[Federal Register: March 7, 2007 (Volume 72, Number 44)]
[Notices]
[Page 10228-10229]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr07-116]
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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;
anos@mail.nih.gov
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; HuS@mail.nih.gov.
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 hewesj@mail.nih.gov 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