[Federal Register: August 21, 2007 (Volume 72, Number 161)]
[Notices]
[Page 46641-46642]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au07-81]
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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;
anos@mail.nih.gov.
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;
AnoS@mail.nih.gov
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;
joynesr@mail.nih.gov.
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 hewesj@mail.nih.gov 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;
soukasp@mail.nih.gov.
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