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[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Notices]
[Pages 50215-50216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23590]

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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.

Immortalized Transformed Lymphoblastoid Cell Lines From Patients with 
Fran[ccedil]ois-Neetens Mouchet[eacute]e Fleck Corneal Dystrophy (CFD)

    Description of Invention: Researchers at the National Eye 
Institute, NIH, have made available a set of immortalized transformed 
lymphoblastoid cell lines created from human T-lymphocytes obtained 
from patients with Fran[ccedil]ois-Neetens Mouchet[eacute]e Fleck 
Corneal Dystrophy (CFD). The cells were transformed with defective 
Epstein-Barr virus using established methods.
    CFD is a rare, autosomal dominant corneal dystrophy characterized 
by numerous small white flecks scattered in all layers of the stroma. 
CFD has been associated with mutations in the PIP5K3 protein, which is 
important for post-Golgi vesicle processing.
    Applications:
     Useful in the study of proteins expressed by lymphocytes, 
including in some cases the protein encoded by the mutant gene KCNJ13.
     Useful as a renewable source of DNA for genetic studies 
related to CFD or the PIP5K3 protein.
    Inventors: J. Fielding Hejtmancik and Xiaodong Jiao (NEI).
    Relevant Publications:
    1. S Li et al. Mutations in PIP5K3 are associated with 
Fran[ccedil]ois-Neetens mouchet[eacute]e fleck corneal dystrophy. Am J 
Hum Genet. 2005 Jul;77(1):54-63.
    2. X Jiao et al. Genetic linkage of Francois-Neetens fleck 
(mouchet[eacute]e) corneal dystrophy to chromosome 2q35. Hum Genet. 
2003 May; 112(5-6):593-599.
    Patent Status: HHS Reference No. E-270-2009/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing under a biological 
material license.
    Licensing Contact: Patrick P. McCue, PhD; 301-435-5560; 
[email protected].

Novel Chemoattractant-Based Toxins to Improve Vaccine Immune Responses 
for Cancer and Infectious Diseases

    Description of Invention: Cancer is one of the leading causes of 
death in United States and it is estimated that there will be more than 
half a million deaths caused by cancer in 2009. A major drawback of the 
current chemotherapy-based therapeutics is the cytotoxic side-effects 
associated with them. Thus there is a dire need to develop new 
therapeutic strategies with fewer side-effects. Immunotherapy has taken 
a lead among the new therapeutic approaches. Enhancing the innate 
immune response of an individual has been a key approach for the 
treatment against different diseases such as cancer and infectious 
diseases.

[[Page 50216]]

    This technology involves the generation of novel chemoattractant 
toxins that deplete the T regulatory cells (Treg) or other 
immunosuppressive or hyperactivated cells locally. Treg controls 
activation of immune responses by suppressing the induction of adaptive 
immune responses, particularly T cell responses. Immunosuppressive 
cells such as tumor infiltrating macrophages, regulatory T cells, 
regulatory B cells, or NKT and other cells down regulate antitumor 
immune responses. The chemoattractant toxins consist of a toxin moiety 
fused with a chemokine receptor ligand, such as chemokines and various 
chemoattractants, that enables specific targeting and delivery to the 
regulatory cells. This technology is advantageous over the more harmful 
antibodies and chemicals that are currently used for the systemic 
depletion of regulatory cells. The current technology can be used 
therapeutically in a variety of ways. They can be used together with 
vaccines to increase efficacy of the vaccine for the treatment of 
cancer, and can be used to locally deplete Treg, Bregs, or other 
immunosuppressive cells to induce cytolytic cell responses at the tumor 
site or to eliminate chronic infectious diseases such as HIV and 
tuberculosis.
    Applications:
     New chemoattractant based toxins targeted towards Treg 
cells.
     New chemoattractant based toxins targeted towards 
immunosuppressive B cells, NKT and macrophages.
     New chemoattractant based toxins targeted towards local 
depletion of hyperactivated CD4 T cells to treat autoimmune diseases.
     Chemoattractant based toxins depleting Treg cells or other 
immunosuppressive cells causing enhanced vaccine immune responses.
     Novel immunotherapy by increasing vaccine efficacy against 
cancer and infectious diseases.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market:
     The technology platform involving novel chemo-attractant 
based toxins can be used to improve vaccine immune responses.
     The technology platform has an additional market in 
treating several other clinical problems such as autoimmune diseases.
    Inventors: Arya Biragyn (NIA), Dolgor Bataar (NIA), et al.
    Related Publications:
    1. D Baatar, P Olkhanud, D Newton, K Sumitomo, A Biragyn. CCR4-
expressing T cell tumors can be specifically controlled via delivery of 
toxins to chemokine receptors. J Immunol. 2007 Aug 1;179(3):1996-2004.
    2. D Baatar, P Olkhanud, K Sumitomo, D Taub, R Gress, A Biragyn. 
Human peripheral blood T regulatory cells (Tregs), functionally primed 
CCR4+ Tregs and unprimed CCR4- Tregs, regulate effector T cells using 
FasL. J Immunol. 2007 Apr 15;178(8):4891-900.
    3. M Coscia, A Biragyn. Cancer immunotherapy with chemoattractant 
peptides. Semin Cancer Biol. 2004 Jun; 14(3):209-218.
    4. R Schiavo et al. Chemokine receptor targeting efficiently 
directs antigens to MHC class I pathways and elicits antigen-specific 
CD8+ T-cell responses. Blood 2006 Jun 15; 107(12):4597-4605.
    Patent Status: U.S. Patent Application No. 11/992,880 filed 28 Mar 
2008 (HHS Reference No. E-027-2005/0-US-06)
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, PhD; 301-435-5560; 
[email protected].
    Collaborative Research Opportunity: The Immunotherapeutics Unit, 
National Institute on Aging, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize Chemotoxin technology for clinical 
use or as a laboratory tool for depletion of cells. Please contact 
Nicole Darack, PhD at 301-435-3101 or [email protected] for more 
information.

Novel Agents Exhibiting Cytotoxicity Against Human Tumor Cell Lines

    Description of Invention: Researchers at the National Cancer 
Institute have developed novel agents that inhibit the growth of 
several human tumor cell lines. The new compounds are phenyl 
maleimides, some of which show cytotoxicity against human liver cancer 
cells in vitro in the low micromolar range.
    Applications:
     Therapeutics for treating a broad range of cancers.
     Use as pharmacologic probes for specific biochemical 
pathways.
    Advantages:
     Demonstrated selective inhibition for cancer cells vs. 
untransformed cells in vitro and in vivo.
     Potent growth inhibition of several human tumor cell 
lines.
    Development Status: Pre-clinical stage of development.
    Market: Cancer therapeutics.
    Inventors: Christophr J. Michejda and Wei Yao (NCI) et al.; 
Terrence R. Burke Jr. (NCI).
    Relevant Publication: S Kar, M Wang, W Yao, CJ Michejda, BI Carr. 
PM-20, a novel inhibitor of Cdc25A, induces extracellular signal-
regulated kinase 1/2 phosphorylation and inhibits hepatocellular 
carcinoma growth in vitro and in vivo. Mol Cancer Ther. 2006 Jun; 
5(6):1511-1519.
    Patent Status: U.S. Patent No. 7,504,430 issued 17 Mar 2009 (HHS 
Reference No. E-110-2004/0-US-06).
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, PhD; 301-435-5560; 
[email protected].

    Dated: September 21, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-23590 Filed 9-29-09; 8:45 am]
BILLING CODE 4140-01-P
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