Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting, 19896 [2021-07735]
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19896
Federal Register / Vol. 86, No. 71 / Thursday, April 15, 2021 / Notices
Human Monoclonal and Bispecific
Antibodies Targeting SARS–CoV–2
Coronavirus
Description of Technology
SARS–CoV–2 is a virus of the
Coronavirus family that has emerged as
a major public health concern. The first
cases of SARS–CoV–2 were reported in
China and rapidly spread worldwide
leading to a global pandemic. The
highest morbidity and mortality have
been reported in the elderly and
immunocompromised. Antibody
therapeutics have great importance for
advanced cases of SARS–CoV–2 where
a vaccine would not be effective and
may be more effective than a vaccine in
certain high-risk populations.
Scientists at NIAID have developed
recombinant monoclonal antibodies that
are effective in vitro and in vivo at
neutralizing SARS–CoV–2. Based on
whether they are mono-specific or bispecific and where they bind to the
SARS–CoV–2 virus, these antibodies
can be subdivided into four groups that
target (A) the receptor-binding-domain
(RBD) of the SARS–COV–2 spike
protein, (B) the N-terminal domain
(NTD) of the SARS–COV–2 spike
protein, (C) dual locations on the RBD,
or (D) both the RBD and NTD. Crucially,
these antibodies effectively neutralize
the emerging B.1.1.7 and B.1.351 SARS–
CoV–2 variants of concern.
These recombinant monoclonal
antibodies can be used alone, in
combination, or with other therapeutics
for the treatment of SARS–COV–2. In
addition to their potential as
therapeutics, these antibodies against
SARS–CoV–2 can be used as
prophylactics and in assay
development. They can contribute to the
surveillance, diagnosis, and prevention
of SARS–COV–2. Furthermore, the
specific antibody sequences and targets
will inform vaccine development and
establishment of long-term immunity.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
jbell on DSKJLSW7X2PROD with NOTICES
Potential Commercial Applications
• Prophylaxis or therapeutics against
SARS–CoV–2.
• Diagnostics and surveillance of
SARS–CoV–2.
• Vaccine research.
Competitive Advantages
• Potent neutralizing activity against
SARS–CoV–2, including against B.1.1.7
and B.1.351 variants.
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17:35 Apr 14, 2021
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• Prophylactic usage against SARS–
CoV–2 in normal or high-risk
populations.
• Therapeutic treatment, alone or in
combination, in patients with SARS–
CoV–2 infection.
• Assay development for
surveillance, diagnostic, and prevention
measures.
• Identification of vaccine candidates
which elicit protective antibodies
against SARS–CoV–2 infections.
Development Stage
• Pre-clinical.
Inventors: Joshua Tan, Ph.D., Peter
Crompton, M.D., Hyeseon Cho, Ph.D.,
Mary Peterson, Kristina Kay GonzalesWartz, Ph.D., all of NIAID.
Publications: Cho, Hyeseon, et al.
‘‘Ultrapotent bispecific antibodies
neutralize emerging SARS–CoV–2
variants.’’ bioRxiv 2021.04.01.437942;
Intellectual Property: HHS Reference
No. E–030–2021–0; US provisional
application No. 63/127,077 filed on
December 17, 2020.
Licensing Contact: To license this
technology, please contact Dawn TaylorMulneix 301–767–5189 or dawn.taylormulneix@nih.gov, and reference E–030–
2021–0.
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 Dawn Taylor-Mulneix at 301–
767–5189 or dawn.taylor-mulneix@
nih.gov.
Dated: April 7, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–07709 Filed 4–14–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
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
PO 00000
Frm 00028
Fmt 4703
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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
Child Health and Human Development Initial
Review Group; Biobehavioral and Behavioral
Sciences Subcommittee.
Date: June 28, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: NICHD Offices, 6710B Rockledge
Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Clay Mash, Ph.D.,
Scientific Review Branch, Eunice Kennedy
Shriver National Institute of Child Health
and Human Development, NIH, 6710B
Rockledge Drive, Rm. 2131A, Bethesda, MD
20892, (301) 496–6866, mashc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: April 12, 2021.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–07735 Filed 4–14–21; 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 Meeting
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: Bioengineering
Sciences & Technologies Integrated Review
Group; Instrumentation and Systems
Development Study Section.
Date: June 17–18, 2021.
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[Federal Register Volume 86, Number 71 (Thursday, April 15, 2021)]
[Notices]
[Page 19896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07735]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human
Development; Notice of Closed Meeting
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 Child Health and Human
Development Initial Review Group; Biobehavioral and Behavioral
Sciences Subcommittee.
Date: June 28, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: NICHD Offices, 6710B Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Clay Mash, Ph.D., Scientific Review Branch,
Eunice Kennedy Shriver National Institute of Child Health and Human
Development, NIH, 6710B Rockledge Drive, Rm. 2131A, Bethesda, MD
20892, (301) 496-6866, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.864,
Population Research; 93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation Research; 93.209,
Contraception and Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: April 12, 2021.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-07735 Filed 4-14-21; 8:45 am]
BILLING CODE 4140-01-P
