[Federal Register Volume 72, Number 72 (Monday, April 16, 2007)]
[Notices]
[Pages 19004-19006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7108]


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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.

New Mouse T Cell Receptors as Potential Therapeutic Agents for the 
Treatment of Metastatic Cancer

    Description of Technology: Adoptive immunotherapy is one of the 
most promising new therapeutic approaches to treat cancer.
    T cell receptors (TCR) are the proteins responsible for the T 
cell's ability to recognize infected or transformed cells. A TCR 
consists of two domains, one variable domain that recognizes the 
antigen and one constant region that helps the TCR anchor to the 
membrane and transmit the recognition signal by interacting with other 
proteins.
    This invention describes the identification of two mouse TCRs that 
target a common and highly expressed melanoma antigen, gp100, expressed 
by human cancers. These TCRs, have superior (100-1000 times) biological 
function compared to other human tumor-specific TCR that are currently 
in use in experimental trials using genetically engineered T cells. 
Therefore, these new TCRs represent potential therapeutic agents that 
can be used in the treatment of metastatic cancers, especially 
melanomas.
    Applications: New mouse TCRs have been identified that recognize 
human gp100; The mouse TCRs have 100-1000 times superior biological 
function compared to their human counterpart in recognizing gp100 when 
expressed in human lymphocytes; Human T cells genetically engineered to 
express new TCRs can serve as potential therapeutic agents in the 
treatment of patients with metastatic cancers; Clinical trials with 
these novel TCRs are currently being planned.
    Development Status: Pre-clinical work has been completed and 
clinical studies are forthcoming.
    Inventors: Nicholas P. Restifo et al. (NCI).
    Relevant Publications:
    1. A manuscript relating to this invention is under preparation and 
will be available once accepted.
    2. RA Morgan et al. Cancer regression in patients after transfer of 
genetically engineered lymphocytes. Science. 2006 Oct 6;314(5796):126-
129.
    Patent Status: U.S. Provisional Application No. 60/884,732 filed 12 
Jan 2007 (HHS Reference No. E-059-2007/0-US-01); U.S. Provisional 
Application No. 60/885,724 filed 19 Jan 2007 (HHS Reference No. E-059-
2007/1-US-01).
    Licensing Status: This technology is available for licensing under 
an exclusive or non-exclusive patent license.
    Licensing Contact: Michelle Booden, Ph.D.; 301/451-7337; 
[email protected].
    Collaborative Research Opportunity: The Surgery Branch, NCI, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this T cell receptor that is specific for human tumors. Please contact 
John D. Hewes, Ph.D. at 301-435-3121 or [email protected] for more 
information.

A Novel DNA Vaccine for the Treatment of Malignancies Expressing 
Immature Laminin Receptor Protein

    Description of Technology: This invention describes a new potent 
chemoattractant-based DNA vaccine to evoke therapeutic anti-tumor 
responses against tumors. The vaccine targets the antigen presenting 
cells (APCs) to efficiently present an antigen to MHC class I and class 
II molecules to induce tumor specific CD4 and CD8 T cell responses.
    The antigen tested is a highly conserved oncofetal antigen named 
immature laminin receptor protein (OFA-iLRP) that is preferentially 
expressed in malignant tissues. The vaccine construct consists of novel 
fusion proteins with enhanced binding affinities to augment antigen 
processing and antitumor responses.
    Applications and Modality:
    1. In vivo laboratory data shows that OFA-iLRP can be used as a 
potential immunotherapeutic antigen for the treatment of several 
malignancies including lymphoma, breast, lung, and ovarian.
    2. The vaccine construct is a novel fusion protein designed to 
enhance immunogenicity of OFA-iLRP via delivering it to chemokine 
receptors expressed on antigen presenting cells.
    3. The vaccine formulation will be most effective if used for 
treatment of cancer patients with minimal residual disease to protect 
from the disease relapse.
    4. The vaccine potentially could be effective as a preventive 
measure for people with cancer predisposition by eliciting long term 
anti-OFA-iLRP humoral and cellular memory.
    5. Very simple and less invasive vaccine that can be easily 
delivered to the skin, muscle or other tissues.

[[Page 19005]]

    Market: Previous attempts to produce a vaccine construct with OFA-
iLRP antigen have been laborious, expensive and non-reproducible 
showing no definitive demonstrations on the efficacy use of OFA-iLRP as 
a cancer vaccine. This simple chemoattractant based DNA vaccine is 
effective, potential cancer therapy with extensive in vivo data. It can 
be a valuable addition to the fast growing cancer vaccine market.
    Development Status: The technology is currently in the pre-clinical 
stage of development and planned for clinical tests in patients with 
NSCLC (tentative start date 2008).
    Inventors: Arya Biragyn et al. (NIA)
    Related Publications:
    1. A manuscript directly related to this technology will be 
available as soon as it is accepted for publication.
    2. A Biragyn et al. Genetic fusion of chemokines to a self tumor 
antigen induces protective, T-cell dependent antitumor immunity. Nat 
Biotechnol. 1999 Mar;17(3):253-258.
    3. A Biragyn et al. Mediators of innate immunity that target 
immature, but not mature, dendritic cells induce antitumor immunity 
when genetically fused with nonimmunogenic tumor antigens. J Immunol. 
2001 Dec 1;167(11):6644-6653.
    Patent Status: U.S. Provisional Application No. 60/841,927 filed 01 
Sep 2006, entitled ``Methods and Compositions for the Treatment and 
Prevention of Cancer'' (HHS Reference No. E-271-2006/0-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Thomas P. Clouse, J.D.; 301/435-4076; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging, Immunotherapeutics Unit, Laboratory of Immunology, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
simple and potent vaccines that target embryonic antigens expressed in 
tumors. Please contact John D. Hewes, Ph.D. at (301) 435-3121 or 
[email protected] for more information.

Preparation of (R,R)-Fenoterol and (R,R)-or (R,S)-Fenoterol Analogues 
and Their Use in Treating Congestive Heart Failure

    Description of Technology: This technology is directed to the 
discovery of (R,R)- and (R,S,)-fenoterol analogues which are highly 
effective and selective at binding [Beta]2-adrenergic receptors. The 
patent application includes methods of using such compounds and 
compositions for the treatment of cardiac disorders such as congestive 
heart failure and pulmonary disorders such as asthma or chronic 
obstructive pulmonary disease.
    Market: Approximately 5 million individuals are diagnosed with 
congestive heart failure in the United States and an estimated 3.5 
million hospitalizations are attributed to heart failure each year.
    Inventors: Irving W. Wainer et al. (NIA).
    Patent Status: U.S. Provisional Application No. 60/837,161 filed 10 
Aug 2006 (HHS Reference No. E-205-2006/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301/435-4521; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging, Laboratory of Clinical Investigation, is seeking statements of 
capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the use of 
fenoterol analogues in the treatment of cardiac disorders. Please 
contact John D. Hewes, Ph.D. at 301-435-3121 or [email protected] for 
more information.

Transgenic Mouse Model that has Defective Innate and Adaptive Immunity

    Description of Technology: The present research tool is a 
transgenic mouse model (C57BL/6 H-2b) that has defective 
innate and adaptive immunity. The mouse model harbors adaptive immunity 
cells, but lacks normal cellular responses and has an altered pattern 
of antibody production. The cells of the innate immune system (NK and 
NKT cells) are also nearly absent.
    The mouse model lacks lymph nodes. The mouse model also lacks the 
ability to reject autologous, allogeneic, and presumably xenogeneic 
cells. The mouse model also has a defective antibody production 
mechanism, making only early antibodies (IgM) and little, if any, 
mature isotypes (G2a, G2b).
    Applications and Modality:
    1. New mouse model to study human tumors.
    2. New mouse model to study immune function reconstitution.
    3. New mouse model to study the development of lymph nodes and role 
of lymph nodes in the disease process.
    4. Most mouse or human progenitor cells can be transferred to and 
engraft in the mouse model.
    Market:
    1. In 2006, 600,000 estimated deaths from cancer related diseases.
    2. Immunotherapy market is expected to double in the next 5 years.
    3. Research tool useful for adoptive immunotherapy studies.
    Development Status: The technology is a research tool.
    Inventor: John R. Ortaldo (NCI).
    Related Publications:
    1. JJ Subleski, VL Hall, TC Back, JR Ortaldo, RH Wiltrout. Enhanced 
antitumor response by divergent modulation of natural killer and 
natural killer T cells in the liver. Cancer Res. 2006 Nov 
15;66(22):11005-11012.
    2. JR Ortaldo, A Mason, J Willette-Brown, FW Ruscetti, J Wine, T 
Back, T Stull, EW Bere, L Feigenbaum, R Winkler-Pickett, and HA Young. 
Modulation of lymphocyte function with inhibitory CD2: Loss of NK and 
NKT function. Submitted to Blood (2/2007).
    Patent Status: HHS Reference No. E-290-2005/0--Research Tool. This 
technology is not patented. The mouse model will be transferred through 
a Material Transfer Agreement (for not-for-profit institutions) or 
through a Biological Materials License (commercial entities).
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact for Commercial Entities: Thomas P. Clouse; 301/
435-4076; [email protected].
    Material Transfer Agreement Contact for Not-For-Profit 
Institutions: Kathy Higinbotham; 301/846-5465; [email protected].

Dissection Tools and Methods of Use

    Description of Technology: Available for licensing is a dissection 
tool for cutting cell aggregates into smaller portions for further 
colony propagation. It is comprised of a handle attached to a rotatable 
shaft fitted with a cutting blade. The technology describes a safe and 
practical device that provides maximum product yield by preventing 
material from accumulating between the cutting surfaces. It also 
provides for more uniform cut colonies using lesser number of cuts than 
existing stem cell cutting instruments.
    Applications: Makes possible the sectioning of cultured embryonic 
stem cells into smaller fractions for their transfer to new culture 
medium and subsequent incubation.
    Market: Researchers worldwide who utilize cultured embryonic stem 
cells.
    Inventors: Soojung Shin (NIA).
    Patent Status: U.S. Provisional Application No. 11/531,972 filed 14 
Sep 2006 (HHS Reference No. E-272-2005/0-US-01).

[[Page 19006]]

    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Fatima Sayyid, M.H.P.M.; 301/435-4521; 
[email protected].

    Dated: April 9, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-7108 Filed 4-13-07; 8:45 am]
BILLING CODE 4140-01-P