[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)]
[Notices]
[Pages 50667-50668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21762]


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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 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to receive copies of unpublished patent applications.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.

HIV-1 Env Fusion Peptide Immunogens and Their Use

    Description of Technology: Millions of people are infected with 
HIV-1 worldwide, and 2.5 to 3 million new infections have been 
estimated to occur yearly. Although effective antiretroviral therapies 
are available, millions succumb to AIDS every year, especially in Sub-
Saharan Africa, underscoring the need to develop measures to prevent 
the spread of this disease.
    HIV-1 is an enveloped virus, which hides from humoral recognition 
behind a wide array of protective mechanisms. During infection, the 
major envelope protein of HIV-1 is cleaved by host cell proteases into 
two smaller versions (gp120 and gp41). Together gp120 and gp41 make up 
the HIV-1 Env spike, which is a target for neutralizing antibodies. It 
is believed that immunization with an effective immunogen based on the 
HIV-1 Env glycoprotein can elicit a neutralizing response, which may be 
protective against HIV-1 infection.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases used knowledge from the 
crystal structure of an HIV-1 neutralizing antibody, VRC34.01, in 
complex with its epitope on the HIV-1 Env trimer, to develop novel 
immunogens. HIV-1 uses a fusion peptide, located at the N-terminus of 
the gp41 subunit, to fuse with a target cell to infect the cell. The 
crystal structure revealed the epitope recognized by VRC34.01 to be 
composed primarily of the exposed 8 residues of the fusion peptide at 
the N-terminus of the gp41 subunit. Researchers designed fusion peptide 
immunogens that were comprised of the exposed residues of the fusion 
peptide coupled to highly immunogenic carrier proteins to focus the 
immune response to this conserved site of vulnerability. The fusion 
peptide can be displayed on scaffold proteins and--when coupled to HIV-
1 Env trimer boosts--has the potential to elicit antibodies capable of 
neutralizing diverse HIV-1 strains in mice, guinea pigs and rhesus 
macaques, and might therefore serve as the basis for an effective HIV 
vaccine.
    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:

HIV-1 vaccine

    Competitive Advantages:

Potential to be a broadly neutralizing HIV-1 vaccine

    Development Stage: In vivo testing (rodents and non-human 
primates).
    Inventors: Peter Kwong (NIAID), John Mascola (NIAID), Kai Xu 
(NIAID), Rui Kong (NIAID), Tongqing Zhou (NIAID), Li Ou (NIAID), Cheng 
Cheng (NIAID), Wing-Pui Kong (NIAID), Gwo-Yu Chuang (NIAID), Kevin Liu 
(NIAID), Michael Gordon Joyce (NIAID), Yongping Yang (NIAID), Baoshan 
Zhang (NIAID)
    Publications:

(a) Kong, Rui, et al. ``Fusion peptide of HIV-1 as a site of 
vulnerability to

[[Page 50668]]

neutralizing antibody.'' Science 352.6287 (2016): 828-833.
(b) Xu, Kai, et al. ``Epitope-based vaccine design yields fusion 
peptide-directed antibodies that neutralize diverse strains of HIV-1.'' 
Nature Medicine 24, 857-867 (2018).

    Intellectual Property: HHS Reference Number E-279-2016 includes 
U.S. Provisional Patent Application Number 62/403,266 filed 10/03/2016 
and PCT Application Number PCT/US2017/054959 filed 10/03/2017 
(pending).
    Licensing Contact: Barry Buchbinder, Ph.D., 240-627-3678; 
[email protected]

    Dated: September 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-21762 Filed 10-5-18; 8:45 am]
 BILLING CODE 4140-01-P