Government-Owned Inventions; Availability for Licensing, 60879 [2018-25787]

Download as PDF Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Frank S. De Silva, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room #3E72A, National Institutes of Health/ NIAID, 5601 Fishers Lane, MSC 9823, Rockville, MD 20892–9823, (240) 669–5023, fdesilva@niaid.nih.gov. (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: November 20, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–25789 Filed 11–26–18; 8:45 am] BILLING CODE 4140–01–P 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: Barry Buchbinder, Ph.D., 240–627– 3678; barry.buchbinder@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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.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. amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: Recombinant HIV–1 Envelope Proteins and Their Use Description of Technology An effective human immunodeficiency virus type 1 (HIV–1) vaccine has long been sought to contend VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 with the Acquired Immunodeficiency Syndrome (AIDS) pandemic. One approach researchers have taken to elicit broadly neutralizing antibodies against HIV–1 is to stabilize the structurally flexible HIV–1 envelope (Env) trimer. Researchers stabilized the Env trimer in a conformation that displays predominantly broadly neutralizing epitopes and few nonneutralizing epitopes. Currently, BG505 DS–SOSIP is a leading vaccine candidate with the desired conformation and antigenicity. Ideally, to be useful as a vaccine, such a conformationally fixed Env immunogen should have high thermostability and should remain in the desired antigenic state, even in the presence of CD4, a glycoprotein found on the surface of immune cells. Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) undertook efforts to improve the properties of BG505 DS–SOSIP for use as a vaccine. The VRC researchers introduced three additional mutations to further stabilize BG505 DS–SOSIP in the vaccine-preferred prefusion-closed conformation and refer to the engineered BG505 DS–SOSIP as BG505 DS–SOSIP.3mut. Experiments showed that these modifications conferred improved thermostability that will allow easier transport and storage of BG505 DS–SOSIP.3mut compared to BG505 DS–SOSIP. In addition, BG505 DS–SOSIP.3mut has lower antigenicity toward non/weak neutralizing antibodies compared to BG505 DS– SOSIP, which suggests that it could potentially elicit higher neutralization titer by targeting only broadly neutralizing antibodies. With improved antigenicity and stability, this version may have utility as an HIV–1 immunogen or in other antigen-specific contexts, such as for use with B-cell probes. 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 • Vaccine—to elicit potent neutralizing antibodies against the HIV– 1 Env glycoprotein. • Probes—to identify broad and potent HIV–1-neutralizing antibodies. Competitive Advantages Compared to previous engineered Env trimer versions: • 300-fold reduction in CD4-binding affinity. • Reduced binding affinity to ineffective HIV–1 antibodies. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 60879 • Increase in melting temperature (10 degrees over BG505 SOSIP). Development Stage: In vivo testing (rodents). Inventors: Peter Kwong (NIAID), John Mascola (NIAID), Gwo-Yu Chuang (NIAID), Cheng Cheng (NIAID), Hui Geng (NIAID), Yongping Yang (NIAID) and Jeffrey C. Boyington (NIAID). Intellectual Property: HHS Reference Number E–240–2017 includes U.S. Provisional Patent Application Number 62/579,973 filed 10/16/2017. Related Intellectual Property: HHS Reference Number E–187–2014 includes U.S. Provisional Patent Application Number 62/046,059 filed 9/4/2014, U.S. Provisional Patent Application Number 62/136,480 filed 3/21/2015, PCT Application No. PCT/US2015/048729 filed 9/4/2015, US Patent Application 15/508,885 filed 3/3/2017, EP Patent Application Number 15766697.5 filed 3/29/2017. Licensing Contact: Barry Buchbinder, Ph.D., 240–627–3678; barry.buchbinder@nih.gov. Dated: November 14, 2018. Suzanne M. Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2018–25787 Filed 11–26–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings 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 grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE I (P50) Review. Date: January 29–30, 2019. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20850. E:\FR\FM\27NON1.SGM 27NON1

Agencies

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Page 60879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25787]


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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: Barry Buchbinder, Ph.D., 240-627-3678; 
[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.

Recombinant HIV-1 Envelope Proteins and Their Use

Description of Technology

    An effective human immunodeficiency virus type 1 (HIV-1) vaccine 
has long been sought to contend with the Acquired Immunodeficiency 
Syndrome (AIDS) pandemic.
    One approach researchers have taken to elicit broadly neutralizing 
antibodies against HIV-1 is to stabilize the structurally flexible HIV-
1 envelope (Env) trimer. Researchers stabilized the Env trimer in a 
conformation that displays predominantly broadly neutralizing epitopes 
and few non-neutralizing epitopes. Currently, BG505 DS-SOSIP is a 
leading vaccine candidate with the desired conformation and 
antigenicity.
    Ideally, to be useful as a vaccine, such a conformationally fixed 
Env immunogen should have high thermostability and should remain in the 
desired antigenic state, even in the presence of CD4, a glycoprotein 
found on the surface of immune cells.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) undertook efforts 
to improve the properties of BG505 DS-SOSIP for use as a vaccine. The 
VRC researchers introduced three additional mutations to further 
stabilize BG505 DS-SOSIP in the vaccine-preferred prefusion-closed 
conformation and refer to the engineered BG505 DS-SOSIP as BG505 DS-
SOSIP.3mut. Experiments showed that these modifications conferred 
improved thermostability that will allow easier transport and storage 
of BG505 DS-SOSIP.3mut compared to BG505 DS-SOSIP. In addition, BG505 
DS-SOSIP.3mut has lower antigenicity toward non/weak neutralizing 
antibodies compared to BG505 DS-SOSIP, which suggests that it could 
potentially elicit higher neutralization titer by targeting only 
broadly neutralizing antibodies. With improved antigenicity and 
stability, this version may have utility as an HIV-1 immunogen or in 
other antigen-specific contexts, such as for use with B-cell probes.
    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

     Vaccine--to elicit potent neutralizing antibodies against 
the HIV-1 Env glycoprotein.
     Probes--to identify broad and potent HIV-1-neutralizing 
antibodies.

Competitive Advantages

    Compared to previous engineered Env trimer versions:
     300-fold reduction in CD4-binding affinity.
     Reduced binding affinity to ineffective HIV-1 antibodies.
     Increase in melting temperature (10 degrees over BG505 
SOSIP).
    Development Stage: In vivo testing (rodents).
    Inventors: Peter Kwong (NIAID), John Mascola (NIAID), Gwo-Yu Chuang 
(NIAID), Cheng Cheng (NIAID), Hui Geng (NIAID), Yongping Yang (NIAID) 
and Jeffrey C. Boyington (NIAID).
    Intellectual Property: HHS Reference Number E-240-2017 includes 
U.S. Provisional Patent Application Number 62/579,973 filed 10/16/2017.
    Related Intellectual Property: HHS Reference Number E-187-2014 
includes U.S. Provisional Patent Application Number 62/046,059 filed 9/
4/2014, U.S. Provisional Patent Application Number 62/136,480 filed 3/
21/2015, PCT Application No. PCT/US2015/048729 filed 9/4/2015, US 
Patent Application 15/508,885 filed 3/3/2017, EP Patent Application 
Number 15766697.5 filed 3/29/2017.
    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected].

    Dated: November 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-25787 Filed 11-26-18; 8:45 am]
 BILLING CODE 4140-01-P
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