Government-Owned Inventions; Availability for Licensing, 61961 [2020-21708]
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Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
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
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to receive copies of unpublished patent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.
SUMMARY:
Structure-Based Design of SARS2-CoV–
2 Spike Immunogens Stabilized in the
RBD-All Down Conformation
jbell on DSKJLSW7X2PROD with NOTICES
Description of Technology:
SARS-CoV–2 has emerged as a global
pathogen, sparking urgent vaccine
development efforts. The trimeric
SARS-CoV–2 spike appears to be a
leading vaccine antigen. However, the
inability of antibodies such as CR3022,
which binds tightly to a cryptic spike
epitope, to neutralize SARS-CoV–2
suggests a spike-based means of
neutralization escape.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
sought to understand how antibodies
with high affinity fail to neutralize the
SARS-CoV–2. To that end, the
researchers characterized the SARSCoV–2 spike protein conformational
changes as a function of pH and
observed that at endosomal pH the spike
protein has a conformation in which all
of the receptor binding domains (RBD)
are in a down conformation which
VerDate Sep<11>2014
22:13 Sep 30, 2020
Jkt 253001
could explain the virus’ ability to escape
neutralization in the endosome.
Hypothesizing that SARS-CoV–2
escapes neutralization through pHdependent conformational masking, the
researchers designed spike proteins
with mutations to stabilize the spike in
the RBD-all down conformation. Such
designs include cavity-filling mutations,
disulfides, aspartic acid to asparagine
mutations, proline mutations, and other
sequence modifications to fix the spike
protein in its RBD-all down
conformation so that immunization at a
physiological pH will elicit antibodies
that can recognize the low pH-stabilized
all RBD-down conformation of the spike
protein and no longer be susceptible to
pH-induced neutralization escape.
Immunogenicity studies are underway
to determine which of the designs will
yield a neutralizing immune response in
mice. Pending results in mice, a lead
candidate will be selected for studies in
nonhuman primates.
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
• An improved stabilized spike
immunogen for the development of
protective SARS-CoV–2 vaccine.
Competitive Advantages
• Stabilized SARS-CoV–2 spike
variants with potential to elicit higher
levels of neutralizing antibodies than
current related vaccine development.
• Identification of a methodology to
screen for improved spike variants (by
assessing binding by neutralizing versus
non-neutralizing antibodies).
Development Stage: Preclinical
Research.
Inventors: Peter Dak-Pin Kwong
(NIAID); Tongqing Zhou (NIAID);
Yaroslav Tsybovsky (NCI); Adam
Shabbir Olia (NIAID); John R. Mascola
(NIAID).
Publications: Zhou, T et al., (2020).
Cryo-EM Structures Delineate a pHDependent Switch that Mediates
Endosomal Positioning of SARS-CoV–2
Spike Receptor-Binding Domains.
BioRxiv.
Intellectual Property: HHS Reference
Number E–187–2020 includes U.S.
Provisional Patent Application Number
63/046,603, filed 06/30/2020.
Licensing Contact: To license this
technology, please contact Amy F.
Petrik, Ph.D., 240–627–3721;
amy.petrik@nih.gov.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
61961
Dated: September 17, 2020.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2020–21708 Filed 9–30–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs using Urine or Oral Fluid
(Mandatory Guidelines).
FOR FURTHER INFORMATION CONTACT:
Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Donovan@
samhsa.hhs.gov (email).
SUPPLEMENTARY INFORMATION: A notice
listing all currently HHS-certified
laboratories and IITFs is published in
the Federal Register during the first
week of each month. If any laboratory or
IITF certification is suspended or
revoked, the laboratory or IITF will be
omitted from subsequent lists until such
time as it is restored to full certification
under the Mandatory Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
internet at https://www.samhsa.gov/
workplace/resources/drug-testing/
certified-lab-list.
The Department of Health and Human
Services (HHS) notifies federal agencies
of the laboratories and Instrumented
Initial Testing Facilities (IITFs)
currently certified to meet the standards
of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs
SUMMARY:
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Page 61961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21708]
[[Page 61961]]
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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.
-----------------------------------------------------------------------
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.
Structure-Based Design of SARS2-CoV-2 Spike Immunogens Stabilized in
the RBD-All Down Conformation
Description of Technology:
SARS-CoV-2 has emerged as a global pathogen, sparking urgent
vaccine development efforts. The trimeric SARS-CoV-2 spike appears to
be a leading vaccine antigen. However, the inability of antibodies such
as CR3022, which binds tightly to a cryptic spike epitope, to
neutralize SARS-CoV-2 suggests a spike-based means of neutralization
escape.
Researchers at the Vaccine Research Center (VRC) of the National
Institute of Allergy and Infectious Diseases (NIAID) sought to
understand how antibodies with high affinity fail to neutralize the
SARS-CoV-2. To that end, the researchers characterized the SARS-CoV-2
spike protein conformational changes as a function of pH and observed
that at endosomal pH the spike protein has a conformation in which all
of the receptor binding domains (RBD) are in a down conformation which
could explain the virus' ability to escape neutralization in the
endosome.
Hypothesizing that SARS-CoV-2 escapes neutralization through pH-
dependent conformational masking, the researchers designed spike
proteins with mutations to stabilize the spike in the RBD-all down
conformation. Such designs include cavity-filling mutations,
disulfides, aspartic acid to asparagine mutations, proline mutations,
and other sequence modifications to fix the spike protein in its RBD-
all down conformation so that immunization at a physiological pH will
elicit antibodies that can recognize the low pH-stabilized all RBD-down
conformation of the spike protein and no longer be susceptible to pH-
induced neutralization escape.
Immunogenicity studies are underway to determine which of the
designs will yield a neutralizing immune response in mice. Pending
results in mice, a lead candidate will be selected for studies in
nonhuman primates.
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
An improved stabilized spike immunogen for the development
of protective SARS-CoV-2 vaccine.
Competitive Advantages
Stabilized SARS-CoV-2 spike variants with potential to
elicit higher levels of neutralizing antibodies than current related
vaccine development.
Identification of a methodology to screen for improved
spike variants (by assessing binding by neutralizing versus non-
neutralizing antibodies).
Development Stage: Preclinical Research.
Inventors: Peter Dak-Pin Kwong (NIAID); Tongqing Zhou (NIAID);
Yaroslav Tsybovsky (NCI); Adam Shabbir Olia (NIAID); John R. Mascola
(NIAID).
Publications: Zhou, T et al., (2020). Cryo-EM Structures Delineate
a pH-Dependent Switch that Mediates Endosomal Positioning of SARS-CoV-2
Spike Receptor-Binding Domains. BioRxiv.
Intellectual Property: HHS Reference Number E-187-2020 includes
U.S. Provisional Patent Application Number 63/046,603, filed 06/30/
2020.
Licensing Contact: To license this technology, please contact Amy
F. Petrik, Ph.D., 240-627-3721; [email protected].
Dated: September 17, 2020.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-21708 Filed 9-30-20; 8:45 am]
BILLING CODE 4140-01-P
