83 FR 58266 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 223 (November 19, 2018)

Page Range		58266-58266
FR Document		2018-25189

The invention listed below is owned by an agency of the U.S. Government and is available for licensing.

Federal Register, Volume 83 Issue 223 (Monday, November 19, 2018)

[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Page 58266]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25189]


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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.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing.

FOR FURTHER INFORMATION CONTACT: Dr. Vince Contreras, 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to receive copies of unpublished patent applications.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.

Optimized Variants of the Broadly Neutralizing HIV-1 gp41 Antibody, 
10E8

Description of Technology

    Scientists at the National Institute of Allergy and Infectious 
Diseases (NIAID) recently discovered a human neutralizing antibody, 
10E8, that binds to the GP41 protein of HIV-1 and prevents infection by 
HIV-1. 10E8 potently neutralizes up to 98% of genetically diverse HIV-1 
strains.
    By engineering the 10E8 antibody, NIAID scientists have improved 
the properties of 10E8 that affect manufacturability, such as 
solubility, while preserving its neutralizing breadth and potency.
    10E8 variants are useful for passive protection from infection, as 
therapeutics, and as a tool for vaccine development.
    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

     Passive protection to prevent HIV infection
     Passive protection to prevent mother-to-infant HIV 
transmission
     Gene-based vectors for anti-gp41 antibody expression
     Therapeutics for elimination of HIV infected cells that 
are actively producing virus

Competitive Advantages

     Among the most potent and broadly neutralizing human 
antibodies isolated to date
     Broad reactivity and high affinity to most HIV-1 strains
     Improved manufacturability relative to the natural 10E8 
antibody

Development Stage

     In vivo data available (animal)
    Inventors: Peter D. Kwong (NIAID), Young Do Kwon (NIAID), Ivelin S. 
Georgiev (NIAID), Gilad A. Ofek (NIAID), Baoshan Zhang (NIAID), Krisha 
McKee (NIAID), John Mascola (NIAID), Gwo-Yu Chuang (NIAID), Sijy O'Dell 
(NIAID), Robert Bailer (NIAID), Mark Louder (NIAID), Mangaiarkarasi 
Asokan (NIAID), Richard Schwartz (NIAID), Jonathan Cooper (NIAID), 
Kevin Carlton (NIAID), Michael Bender (NIAID), Mark Connors (NIAID), 
Amarendra Pegu (NIAID), Lisa Kueltzo (NIAID), Tatyana Gindin (Columbia 
University), and Lawrence Shapiro (Columbia University).
    Publications: Kwon, Y.D. et al. (2016) Optimization of the 
Solubility of HIV-1-Neutralizing Antibody 10E8 through Somatic 
Variation and Structure-Based Design. J Virol. 90(13): 5899-914. [PMID: 
27053554]
    Intellectual Property: HHS Reference Number E-133-2015 includes 
Patent Cooperation Treaty Application Number PCT/US2016/060390 filed 
November 3, 2016; Canadian Patent Application Number 3003878 filed May 
1, 2018; China Patent Application Number TBD filed May 1, 2018; 
European Patent Application Number 16801639.2 filed June 1, 2018; India 
Patent Application Number 20187016184 filed 30 April 2018; U.S. Patent 
Application Number 15/772,443 filed 30 April 2018; South Africa Patent 
Application Number 2018/02875 filed 2 May 2018; Australia Patent 
Application Number 2016349392 filed 4 May 2018.
    Related Intellectual Property: HHS Reference Number E-253-2011.
    Licensing Contact: Dr. Vince Contreras, 240-669-2823; 
vince.contreras@nih.gov.

    Dated: November 7, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-25189 Filed 11-16-18; 8:45 am]
BILLING CODE 4140-01-P

58266 Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices

qualifications and performance, and the Fishers Lane, Rockville, MD, 20852; tel. Connors (NIAID), Amarendra Pegu
competence of individual investigators, 301–496–2644. A signed Confidential (NIAID), Lisa Kueltzo (NIAID), Tatyana
the disclosure of which would Disclosure Agreement will be required Gindin (Columbia University), and
constitute a clearly unwarranted to receive copies of unpublished patent Lawrence Shapiro (Columbia
invasion of personal privacy. applications. University).
Name of Committee: Division of Intramural SUPPLEMENTARY INFORMATION: Publications: Kwon, Y.D. et al. (2016)
Research Board of Scientific Counselors, Technology description follows. Optimization of the Solubility of HIV-1-
NIAID. Neutralizing Antibody 10E8 through
Date: December 10–12, 2018. Optimized Variants of the Broadly Somatic Variation and Structure-Based
Time: 8:00 a.m. to 10:00 a.m. Neutralizing HIV–1 gp41 Antibody, Design. J Virol. 90(13): 5899–914.
Agenda: To review and evaluate personal 10E8 [PMID: 27053554]
qualifications and performance, and
Description of Technology Intellectual Property: HHS Reference
competence of individual investigators.
Place: National Institutes of Health, Scientists at the National Institute of Number E–133–2015 includes Patent
Building 50, 50 Center Drive, Bethesda, MD Allergy and Infectious Diseases (NIAID) Cooperation Treaty Application Number
20892. recently discovered a human PCT/US2016/060390 filed November 3,
Contact Person: Steven M. Holland, MD, neutralizing antibody, 10E8, that binds 2016; Canadian Patent Application
Ph.D., Chief, Laboratory of Clinical Infectious Number 3003878 filed May 1, 2018;
to the GP41 protein of HIV–1 and
Diseases, National Institutes of Health/ China Patent Application Number TBD
NIAID, Hatfield Clinical Research Center, prevents infection by HIV–1. 10E8
potently neutralizes up to 98% of filed May 1, 2018; European Patent
Bethesda, MD 20892–1684, 301–402–7684,
sholland@mail.nih.gov. genetically diverse HIV–1 strains. Application Number 16801639.2 filed
By engineering the 10E8 antibody, June 1, 2018; India Patent Application
In the interest of security, NIH has
instituted stringent procedures for entrance NIAID scientists have improved the Number 20187016184 filed 30 April
onto the NIH campus. All visitor vehicles, properties of 10E8 that affect 2018; U.S. Patent Application Number
including taxicabs, hotel, and airport shuttles manufacturability, such as solubility, 15/772,443 filed 30 April 2018; South
will be inspected before being allowed on while preserving its neutralizing Africa Patent Application Number 2018/
campus. Visitors will be asked to show one breadth and potency. 02875 filed 2 May 2018; Australia
form of identification (for example, a 10E8 variants are useful for passive Patent Application Number 2016349392
government-issued photo ID, driver’s license, filed 4 May 2018.
protection from infection, as
or passport) and to state the purpose of their Related Intellectual Property: HHS
visit. therapeutics, and as a tool for vaccine
development. Reference Number E–253–2011.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology, This technology is available for Licensing Contact: Dr. Vince
and Transplantation Research; 93.856, licensing for commercial development Contreras, 240–669–2823;
Microbiology and Infectious Diseases in accordance with 35 U.S.C. 209 and 37 vince.contreras@nih.gov.
Research, National Institutes of Health, HHS) CFR part 404. Dated: November 7, 2018.
Dated: November 14, 2018. Potential Commercial Applications Suzanne M. Frisbie,
Natasha M. Copeland, Deputy Director, Technology Transfer and
• Passive protection to prevent HIV
Program Analyst, Office of Federal Advisory Intellectual Property Office, National Institute
infection of Allergy and Infectious Diseases.
Committee Policy.
• Passive protection to prevent
[FR Doc. 2018–25190 Filed 11–16–18; 8:45 am] [FR Doc. 2018–25189 Filed 11–16–18; 8:45 am]
mother-to-infant HIV transmission
BILLING CODE 4140–01–P • Gene-based vectors for anti-gp41 BILLING CODE 4140–01–P

antibody expression
• Therapeutics for elimination of HIV DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND infected cells that are actively
HUMAN SERVICES HUMAN SERVICES
producing virus
National Institutes of Health Competitive Advantages National Institutes of Health

Government-Owned Inventions; • Among the most potent and broadly National Human Genome Research
Availability for Licensing neutralizing human antibodies isolated Institute; Notice of Closed Meeting
to date
AGENCY: National Institutes of Health, • Broad reactivity and high affinity to Pursuant to section 10(d) of the
HHS. most HIV–1 strains Federal Advisory Committee Act, as
ACTION: Notice. • Improved manufacturability amended, notice is hereby given of a
relative to the natural 10E8 antibody meeting of National Advisory Council
SUMMARY: The invention listed below is for Human Genome Research.
owned by an agency of the U.S. Development Stage The meeting will be closed to the
Government and is available for • In vivo data available (animal) public in accordance with the
licensing. Inventors: Peter D. Kwong (NIAID), provisions set forth in sections
FOR FURTHER INFORMATION CONTACT: Dr. Young Do Kwon (NIAID), Ivelin S. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Vince Contreras, 240–669–2823; Georgiev (NIAID), Gilad A. Ofek as amended. The grant applications and
vince.contreras@nih.gov. Licensing (NIAID), Baoshan Zhang (NIAID), Krisha the discussions could disclose
khammond on DSK30JT082PROD with NOTICES

information and copies of the U.S. McKee (NIAID), John Mascola (NIAID), confidential trade secrets or commercial
patent application listed below may be Gwo-Yu Chuang (NIAID), Sijy O’Dell property such as patentable material,
obtained by communicating with the (NIAID), Robert Bailer (NIAID), Mark and personal information concerning
indicated licensing contact at the Louder (NIAID), Mangaiarkarasi Asokan individuals associated with the grant
Technology Transfer and Intellectual (NIAID), Richard Schwartz (NIAID), applications, the disclosure of which
Property Office, National Institute of Jonathan Cooper (NIAID), Kevin Carlton would constitute a clearly unwarranted
Allergy and Infectious Diseases, 5601 (NIAID), Michael Bender (NIAID), Mark invasion of personal privacy.

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Document Created: 2018-11-17 02:46:27
Document Modified: 2018-11-17 02:46:27

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		Dr. Vince Contreras, 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 58266

83 FR 58266 - Government-Owned Inventions; Availability for Licensing

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 223 (November 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health