[Federal Register Volume 74, Number 59 (Monday, March 30, 2009)]
[Notices]
[Pages 14141-14142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6936]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.

M2e Peptide Vaccine Against Influenza Virus

    Description of Technology: The invention offered here is a vaccine 
candidate that can potentially confer protection against many types of 
influenza. Current vaccines against influenza virus are comprised of 
inactivated virus or purified influenza virus proteins and are targeted 
primarily to induce neutralizing antibodies against the viral 
hemagglutinin (HA) protein. The virus can mutate or shift antigenic 
types of HA rapidly rendering the vaccines ineffective and thus the 
vaccine has to be evaluated yearly to predict next year's circulating 
strains for vaccine preparation. Unlike HA, the small M2 protein is 
highly conserved among different strains of influenza virus and thus 
vaccines based on the M2 protein have the potential to be effective 
against different strains of influenza. The current invention relates 
to peptide vaccines composed of the extracellular domain of the M2 
protein (M2e) conjugated to a carrier protein. In animals studies a 
mutant diphtheria toxin-M2e--conjugate induced high antibody levels to 
both vaccine components in mice.
    Applications:
     Preventative and therapeutic for influenza virus.
     Vaccine against seasonal and pandemic influenza virus 
strains.
    Advantages: Novel vaccine candidate with potential heterosubtypic 
protection.
    Development Status: In vitro and in vivo data can be provided upon 
request.
    Market: Influenza virus vaccines.
    Inventors: Mark A. Miller (FIC), Rachel Schneerson (NICHD), Joanna 
Kubler-Kielb (NICHD), John B. Robbins (NICHD), Zuzanna Biesova (NICHD), 
and Jerry Keith (NICHD).
    Patent Status: U.S. Provisional Application No. 61/089,384 filed 15 
Aug 2008 (HHS Reference No. E-304-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected].

Therapeutic HIV Vaccine and Associated Protocols

    Description of Technology: This technology describes a therapeutic 
HIV DNA vaccine to be administered to individuals who have previously 
experienced or are undergoing antiretroviral therapy (ART). The 
therapeutic DNA vaccine can also be administered in combination with a 
vector encoding an IL-15 and/or IL-15 receptor alpha (IL-15Ra) 
polypeptide. In primate studies, the technology was found to be 
particularly effective when the vaccine composition was administered by 
electroporation and expressed six (6) HIV antigens (including two (2) 
gag polypeptides and two (2) envelope polypeptides) and IL-15 and IL-
15Ra. The antigens are typically modified with a destabilizing 
sequence, a secretory polypeptide and/or a degradation signal. 
Successive administration up to as many as nine resulted in continual 
boost of the immune response against the encoded antigen. A potent 
immunotherapeutic vaccine as described here could be an important 
technology for the fight against HIV/AIDS.
    Applications: Therapeutic HIV DNA vaccines.
    Development Status: Primate data available.
    Inventor: Barbara Felber et al. (NCI).
    Patent Status:
    PCT Application No. PCT/US2008/51004 filed 14 Jan 2008, which 
published as WO 2008/089144 on 24 Jul 2008 (HHS Reference No. E-103-
2007/0-PCT-02); claiming priority to 12 Jan 2007.
    PCT Application No. PCT/US2007/000774 filed 12 Jan 2007, which 
published as WO 2007/084342 on 26 Jul 2007 (HHS Reference No. E-254-
2005/2-PCT-01); claiming priority to 13 Jan 2006. National Stage filed 
in AU, BR, CA, CN, EP, IL, IN, JP, MX, NZ, and US.
    PCT Application No. PCT/US2001/45624 filed 01 Nov 2001, which 
published as WO 2002/36806 on 10 May 2002 (HHS Reference No. E-308-
2000/0-PCT-02); claiming priority to 01 Nov 2000. National Stage filed 
in AU, CA, EP, JP, and US.
    U.S. Patent Application No. 11/571,879 filed 09 Jan 2007 (HHS 
Reference No. E-249-2004/1-US-02).
    Licensing Status: Available for licensing.

[[Page 14142]]

    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize HIV DNA vaccines. Please contact John D. Hewes, Ph.D. at 
301-435-3121 or [email protected] for more information.

     Dated: March 19, 2009.
 Richard U. Rodriguez,
 Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-6936 Filed 3-27-09; 8:45 am]
BILLING CODE 4140-01-P