83 FR 38716 - Government-Owned Inventions; Availability for Licensing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 152 (August 7, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 152 (August 7, 2018)
| Page Range | 38716-38717 | |
| FR Document | 2018-16835 |
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)] [Notices] [Pages 38716-38717] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16835] ----------------------------------------------------------------------- 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: Vince Contreras, Ph.D., 240-669-2823; vince.contreras@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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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. Substitutions-Modified Prefusion RSV F Proteins and Their Use Description of Technology: The respiratory syncytial virus (RSV) fusion (F) glycoprotein is the primary target of neutralizing antibodies. The F glycoprotein exists in at least two conformations, a meta-stable prefusion state, and an extremely stable postfusion state. Both states share several epitopes targeted by neutralizing antibodies, but it has been demonstrated that the prefusion conformation of F contains at least one epitope not present in the postfusion conformation. Natural infection results in neutralizing antibodies that are primarily directed against the prefusion conformation of F, not its postfusion conformation. The instability of the prefusion form of F has [[Page 38717]] hindered both its characterization and its use as a vaccine antigen. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases have overcome technical obstacles to produce a homogeneous, soluble RSV F glycoprotein vaccine which is stabilized in the prefusion conformation and has improved stability and immunogenicity compared to the native protein. Additionally, several modifications were introduced to remove the requirement for furin during production, resulting in an increase in expression levels of the immunogen. Stability of the immunogen was increased 20-fold as compared to DS-CAV1 (a prefusion-stabilized RSV F glycoprotein vaccine candidate that is currently being assessed in clinical trials) upon incubation at 60 [deg]C. In mice, these immunogens elicited neutralization titers that were 2 to 5-fold higher than DS-CAV1. 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. Potential Commercial Applications:Vaccine: RSV vaccine for human use. Probe: B cell-sorting probe to isolate potent neutralizing monoclonal antibodies. Diagnostics: To assess the titer of prefusion-specific antibodies in sera. Competitive Advantages: Increased stability compared to the current leading RSV vaccine candidate (DS-Cav1). Elicits increased neutralization titers in mice. Development Stage: In vivo testing (mice). Inventors: Peter D. Kwong (NIAID), M. Gordon Joyce (NIAID), Baoshan Zhang (NIAID), Man Chen (NIAID), Barney S. Graham (NIAID), John R. Mascola (NIAID), Aliaksandr A. Druz (NIAID), Wing-Pui Kong (NIAID), Ivelin Georgiev (NIAID), Yaroslav Tsybovsky (Leidos Biomedical Research), Paul V. Thomas (NIAID), Marie L. Pancera (NIAID), Mallika Sastry (NIAID), Cinque Soto (NIAID), Guillaume B.E. Stewart-Jones (NIAID), Yongping Yang (NIAID), Li Ou (NIAID), Ulrich Baxa (NCI), Emily Rundlet (NIAID), Joseph Van Galen (NIAID). Publications: Joyce, M. Gordon, et al., Nature structural & molecular biology, 23.9 (2016): 811; PMID: 27478931. Intellectual Property: HHS Reference Number E-064-2016: U.S. Patent Application No. 62/314,946 filed 03/29/2016; PCT Application Number PCT/US2017/024714 filed 03/29/2017 (pending). Related Intellectual Property: HHS Reference Number E-081-2013. Licensing Contact: Vince Contreras, Ph.D., 240-669-2823; vince.contreras@nih.gov. Dated: July 20, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018-16835 Filed 8-6-18; 8:45 am] BILLING CODE 4140-01-P
![38716 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices
Wednesday, September 19, 2018 will be this notice at least 5 days prior to the Dated: August 1, 2018.
presented to the working group prior to meeting. Melanie J. Pantoja,
the workshop. Any written comments Security: Visitors will be asked to Program Analyst, Office of Federal Advisory
received after the 5:00 p.m. ET, show one form of identification (for Committee Policy.
Wednesday, September 19, 2018 example, a government-issued photo ID, [FR Doc. 2018–16788 Filed 8–6–18; 8:45 am]
deadline through Tuesday, September driver’s license, or passport) and to state BILLING CODE 4140–01–P
25, 2018 will be provided to the the purpose of their visit. Also, as a part
working group either before or after the of security procedures, attendees should
meeting, depending on the volume of be prepared to present a photo ID at the DEPARTMENT OF HEALTH AND
comments received and the time meeting registration desk during the HUMAN SERVICES
required to process them in accordance check-in process. Pre-registration is
with privacy regulations and other recommended. Seating will be limited National Institutes of Health
applicable Federal policies. All written to the room capacity and seats will be
public comments and oral public on a first come, first serve basis, with Government-Owned Inventions;
comment statements received by the expedited check-in for those who are Availability for Licensing
deadlines for both oral and written pre-registered. AGENCY: National Institutes of Health,
public comments will be provided to Meeting schedule subject to change. HHS.
the IACC for their consideration and Information about the IACC is available
ACTION: Notice.
will become part of the public record. on the website: http://www.iacc.hhs.gov.
Attachments of copyrighted Dated: August 1, 2018. SUMMARY: The invention listed below is
publications are not permitted, but web Melanie J. Pantoja, owned by an agency of the U.S.
links or citations for any copyrighted Program Analyst, Office of Federal Advisory Government and is available for
works cited may be provided. Committee Policy. licensing to achieve expeditious
In the 2009 IACC Strategic Plan, the [FR Doc. 2018–16793 Filed 8–6–18; 8:45 am]
commercialization of results of
IACC listed the ‘‘Spirit of Collaboration’’ federally-funded research and
BILLING CODE 4140–01–P
as one of its core values, stating that, development. Foreign patent
‘‘We will treat others with respect, listen applications are filed on selected
to diverse views with open minds, DEPARTMENT OF HEALTH AND inventions to extend market coverage
discuss submitted public comments, HUMAN SERVICES for companies and may also be available
and foster discussions where for licensing.
participants can comfortably offer National Institutes of Health FOR FURTHER INFORMATION CONTACT:
opposing opinions.’’ In keeping with Vince Contreras, Ph.D., 240–669–2823;
this core value, the IACC and the NIMH National Institute on Aging; Notice of vince.contreras@nih.gov. Licensing
Office of Autism Research Coordination Closed Meeting information and copies of the U.S.
(OARC) ask that members of the public Pursuant to section 10(d) of the patent application listed below may be
who provide public comments or Federal Advisory Committee Act, as obtained by communicating with the
participate in meetings of the IACC also amended, notice is hereby given of the indicated licensing contact at the
seek to treat others with respect and following meeting. Technology Transfer and Intellectual
consideration in their communications The meeting will be closed to the Property Office, National Institute of
and actions, even when discussing public in accordance with the Allergy and Infectious Diseases, 5601
issues of genuine concern or provisions set forth in sections Fishers Lane, Rockville, MD 20852; tel.
disagreement. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 301–496–2644. A signed Confidential
Remote Access: The meeting will be as amended. The grant applications and Disclosure Agreement will be required
open to the public through a conference the discussions could disclose to receive copies of unpublished patent
call phone number and webcast live on confidential trade secrets or commercial applications.
the internet. Members of the public who property such as patentable material, SUPPLEMENTARY INFORMATION:
participate using the conference call and personal information concerning Technology description follows.
phone number will be able to listen to individuals associated with the grant
the meeting but will not be heard. If you Substitutions-Modified Prefusion RSV F
applications, the disclosure of which Proteins and Their Use
experience any technical problems with would constitute a clearly unwarranted
the webcast or conference call, please invasion of personal privacy. Description of Technology: The
send an e- mail to IACCPublicInquiries@ respiratory syncytial virus (RSV) fusion
Name of Committee: National Institute on
mail.nih.gov. Individuals wishing to (F) glycoprotein is the primary target of
Aging Initial Review Group, Biological Aging
participate in person or by using these Review Committee NIA–B. neutralizing antibodies. The F
electronic services and who need Date: September 27–28, 2018. glycoprotein exists in at least two
special assistance, such as captioning of Time: 2:00 p.m. to 3:00 p.m. conformations, a meta-stable prefusion
the conference call or other reasonable Agenda: To review and evaluate grant state, and an extremely stable postfusion
accommodations, should submit a applications. state. Both states share several epitopes
request to the Contact Person listed on Place: Bethesda Marriott, 5151 Pooks Hill targeted by neutralizing antibodies, but
this notice at least 5 days prior to the Rd., Bethesda, MD 20814 (Telephone it has been demonstrated that the
meeting. Conference Call). prefusion conformation of F contains at
daltland on DSKBBV9HB2PROD with NOTICES
Contact Person: Bita Nakhai, Ph.D.,
Special Accommodations: Individuals Scientific Review Branch, National Institute
least one epitope not present in the
who participate in person or by using on Aging, Gateway Bldg., 2C212, 7201 postfusion conformation. Natural
these electronic services and who need Wisconsin Avenue, Bethesda, MD 20814, infection results in neutralizing
special assistance, such as captioning of 301–402–7701, nakhaib@nia.nih.gov. antibodies that are primarily directed
the conference call or other reasonable (Catalogue of Federal Domestic Assistance against the prefusion conformation of F,
accommodations, should submit a Program Nos. 93.866, Aging Research, not its postfusion conformation. The
request to the Contact Person listed on National Institutes of Health, HHS) instability of the prefusion form of F has
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![Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38717
hindered both its characterization and US2017/024714 filed 03/29/2017 available to the public on its progress
its use as a vaccine antigen. (pending). under this Act.’’ The eighth ICCVAM
Researchers at the Vaccine Research Related Intellectual Property: HHS biennial progress report describing
Center (VRC) of the National Institute of Reference Number E–081–2013. ICCVAM activities and
Allergy and Infectious Diseases have Licensing Contact: Vince Contreras, accomplishments from January 2016
overcome technical obstacles to produce Ph.D., 240–669–2823; vince.contreras@ through December 2017 is now
a homogeneous, soluble RSV F nih.gov. available.
glycoprotein vaccine which is stabilized Dated: July 20, 2018. Summary of Report Contents: Key
in the prefusion conformation and has Suzanne M. Frisbie, ICCVAM, ICCVAM agency, and
improved stability and immunogenicity NICEATM accomplishments
Deputy Director, Technology Transfer and
compared to the native protein. Intellectual Property Office, National Institute summarized in the report include:
Additionally, several modifications of Allergy and Infectious Diseases. • Development of a strategic roadmap
were introduced to remove the for incorporating new approaches into
[FR Doc. 2018–16835 Filed 8–6–18; 8:45 am]
requirement for furin during safety testing of chemicals and medical
BILLING CODE 4140–01–P
production, resulting in an increase in products in the United States.
expression levels of the immunogen. • Publication of two guidance
Stability of the immunogen was DEPARTMENT OF HEALTH AND documents by the U.S. Environmental
increased 20-fold as compared to DS– HUMAN SERVICES Protection Agency (EPA) in 2016. One
CAV1 (a prefusion-stabilized RSV F included a policy statement to waive all
glycoprotein vaccine candidate that is National Institutes of Health acute dermal lethality studies for
currently being assessed in clinical pesticide formulations. The other
trials) upon incubation at 60 °C. In mice, Interagency Coordinating Committee described a transparent, stepwise
these immunogens elicited on the Validation of Alternative process for evaluating and
neutralization titers that were 2 to 5-fold Methods Biennial Progress Report: implementing alternative methods for
higher than DS–CAV1. 2016–2017; Availability of Report six-pack studies, which test for acute
This technology is available for systemic toxicity by the oral, dermal,
AGENCY: National Institutes of Health, and inhalation routes; skin and eye
licensing for commercial development HHS.
in accordance with 35 U.S.C. 209 and 37 irritation; and skin sensitization.
ACTION: Notice. • Publication of notices permitting
CFR part 404, as well as for further
development and evaluation under a SUMMARY: The National Toxicology removal of back-titration hamsters for
research collaboration. Program (NTP) Interagency Center for potency testing of vaccines containing
Potential Commercial Applications: the Evaluation of Alternative Leptospira pomona and Leptospira
• Vaccine: RSV vaccine for human Toxicological Methods (NICEATM) grippotyphosa by the U.S. Department
use. announces availability of the of Agriculture, further reducing the
• Probe: B cell-sorting probe to isolate Interagency Coordinating Committee on number of hamsters required for
potent neutralizing monoclonal the Validation of Alternative Methods leptospirosis vaccine potency testing.
antibodies. • Publication by the U.S. Food and
(ICCVAM) Biennial Progress Report:
• Diagnostics: To assess the titer of 2016–2017. This report, prepared in
Drug Administration of the Predictive
prefusion-specific antibodies in sera. Toxicology Roadmap for integrating
accordance with requirements of the
Competitive Advantages: predictive toxicology methods into
ICCVAM Authorization Act of 2000,
• Increased stability compared to the safety and risk assessments.
describes activities and • Development by NICEATM and
current leading RSV vaccine candidate
accomplishments from January 2016 EPA scientists of a defined approach
(DS-Cav1).
through December 2017.
• Elicits increased neutralization that combines data from 11 high-
titers in mice. ADDRESSES: The report is available at throughput screening assays with a
Development Stage: http://ntp.niehs.nih.gov/iccvamreport/ computational model to identify
• In vivo testing (mice). 2017/index.html. chemicals with the potential to interact
Inventors: Peter D. Kwong (NIAID), M. FOR FURTHER INFORMATION CONTACT: Dr. with the androgen receptor pathway.
Gordon Joyce (NIAID), Baoshan Zhang Warren Casey, Director, NICEATM; • Development by NICEATM and
(NIAID), Man Chen (NIAID), Barney S. email: warren.casey@nih.gov; telephone: ICCVAM scientists of a defined
Graham (NIAID), John R. Mascola (984) 287–3118. approach that uses non-animal
(NIAID), Aliaksandr A. Druz (NIAID), SUPPLEMENTARY INFORMATION: approaches to predict murine local
Wing-Pui Kong (NIAID), Ivelin Georgiev Background: The ICCVAM lymph node assay outcomes and human
(NIAID), Yaroslav Tsybovsky (Leidos Authorization Act of 2000 established skin sensitization hazard and potency.
Biomedical Research), Paul V. Thomas ICCVAM as a permanent interagency • Submission of a proposal to
(NIAID), Marie L. Pancera (NIAID), committee of the National Institute of develop a performance-based test
Mallika Sastry (NIAID), Cinque Soto Environmental Health Sciences (NIEHS) guideline for defined approaches to skin
(NIAID), Guillaume B.E. Stewart-Jones under NICEATM. ICCVAM’s mission is sensitization testing and assessment to
(NIAID), Yongping Yang (NIAID), Li Ou to facilitate development, validation, the Organisation for Economic Co-
(NIAID), Ulrich Baxa (NCI), Emily and regulatory acceptance of new and operation and Development (OECD) by
Rundlet (NIAID), Joseph Van Galen revised regulatory test methods that partners in the International
(NIAID). reduce, refine, or replace the use of Cooperation on Alternative Test
daltland on DSKBBV9HB2PROD with NOTICES
Publications: Joyce, M. Gordon, et al., animals in testing while maintaining Methods in 2016. The proposal was
Nature structural & molecular biology, and promoting scientific quality and the approved as part of the OECD workplan
23.9 (2016): 811; PMID: 27478931. protection of human health, animal in 2017.
Intellectual Property: HHS Reference health, and the environment. • Launch of the Integrated Chemical
Number E–064–2016: U.S. Patent A provision of the ICCVAM Environment, a publicly accessible
Application No. 62/314,946 filed 03/29/ Authorization Act states that ICCVAM online resource developed to provide
2016; PCT Application Number PCT/ shall prepare ‘‘reports to be made high-quality curated data and
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Document Created: 2018-11-06 10:38:19
Document Modified: 2018-11-06 10:38:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Vince Contreras, Ph.D., 240-669-2823; [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. | |
| FR Citation | 83 FR 38716 |
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