[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65754-65756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22821]


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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.

Inactivation of Enveloped Viruses and Tumor Cells for Infectious 
Disease and Cancer Vaccines

    Description of Invention: The current technology describes the 
inactivation of viruses, parasites, and tumor cells by the hydrophobic 
photoactivatable compound 1,5-iodoanpthylazide (INA). This non-toxic 
compound will diffuse into the lipid bilayer of biological membranes 
and upon irradiation with light will bind to proteins and lipids in 
this domain, thereby inactivating fusion of enveloped viruses with 
their corresponding target cells. Furthermore, the selective binding of 
INA to protein domains in the lipid bilayer preserves the structural 
integrity and therefore immunogenicity of proteins on the exterior of 
the inactivated virus. This technology is universally applicable to 
other microorganisms that are surrounded by biological membranes like 
parasites and tumor cells. The broad utility of the subject technology 
has been demonstrated using influenza virus, HIV, SIV, Ebola and equine 
encephalitis virus (VEE) as representative examples. The inactivation 
approach for vaccine development presented in this technology provides 
for a safe, non-

[[Page 65755]]

infectious formulation for vaccination against the corresponding agent. 
Vaccination studies demonstrated that mice immunized with INA 
inactivated influenza, ebola and VEE mounted a protective immune 
response against lethal doses of the corresponding virus. A second 
technology for inactivating HIV and other retroviruses by inactivation 
of zinc fingers is described in E-174-1993/1,/2.
    Applications: Vaccines against enveloped viruses, including 
influenza and HIV; Cancer vaccines.
    Development Status: Animal data (mouse) available for influenza.
    Inventors: Yossef Raviv et al. (NCI).
    Publication: Y Raviv et al. Inactivation of retroviruses with 
preservation of structural integrity by targeting the hydrophobic 
domain of the viral envelope. J Virol. 2005 Oct;79(19):12394-12400.
    Patent Status:
    PCT application, serial number PCT/US2005/009559 (publication 
number WO 2005/093049), filed 22 Mar 2005 claiming priority to 22 Mar 
2004; National Stage applications pending in Australia, Canada, China, 
Europe, India, and U.S. (HHS Reference No. E-303-2003/0).
    PCT application, serial number PCT/US2007/007338, filed 23 Mar 2007 
claiming priority to 24 Mar 2006 (HHS Reference No. E-135-2006/1-PCT-
01; influenza-specific inactivation).
    U.S. Patent No. 6,001,555, issued 14 Dec 1999 (HHS Reference No. E-
174-1993/1); PCT application, serial number PCT/US95/11915 (publication 
number WO 96/09406), filed 19 Sept 1995 claiming priority to 23 Sept 
1994, now EP patent number 0782632, issued 16 April 2003 in Italy, 
Belgium, Switzerland, Germany, and United Kingdom (HHS Reference No. E-
174-1993/2; second HIV inactivation technology).
    Licensing Contacts:
    For HHS Reference Nos. E-303-2003 and E-135-2006--Susan Ano, PhD; 
phone: (301) 435-5515; e-mail: [email protected].
    For HHS Reference No. E-174-1993--Sally Hu, PhD, MBA; phone: (301) 
435-5606; e-mail: [email protected].
    Collaborative Research Opportunity: The National Cancer Institute's 
Membrane Structure and Function Section is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize non-infectious 
formulation for vaccination. Please contact John D. Hewes, Ph.D. at 
301-435-3121 or [email protected] for more information.

Monoclonal Antibodies That Bind or Neutralize Dengue Virus

    Description of Invention: Among the arthropod-borne flaviviruses, 
the four dengue virus serotypes, dengue type 1 virus (DENV-1), dengue 
type 2 virus (DENV-2), dengue type 3 virus (DENV-3), and dengue type 4 
virus (DENV-4) are most important in terms of human morbidity and 
geographic distribution. Dengue viruses cause dengue outbreaks and 
major epidemics in most tropical and subtropical areas where Aedes 
albopictus and Aedes aegypti mosquitoes are abundant. Dengue infection 
produces fever, rash, and joint pain in humans. A more severe and life-
threatening form of dengue, characterized by hemorrhagic fever and 
hemorrhagic shock, has occurred with increasing frequency in Southeast 
Asia and Central and South America, where all four dengue virus 
serotypes circulate. A safe and effective vaccine against dengue is 
currently not available. Passive immunization with monoclonal 
antibodies from non-human primates or humans represents a possible 
alternative to vaccines for prevention of illness caused by dengue 
virus.
    The application claims monoclonal antibodies that bind or 
neutralize dengue type 1, 2, 3, and/or 4 viruses. The application also 
claims fragments of such antibodies retaining dengue virus-binding 
ability, fully human or humanized antibodies retaining dengue virus-
binding ability, and pharmaceutical compositions including such 
antibodies. The application also claims isolated nucleic acids encoding 
the antibodies of the invention. Additionally, application claims 
prophylactic, therapeutic, and diagnostic methods employing the 
antibodies and nucleic acids of the invention.
    Application: Prophylaxis against dengue serotypes 1, 2, 3 and 4.
    Development Status: Antibodies have been synthesized and 
preclinical studies have been performed.
    Inventors: Ching-Juh Lai and Robert Purcell (NIAID).
    Publications: The antibodies are further described in:
    1. R Men et al. Identification of chimpanzee Fab fragments by 
repertoire cloning and production of a full-length humanized 
immunoglobulin G1 antibody that is highly efficient for neutralization 
of dengue type 4 virus. J Virol. 2004 May;78(9):4665-4674.
    2. AP Goncalvez et al. Chimpanzee Fab fragments and a derived 
humanized immunoglobulin G1 antibody that efficiently cross-neutralize 
dengue type 1 and type 2 viruses. J Virol. 2004 Dec;78(23):12910-12918.
    3. AP Goncalvez et al. Epitope determinants of a chimpanzee Fab 
antibody that efficiently cross-neutralizes dengue type 1 and type 2 
viruses map to inside and in close proximity to fusion loop of the 
dengue type 2 virus envelope glycoprotein. J Virol. 2004 
Dec;78(23):12919-12928.
    4. AP Goncalvez et al. Monoclonal antibody-mediated enhancement of 
dengue virus infection in vitro and in vivo and strategies for 
prevention. Proc Natl Acad Sci U S A. 2007 May 29;104(22):9422-9427.
    Patent Status: U.S. Patent Application No. 10/582,006 filed 07 Jun 
2006 (HHS Reference No. E-066-2003/5-US-02); Canadian Patent 
Application No. 2548808 filed 03 Dec 2004 (HHS Reference No. E-066-
2003/5-CA-03).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The NIAID Laboratory of 
Infectious Diseases is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please contact Ching-Juh 
Lai at 301-594-2422 for more information.

Novel Non-Nucleoside Agents for the Inhibition of HIV Reverse 
Transcriptase for the Treatment of HIV-1

    Description of Invention: Despite recent developments in drug and 
compound design to combat the human immunodeficiency virus (HIV), there 
remains a need for a potent, non-toxic compound that is effective 
against wild type reverse transcriptase (RT) as well as RTs that have 
undergone mutations and thereby become refractory to commonly used 
anti-HIV compounds. There are two major classes of RT inhibitors. The 
first comprises nucleoside analogues, which are not specific for HIV-RT 
and are incorporated into cellular DNA by host DNA polymerases. 
Nucleoside analogues can cause serious side effects and have resulted 
in the emergence of drug resistance viral strains that contain 
mutations in their RT. The second major class of RT inhibitors 
comprises non-nucleoside RT inhibitors (NNRTIs) that do not act as DNA 
chain terminators and are highly specific for HIV-RT. This technology 
is a novel class of NNRTIs (substituted benzimidazoles) effective in 
the inhibition of HIV-RT wild type as well as against variant HIV 
strains resistant to many non-nucleoside

[[Page 65756]]

inhibitors. These NNRTIs are highly specific for HIV-1 RT and do not 
inhibit normal cellular polymerases, resulting in lower cytotoxicity 
and fewer side effects that the nucleoside analogues, such as AZT. This 
novel class of compounds could significantly improve the treatment of 
HIV by increasing compliance with therapy.
    Inventors: Christopher A. Michejda, Marshall Morningstar, Thomas 
Roth (NCI).
    Patent Status: U.S. Patent No. 6,369,235 issued 09 Apr 2002 (HHS 
Reference No. E-076-1997/1-US-01); U.S. Patent No. 6,894,068 issued 17 
May 2005 (HHS Reference No. E-076-1997/1-US-02).
    Licensing Contact: Sally Hu, PhD., MBA; 301/435-5606; 
[email protected].

    Dated: November 9, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-22821 Filed 11-21-07; 8:45 am]
BILLING CODE 4140-01-P