[Federal Register Volume 72, Number 210 (Wednesday, October 31, 2007)]
[Notices]
[Pages 61658-61660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21370]


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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.

Immunostimulatory Combinations of TLR Ligands and Methods of Use

    Description of Technology: New drugs or therapies that act by 
stimulating the immune system, or alternatively inhibiting certain 
aspects of the immune system, may be useful for treating various 
diseases or disorders, for example viral diseases, neoplasias, and/or 
allergies, and may also have use as vaccine adjuvants. However, 
although adjuvants have been suggested for use in vaccine compositions, 
there is an unmet need for adjuvants that can effectively enhance 
immune response.
    Development of innate and adaptive immunity critically depends on 
the engagement of pattern recognition receptors (PRRs), which 
specifically detect microbial components named pathogen- or microbe-
associated molecular patterns (PAMPs or MAMPs) (1-4). Toll-like 
receptors (TLRs) represent an important group of PRRs that can sense 
PAMPs or MAMPs once in the body. TLRs are widely expressed by many 
types of cells, for example cells in the blood, spleen, lung, muscle 
and intestines.
    The present invention claims immunostimulatory combinations of TLR 
ligands and therapeutic and/or prophylactic methods that include 
administering an immunostimulatory combination to a subject. In 
general, the immunostimulatory combinations can provide an increased 
immune response compared to other immunostimulatory combinations and/or 
compositions. More specifically, combinations of TLR 2, 3 and 9 are 
claimed. The application also describes a novel mechanism for TLR 
synergy in terms of both signaling pathways and cytokine combinations.
    Application: Development of improved adjuvants and/or synergistic 
combinations of adjuvants for vaccines.
    Developmental Status: Compositions have been synthesized and 
preclinical studies have been performed.
    Inventors: Jay Berzofsky and Qing Zhu (NCI).
    Patent Status: U.S. Provisional Application filed 24 Sep 2007 (HHS 
Reference No. E-298-2007/0-US-01).
    Licensing Status: Available for exclusive or nonexclusive 
licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute's 
Vaccine Branch is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this invention of synergistic combinations 
of TLR ligands. Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

[[Page 61659]]

Cellular Receptor for Varicella-Zoster Virus, Methods of Inhibiting 
Spread of Varicella-Zoster and Methods of Increasing Stability and 
Infectivity of the Virus

    Description of Technology: This technology relates to 
identification of insulin degrading enzyme (IDE) as a cellular receptor 
for Varicella-Zoster-Virus (VZV), the etiologic agent of varicella 
(chickenpox) and zoster (shingles). Acute infection of VZV is followed 
by cell-associated viremia and the development of varicella rash. The 
virus establishes life-long latency in the nervous system and can 
reactivate to cause zoster. The mechanism of VZV entry into target 
cells and spread from cell-to-cell is not well understood. The 
inventors have shown that antibodies to IDE and soluble IDE partially 
inhibit infection with the virus in cell culture. Reducing the level of 
IDE in the cell (with siRNA), or blocking the ability of IDE to bind 
with a VZV glycoprotein, markedly diminishes cell-to-cell spread of the 
virus in cell culture and partially inhibits infection of cells with 
cell-free virus. This invention further describes molecules that may 
have a role in the treatment or prevention of VZV infections, including 
antibodies to IDE, peptides that block IDE-VZV interactions, and other 
molecules that block binding activity of IDE.
    Applications: Treatment and prevention of varicella zoster virus 
infection.
    Market: Prophylactics and therapeutics for chickenpox and shingles.
    Development Status: Early-stage technology.
    Inventors: Jeffery Cohen and Qingxue Li (NIAID).
    Patent Status: U.S. Provisional Application No. 60/684,526 filed 26 
May 2005 (HHS Reference No. E-289-2004/0-US-01); PCT Application No. 
PCT/US2006/020514 filed 26 May 2006 (HHS Reference No. E-289-2004/0-
PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Chekesha S. Clingman, PhD; 301/435-5018; 
[email protected].
    Collaborative Research Opportunity: The NIAID Laboratory of 
Infectious Diseases, Medical Virology Section, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact Dr. Jeffrey Cohen at [email protected] 
for more information.

An HIV Protein for Use as a Novel Therapeutic or Vaccine Component

    Description of Technology: Latent HIV presents a challenge for 
complete removal of the virus in infected individuals and is becoming 
an increasingly important consideration in the identification of 
potential HIV therapeutics or treatment regimens. These 
transcriptionally inactive HIV reservoirs lay dormant in a portion of 
infected cells and are capable of evading both host defenses and 
existing antiretroviral therapy. The present technology offers a 
potential solution for complete eradication of HIV in infected 
individuals.
    This technology describes immunogenic and therapeutic compositions 
related to HIV p28TEV protein, the first protein expressed during HIV 
infection in the case of the pHXB2 isolate. p28TEV functions in the 
regulation of HIV transcription and may be important for the expression 
of latent virus. A number of p28TEV associated compositions are 
available for licensing and commercial development including: (1) The 
p28TEV polypeptide from one or more HIV clades, (2) nucleic acids 
encoding these p28TEV polypeptides, (3) a polypeptide with significant 
sequence homology to p28TEV, and (4) immunogenic fragments of these 
polypeptides. Additional compositions include antibodies and 
antagonists that act to inhibit p28TEV activity. Adjuvants, 
immunomodulators and compounds used in combination with p28 TEV for the 
treatment of HIV infection are also included in the available 
technology.
    Applications: Novel therapeutics for treatment of HIV infection; 
Novel HIV vaccine component.
    Development Status: Preclinical data are available at this time.
    Inventors: Genoveffa Franchini et al. (NCI).
    Patent Status: U.S. Patent Application No. 11/364,873 filed 27 Feb 
2006 (HHS Reference No. E-072-2004/3-US-01); PCT Application No. PCT/
US2007/0004694 filed 23 Feb 2007, which published as WO 2007/098257 on 
30 Aug 2007 (HHS Reference No. E-072-2004/4-PCT-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Susan Ano, PhD; 301/435-5515; [email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Vaccine Branch is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize Methods of Targeting the Establishment of 
the HIV Viral Reservoir. Please contact John D. Hewes, PhD at 301-435-
3121 or [email protected] for more information.

Methods for Identifying Cathepsin G-Related Peptides as Modulators of 
Formylpeptide Receptors

    Description of Technology: Available for licensing and commercial 
development are methods for identifying peptides of Cathepsin G (CaG), 
or active variants thereof, which modulate activities of the receptor 
for bacterial chemotactic formyl peptides (FPR), including chemotactic 
behavior. It provides methods of designing therapeutic approaches 
related to the host defense based on the interaction of CaG and FPR, as 
CaG binds to FPR to mediate the proinflammatory activities of CaG. The 
inventive aspects relate to the finding that CaG induces a more partial 
and selective effects upon activation of FPR to mediate a certain and 
more limited immunological activity than other agonists that are also 
capable of binding FPR. The limitations in the activity include not 
inducing calcium flux, having only a weak activation of mitogen-
activated protein kinases (MAPKs), and being able to activate certain 
types of atypical protein kinase C (PKC), such as PKC[xgr], while not 
activating PKC[alpha] and PKC[beta]. These limitations are advantageous 
in attempting to limit the response in mobilizing the phagocytic 
leukocyte infiltration to mediate the clearance and repair of damaged 
tissue while not amplifying the general inflammatory response, which 
may result in damage to healthy and normal tissue.
    Applications: Identification of peptides of Cathepsin G that 
activate certain types of atypical protein kinase C, such as PKC[xgr], 
while not activating PKC[alpha] and PKC[beta], to limit the response in 
mobilizing the phagocytic leukocyte infiltration while not amplifying 
the general inflammatory response.
    Inventors: Ji Ming Wang, Ronghua Sun, Joost Oppenheim, Ye Zhou 
(NCI).
    Relevant Publication: R Sun et al. Identification of neutrophil 
granule protein cathepsin G as a novel chemotactic agonist for the G 
protein-coupled formyl peptide receptor. J Immunol. 2004 Jul 
1;173(1):428-436.
    Patent Status: U.S. Patent Application No. 11/154,744 filed 17 Jun 
2005, entitled ``Cathepsin G-Related Peptides as Modulators of 
Formylpeptide Receptors (FPR),'' published as U.S. 20060008891 (HHS 
Reference No. E-281-2003/2-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.

[[Page 61660]]

    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301/
435-4507; [email protected].

    Dated: October 24, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-21370 Filed 10-30-07; 8:45 am]
BILLING CODE 4140-01-P