 11/07/2012), and entered the national stage, in seven countries:
United States (E-253-2011-3-US-05, 14/356,557, filed on 05/06/2014, E-
253-2011-4-US-01, 14/450,773, filed on 08/04/2014, E-253-2011-3-US-09,
15/226,744, filed on 08/02/2016, E-253-2011-3-US-13, 15/699,902, filed
on 09/08/2017), Europe (E-253-2011-3-EP-03, 12847241.2), China (E-253-
2011-3-CN-02, 201280065580.1), India (E-253-2011-3-IN-04, 3678/DELNP/
2014), South Africa (E-253-2011-3-ZA-06, 2014/03264), Brazil (E-253-
2011-3-BR-07, BR112014010823-4), and Russia (E-253-2011-3-RU-08,
2014118462).
All rights in these inventions have been assigned to the Government
of the United States of America.
The prospective exclusive patent commercialization license
territory may be worldwide and the field of use may be limited to: (1)
Administration to humans of DNA and/or RNA including without limitation
modified RNA encoding a protein or proteins, containing all or some of
the CDRs of N6 and (2) Administration to humans of DNA and/or RNA
including without limitation modified RNA encoding a protein or
proteins, containing all or some of the CDRs of 10E8.
The N6 antibody has evolved a unique mode of binding that depends
less on a variable area of the HIV envelope known as the V5 region and
focuses more on conserved regions, which change relatively little among
HIV strains. This allows N6 to tolerate changes in the HIV envelope,
including the attachment of sugars in the V5 region, a major mechanism
by which HIV develops resistance to other VRC01-class antibodies. N6
was shown in pre-clinical studies to neutralize approximately 98
percent of HIV isolates tested. The studies also demonstrate that N6
neutralizes approximately 80 percent of HIV isolates which were
resistant to other antibodies of the same class, and does so very
potently. Its breadth and potency makes N6 a highly desirable candidate
for development in therapeutic or prophylactic strategies. An abstract
for this invention was published in the Federal Register on March 13,
2017.
The other invention, 10E8, has great potential to provide passive
protection from infection, as a therapeutic, or as a tool for the
development of vaccine immunogens. 10E8 is one of the most potent HIV-
neutralizing antibodies isolated thus far and it can potently
neutralize up to 98% of genetically diverse HIV-1 strains. 10E8 is
specific to the membrane-proximal external region (MPER) of the HIV
envelope protein, GP41. An abstract for this invention was published in
the Federal Register on April 24th, 2012 and June 24th, 2014.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive patent commercialization license
will be royalty bearing and may be granted unless within fifteen (15)
days from the date of this published notice, the National Institute of
Allergy and Infectious Diseases 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.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent
commercialization license. 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 from these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-14836 Filed 7-9-20; 8:45 am]
BILLING CODE 4140-01-P
