[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Notices]
[Pages 46641-46642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16400]


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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.

Prophylactic Vaccines and Therapeutic Monoclonal Antibodies Against 
Influenza

    Description of Technology: This technology describes development of 
H5N1 influenza vaccine candidates in which mutations have been 
introduced to increase affinity of the hemagglutinin (HA) for the 
sialic acid receptor found in humans, which have a different sialic 
acid linkage than the corresponding avian receptor. These mutations 
could therefore result in a higher immune response in vaccines, 
producing a more robust response than other H5N1 vaccine candidates 
that retain their avian receptor preferences. These mutations also 
changed antibody-sensitivity of the vaccine candidates. The H5 
modifications can be expressed from DNA or adenoviral vectors, or the 
proteins themselves can be administered. Additionally, these mutated 
HAs can be used to develop therapeutic monoclonal antibodies. The 
technology describes three (3) unique monoclonal antibodies that react 
with wild-type H5, wild-type H5 and mutant HA equivalently, and the 
mutant HA, respectively.
    Applications: Prophylactic influenza vaccine; Therapeutic 
antibodies.
    Inventors: Gary J. Nabel et al. (VRC/NIAID).
    Patent Status: U.S. Patent Application No. 60/850,761 filed 10 Oct 
2006 (HHS Reference No. E-306-2006/0-US-01).
    U.S. Patent Application No. 60/860,301 filed 20 Nov 2006 (HHS 
Reference No. E-306-2006/1-US-01).
    U.S. Patent Application No. 60/920,874 filed 30 Mar 2007 (HHS 
Reference No. E-306-2006/2-US-01).
    U.S. Patent Application No. 60/921,669 filed 02 Apr 2007 (HHS 
Reference No. E-306-2006/3-US-01).
    Development Status: Animal (mouse) data available.
    Licensing Status: Available for licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].

Antiviral Compounds With Broad Neutralization Capabilities

    Description of Technology: The NIH is pleased to announce as 
available for licensing a technology that provides for novel antiviral 
compounds effective against a broad spectrum of viruses. The compounds 
utilize soluble phospholipases, exemplified by PLA2-X and 
others, either alone or as a fusion protein with a viral binding 
polypeptide. These compositions are able to inactivate viruses through 
enzymatic degradation of the viral membrane without affecting target 
cells

[[Page 46642]]

of infection. The potential broad application of these compounds could 
address a significant health need for effective antivirals.
    Applications: This technology provides compositions and methods for 
the treatment of viral infection and has human and veterinary 
applications.
    Advantages: The compounds described by the current technology are 
not necessarily specific for a type of virus or viral strain like many 
currently available antiviral compounds, and therefore have broad 
therapeutic antiviral applications. Further, virions resistant to 
damage by antibody and complement have been shown to be lysed by 
compounds of the invention suggesting antiviral surveillance 
independent of a humoral immune response.
    Development Status: Proof of concept in vitro studies using human 
cells have shown antiviral activity with viruses pseudotyped with 
envelope proteins from Ebola, HIV, Marburg and MoMuLV.
    Inventors: Gary Nabel and Jae-Ouk Kim (VRC/NIAID).
    Publication: J-O Kim et al. Lysis of human immunodeficiency virus 
type 1 by a specific secreted human phospholipase A2. J 
Virol. 2007 Feb;81(3):1444-1450.
    Patent Status: PCT Application No. PCT/US2007/004471 filed 21 Feb 
2007 (HHS Reference No. E-013-2006/1-PCT-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected]

Design of Multi-Functional RNA Nanoparticles and Nanotubes

    Description of Invention: The characteristic function of 
nanoparticles is their ability to deliver drug across biological 
barriers to the target site while protecting the drugs from the 
biological environment until they reach the target site. The present 
invention provides polyvalent RNA nanostructures comprising RNA I 
inverse (RNA Ii) or RNA II inverse (RNA IIi) like motifs that have 
multiple positions available for conjugation of therapeutic, diagnostic 
or delivery agents. The nanoparticles of the invention do not induce 
significant immune response by themselves and are smaller than 
currently available nanoparticles and therefore allow for increased 
efficiency of administration. The nanoparticles of this invention have 
the ability to deliver one or more different therapeutic agents in a 
single particle. Further, the RNA nanoparticles are also capable of 
self-assembly into nanotubes of various shapes which offer potentially 
broad uses in medical implants, gene therapy, nanocircuits, scaffolds 
and medical testing.
    Applications:
    1. Use as diagnostic tool.
    2. Use as drug delivery composition to treat various diseases or 
conditions.
    3. Use in screening or identifying potential chemotherapeutic 
agents.
    4. Use in riboswitch aptamers, ribozymes or beacons.
    5. Use in nanocircuits, medical implants, gene therapy, scaffolds 
and medical testing.
    Market: Broad application in various fields, such as therapeutics, 
drug delivery, diagnostics, provides a wide market potential.
    Development Status: Early stage.
    Inventors: Bruce A. Shapiro and Yaroslava G. Yingling (NCI).
    Publication: YG Yingling and BA Shapiro. Computational Design of an 
RNA Hexagonal Nanoring and an RNA Nanotube. Nano Lett. 2007 Jul 6. Epub 
ahead of print,.doi 10.1021/nl070984r.
    Patent Status: U.S. Provisional Application No. 60/810,283 filed 02 
Jun 2006 (HHS Reference No. E-233-2006/0-US-01).
    U.S. Provisional Application No. 60/918,181 filed 14 Mar 2007 (HHS 
Reference No. E-233-2006/1-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Robert M. Joynes J.D., M.S.; 301/594-6565; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute's 
Nanobiology Program (http://www-lecb.ncifcrf.gov/bshapiro/index.html) 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate, or 
commercialize RNA nanostructures. Please contact John D. Hewes, Ph.D. 
at 301-435-3121 or [email protected] for more information.

Methods for Preparing Complex Multivalent Immunogenic Conjugates

    Description of Technology: Claimed in this application are novel 
methods for preparing complex multivalent immunogenic conjugates and 
conjugate vaccines. The multivalent conjugates and conjugate vaccines 
are synthesized by conjugating mixtures of more than one polysaccharide 
at a desired ratio of the component polysaccharides to at least one 
carrier protein using hydrazide chemistry. Because of the high 
efficiency of hydrazide chemistry in conjugation, the polysaccharides 
are effectively conjugated to the carrier protein(s) so that the 
resulting complex synthesized vaccine conjugate products, without 
requiring tedious and complicated purification procedures such as 
chromatography and/or ammonium sulfate precipitation, are efficacious 
in inducing antibodies in mice against each component polysaccharide. 
The methods claimed in this application simplify the preparation of 
multivalent conjugate vaccines by utilizing simultaneous conjugation 
reactions in a single reaction mixture or batch that includes at least 
two immunogenic-distinct polysaccharides. This single-batch 
simultaneous reaction eliminates the need for multiple parallel 
synthesis processes for each polysaccharide vaccine conjugate component 
as employed in conventional methods for making multivalent conjugate 
vaccines.
    Application: Cost effective and efficient manufacturing of 
conjugate vaccines.
    Inventors: Che-Hung Robert Lee (CBER/FDA).
    Patent Status: PCT Application No. PCT/US2007/006627 filed 16 Mar 
2007 (HHS Reference No. E-085-2005/0-PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing. The technology is not available for licensing in the field 
of use of multivalent meningitis vaccines.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].

    Dated: August 13, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-16400 Filed 8-20-07; 8:45 am]
BILLING CODE 4140-01-P