[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Page 26406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8895]


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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.

Influenza Vaccines and Antiviral Agents

    Description of Technology: The subject invention offers candidate 
DNA vaccines to target H5N1, H1N1, H3N2 and other subtypes of 
influenza. These candidates are designed primarily to elicit 
neutralizing antibodies. The candidate vaccines express hemagglutinin 
(H/HA) or neuramidase (N/NA) protein that has been codon optimized and/
or modified at the protease cleavage site. The modified genes could be 
used in DNA vaccines, in viral vectors, recombinant proteins/particles 
or combination. The studies use proprietary expression systems that 
increase protein expression relative to commonly used alternatives. 
This invention potentially provides a vaccine strategy for controlling 
influenza epidemics, including avian flu, should it cross over to 
humans; the 1918 strain of flu; and seasonal flu strains. In addition, 
this invention is designed to lead to a combination vaccine to provide 
a broadly protective vaccine. The incorporation of specific cleavage 
site types to facilitate preparation of pseudotypes from a variety of 
strains is an important aspect of this invention.
    In addition, HA pseudotyped lentiviral vectors are being tested to 
screen for neutralizing abs in patients and to screen for diagnostic 
and therapeutic monoclonal abs.
    Applications and Advantages: Influenza vaccine for pandemic or 
epidemic application; Potential for combination vaccine for broad 
protection, removing need for seasonal strain monitoring; DNA vaccines 
are easy to produce and store; No risk of reversion to pathogenic 
strain as with live-attenuated virus vaccines.
    Development Status Highlights: Phase I clinical trials planned for 
select candidates; DNA vaccine encoding 1918 influenza virus HA protein 
protects mice against lethal viral challenge; Codon optimized for 
expression in human cells.
    Inventors: Gary J. Nabel (VRC/NIAID), Wing-pui Kong (VRC/NIAID), 
Zhi-yong Yang (VRC, NIAID), et al.
    Publication: Certain aspects of this technology were published in 
WP Kong et al. Protective immunity to lethal challenge of the 1918 
pandemic influenza virus by vaccination. Proc Natl Acad Sci USA. 2006 
Oct 24;103(43):15987-15991. Epub 2006 Oct 16, doi: 10.1073/
pnas.0607564103.
    Patent Status: U.S. Provisional Application No. 60/774,923 filed 16 
Feb 2006 (HHS Reference No. E-116-2006/0-US-01) and PCT Application No. 
PCT/US2007/004506 filed 16 Feb 2007 (influenza) (HHS Reference No. E-
116-2006/1-PCT-01); U.S. Patent No. 7,094,598 issued 22 Aug 2006 (CMV/
R) (HHS Reference No. E-241-2001/1-US-01) and associated foreign 
rights.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].

Enhanced, Targeted Delivery for DNA Vaccines

    Description of Technology: Available for licensing from the NIH is 
a fusion protein for enhanced gene delivery. Exemplary proteins for 
achieving this improvement comprise an adenovirus serotype 5 fiber, 
penton base and core protein V fused to the DNA binding domain of HMG. 
In vitro studies have shown the effectiveness of the chimeric protein-
DNA vaccine co-administration by an increase in uptake of ten to twenty 
fold. In particular, the plasmid with the chimeric core protein V was 
delivered efficiently to dendritic cells (DC) as well as 293T cells. 
The utilization of this chimeric protein could further enhance the 
immune response elicited by DNA vaccines.
    Potential Applications: Improved DNA vaccine delivery and uptake.
    Inventors: Gary J. Nabel and Wataru Akahata (VRC/NIAID).
    Patent Status: U.S. Provisional Application No. 60/737,896 filed 18 
Nov 2005 (HHS Reference No. E-043-2006/0-US-01); U.S. Provisional 
Application No. 60/795,529 filed 26 Apr 2006 (HHS Reference No. E-043-
2006/1-US-01); PCT Application No. PCT/US2006/044525 filed 20 Nov 2006 
(HHS Reference No. E-043-2006/3-PCT-01)
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].

    Dated: April 30, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-8895 Filed 5-8-07; 8:45 am]
BILLING CODE 4140-01-P