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[Federal Register Volume 72, Number 44 (Wednesday, March 7, 2007)]
[Notices]
[Pages 10228-10229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3959]

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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, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 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.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Novel System for HIV-1 Vaccine Development

    Description of Technology: The available technologies describe 
specific immunogenic peptides, peptide modifications and methods for 
identifying additional immunogens against HIV-1 surface proteins, gp120 
and gp41. Additionally, detailed methods for use of the described 
immunogenic peptides in the development of vaccines and diagnostics for 
HIV-1 are disclosed. The current technologies further include a 
comprehensive system for immunogen design, comprising in silico design 
coupled to feedback from X-ray crystallography, antigenic analysis, and 
immunization.
    The described methodology demonstrates how to transplant a given 
HIV-1 epitope recognized by broadly neutralizing antibodies into an 
appropriate scaffold, while preserving its structure and antigenicity. 
Conservation of the three dimensional structure may lead to the 
generation of antibodies with broadly neutralizing characteristics, 
similar to the template antibody. Such epitope-transplant scaffolds may 
serve as valuable diagnostics to identify specific serum reactivity 
against the target HIV-1 epitopes. The subject scaffolding technology 
may be applied to any virus for which a broadly neutralizing

[[Page 10229]]

antibody and its respective epitope has been characterized at the 
atomic-level.
    Applications:
    1. Immunogens that elicit immune responses to HIV-1.
    2. Efficient development of vaccines against HIV-1.
    3. Screening tool to isolate antibodies with activities similar to 
identified template antibody.
    Inventors: Peter D. Kwong et al. (NIAID)
    Publications:
    1. G Ofek, W Schief, J Guenaga, et al. Epitope-transplant 
scaffolds: Automated design, structural analysis, and antigenic 
characteristics. Manuscript in preparation (2007).
    2. T Zhou, L Xu, B Dey, AJ Hessell, DV Ryk, SH Xiang, X Yang, MY 
Zhang, MB Zwick, J Arthos, DR Burton, DS Dimitrov, J Sodroski, R Wyatt, 
GJ Nabel, PD Kwong. Structural definition of a conserved neutralization 
epitope on HIV-1 gp120. Nature. 2007 Feb 15;445(7129):732-737.
    3. DC Douek, PD Kwong, GJ Nabel. The rational design of an AIDS 
vaccine. Cell. 2006 Feb 24;124(4):677-681.
    4. G Ofek, M Tang, A Sambor, H Katinger, JR Mascola, R Wyatt, PD 
Kwong. Structure and mechanistic analysis of the anti-HIV-1 antibody 
2F5 in complex with its gp41 epitope. J Virol. 2004 Oct;78(19):10724-
10737.
    Patent Status:
    1. PCT Application No. PCT/US2005/016633 filed 13 May 2005, which 
published as WO 2005/111079 on 24 Nov 2005 (HHS Reference No. E-218-
2004/0-PCT-02), and National Stage filed in the U.S. on 26 Nov 2006 
(HHS Reference No. E-218-2004/0-US-03), entitled ``HIV Vaccine 
Immunogens and Immunization Strategies to Elicit Broadly-Neutralizing 
Anti-HIV-1 Antibodies Against the Membrane Proximal of HIV gp41''.
    2. PCT Application No. PCT/US2006/034681 filed 06 Sep 2006 (HHS 
Reference No. E-324-2005/3-PCT-01), entitled ``Conformationally 
Stabilized HIV Envelope Immunogens and Triggering HIV-1 Envelope to 
Reveal Cryptic V3-Loop Epitopes''
    3. PCT Application No. PCT/US2006/034882 filed 06 Sep 2006 (HHS 
Reference No. E-280-2006/1-PCT-01), entitled ``HIV gp120 Crystal 
Structure and Its Use to Identify Immunogens''
    4. U.S. Provisional Application No. 60/840,119 filed 25 Aug 2006 
(HHS Reference No. E-302-2006/0-US-01), entitled ``Epitope-Transplant 
Scaffolds and Their Use''
    Licensing Availability: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected]

CCR5-Specific Human Monoclonal Antibodies

    Description of Technology: The subject invention provides the 
composition claims related to anti-CCR5 monoclonal antibodies, their 
fusion protein, conjugates, derivatives, or fragments, DNA sequences 
encoding such antibodies, host cells containing such DNA sequences, as 
well as the methods to produce them recombinantly and their 
pharmacological composition.
    It has been demonstrated that the HIV co-receptor CCR5 plays an 
important role in virus entry. The subject antibodies exhibited 
neutralization activity against HIV-1 infection by binding to cell 
associated CCR5 in vitro. Moreover, subject antibodies have potentially 
lower immunogenicity and toxicity, because they are fully human 
antibodies. Therefore, subject anti-CCR5 antibodies have a potential as 
a therapeutic and/or prophylactic in combination with other HIV-1 
neutralizing antibodies and anti-retroviral drugs.
    Applications: HIV treatment and prevention.
    Development Status: In vitro data is available at this time.
    Inventors: Dimiter S. Dimitrov and Mei-Yun Zhang (NCI).
    Related Publications:
    1. C Pastori et al. Long-lasting CCR5 internalization by antibodies 
in a subset of long-term nonprogressors: A possible protective effect 
against disease progression. Blood. 2006 Jun 15;107(12):4825-4833.
    2. MY Zhang, B Vu, CC Huang, I Sidirov, V Choudhly, PD Kwong, DS 
Dimitrov. Identification of human monoclonal antibodies specific for 
CCR5 from an antibody library derived from HIV-infected long-term non-
progressors. Retrovirology. 2006 Dec 21;3 Suppl 1:S61.
    3. DS Dimitrov. Virus entry: molecular mechanisms and biomedical 
applications. Nat Rev Microbiol. 2004 Feb;2(2):109-122.
    Patent Status: U.S. Provisional Application No. 60/859,401 filed 15 
Nov 2006 (HHS Reference No. E-297-2006/0-US-01)
    Licensing Availability: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Sally Hu, Ph.D.; 301/435-5606; [email protected].
    Collaborative Research Opportunity: The NCI CCR Nanobiology Program 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize monoclonal antibodies. Please contact John D. Hewes, 
Ph.D. at 301-435-3121 or [email protected] for more information.

    Dated: February 28, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer National Institutes of Health.
[FR Doc. E7-3959 Filed 3-6-07; 8:45 am]
BILLING CODE 4140-01-P
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