[Federal Register Volume 72, Number 141 (Tuesday, July 24, 2007)]
[Notices]
[Pages 40315-40316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14205]



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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.

Rational HIV Therapeutic Design

    Description of Technology: This technology describes the structural 
nature of a highly conserved tyrosine-sulfate binding pocket on the 
HIV-1 gp120 envelope glycoprotein and the use of this information to 
design HIV-entry inhibitors that target it. The binding pocket was 
characterized by structural determinations of the N-terminus of CCR5 
with gp120 as well as of the complex of 412d (a tyrosine-sulfated 
antibody) with gp120 and CD4. The N terminus of CCR5, like the 412d 
antibody, is tyrosine-sulfated. In spite of structural differences 
between these molecules, gp120 recognizes both tyrosine-sulfated 
molecules in similar ways, indicating that this specificity can be 
exploited in the design of HIV-entry inhibitors.
    Applications: HIV therapeutic design.
    Inventors: Peter D. Kwong et al. (NIAID).
    Patent Status: U.S. Provisional Application No. 60/923,498 filed 13 
Apr 2007 (HHS Reference No. E-181-2007/0-US-01).
    Licensing Contact: Susan Ano, PhD; 301/435-5515; [email protected].
    Collaborative Research Opportunity: The Vaccine Research Center of 
the National Institute of Allergy and Infectious Diseases as well as 
the Laboratory of Bioorganic Chemistry of the National Institute of 
Diabetes and Digestive and Kidney Diseases are seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize tyrosine-
sulfated CCR5-based inhibitors of HIV-1 infection. Please contact Susan 
Ano for more information.

Viral Entry or Replication Inhibitors

    Description of Technology: The Tec family of tyrosine kinases, 
consisting of five family members Tec, Btk, Itk, Rlk, and BMX, are key 
regulators of signaling pathways of T lymphocytes. Many existing 
antiviral therapies rely on inhibition of viral replication, which 
leads to emergence or selection of resistant viruses. The current 
technology provides an alternative method for prevention or treatment 
of viral infection through administration of a Tec tyrosine kinase 
inhibitor. Such inhibitors can be siRNA, small chemical compounds, 
antisense or antibody. The current technology describes the inhibition 
of Itk (also known as Emt and Tsk) and the resulting decrease in HIV 
infectivity, replication, and transcription for exemplary purposes. 
Importantly, these inhibitors do not affect the expression of HIV co-
receptors CCR5, CXCR4, or CD4. The current technology could be used in 
combination with therapeutics that target virus replication.
    Application: Treatment of viral infection.
    Development Status: In vitro data available.
    Inventors: Julie Readinger et al. (NHGRI).
    Patent Status: U.S. Provisional Application No. 60/786,245 filed 29 
Mar 2006 (HHS Reference No. E-151-2006/0-US-01); PCT Application No. 
PCT/US2007/007711 filed 29 Mar 2007 (HHS Reference No. E-151-2006/1-
PCT-01).
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].

Dual Expression DNA Influenza Vaccine

    Description of Technology: The NIH is pleased to announce a single 
vector DNA vaccine against influenza as available for licensing. The 
single vector expresses both hemagglutinin (HA) and matrix (M) 
proteins, generating both humoral and cellular immune responses. The 
vaccine candidate completely protected mice against homologous virus 
challenge and significantly improved survival against heterologous 
virus challenge. A robust and reliable vaccine supply is widely 
recognized as critical for seasonal or pandemic influenza preparedness. 
The advantages offered by this vaccine make it an excellent candidate 
for further development.
    Advantages: (1) DNA vaccines easy to produce and store; (2) Vaccine 
candidate improved survival against heterologous virus challenge; (3) 
No risk of reversion to pathogenic strain as with live-attenuated virus 
vaccines; (4) Can be administered to immuno-compromised individuals, 
increasing potential market size; (5) HA and M proteins encoded by 
single vector, ensuring uniform delivery of immunogen; (6) More 
efficient to boost synergistic effects on both HA and M specific immune 
responses than a mixture of individual plasmids; (7) M protein not 
subject to antigenic drift, which allows advanced manufacturing and 
overcomes the need for strain monitoring; (8) DNA vaccines elicit 
cellular immune response, essential for efficient virus clearance.
    Application: Influenza vaccine.
    Inventors: Zhiping Ye et al. (CBER/FDA).
    Patent Status: U.S. Provisional Application No. 60/786,747 filed 27 
Mar 2006 (HHS Reference No. E-300-2005/0-US-01); PCT Application No. 
PCT/US2007/007529 filed 27 Mar 2007 (HHS Reference No. E-300-2005/1-
PCT-01).
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].
    Collaborative Research Opportunity: The CBER/FDA Division of Viral 
Products is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize the HA/M single vector DNA vaccine. Please contact 
Zhiping Ye at 301-435-5197 or [email protected] for more 
information.

Peptide Mimotope Candidates for Otitis Media Vaccine

    Description of Technology: This technology describes peptide 
mimotopes of lipooligosaccharides (LOS) from nontypeable Haemophilus 
influenzae (NTHi) and Moraxella catarrhalis that are suitable for 
developing novel vaccines against the respective pathogens, for which 
there are currently no licensed vaccines. The mimotopes not only 
immunologically mimic LOSs from NTHi and M. catarrhalis but will also 
bind to antibodies specific for the respective LOS. NTHi and M. 
catarrhalis are common pathogens that cause otitis media in children 
and lower respiratory tract infections in adults. The

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effectiveness of a vaccine could be increased by substitution of a LOS 
epitope with a peptide mimic. Preliminary experiments have shown that 
some of the mimic peptides conjugated to a carrier were as effective as 
their respective LOS-based vaccine in stimulating a humoral immune 
response in rabbits. A single consensus amino acid sequence was 
identified for M. catarrhalis, while four such sequences were 
identified for NTHi. Thus, the identified peptides are promising 
candidates for developing novel vaccines for NTHi or M. catarrhalis.
    Applications: Otitis media vaccine.
    Development Status: In vivo data available.
    Inventor: Xin-Xing Gu (NIDCD).
    Patent Status: U.S. Patent Application No. 11/187,419 filed 22 Jul 
2005 (HHS Reference No. E-344-2002/0-US-03).
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].
    Collaborative Research Opportunity: The NIDCD Vaccine Research 
Section is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize Peptide vaccines derived from LOS of NTHi or M. 
catarrhalis. Please contact Marianne Lynch, a technology development 
specialist, at 301-594-4094 or [email protected] for more 
information.

    Dated: July 17, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-14205 Filed 7-23-07; 8:45 am]
BILLING CODE 4140-01-P