[Federal Register Volume 76, Number 208 (Thursday, October 27, 2011)]
[Pages 66726-66727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27858]



National Institutes of Health

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.


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 Non-HLA-A2 Restricted Human T Cell Receptors (TCRs) That Could Be 
Used To Treat a Broader Cancer Patient Population Via TCR Adoptive 

    Description of Technology: NIH scientists have developed T cell 
receptors (TCRs) that recognize melanoma antigen family A3 (MAGE-A3) or 
MAGE-A12 peptide antigens. The TCRs recognize these antigens in the 
context of major histocompatibility complex (MHC) class I molecules, 
HLA-A1 and HLA-Cw7, respectively. Since these TCRs are not HLA-A2 
restricted, their therapeutic use would expand the number of treatable 
cancer patients using MAGE-A3 or A12-specific TCR adoptive 
    There are twelve MAGE-A superfamily antigens designated A1--A12. 
Their normal function is not well defined, but in cancer cells they 
block the functions of tumor suppressor proteins to mediate tumor 
growth and spreading. The MAGE-A proteins are some of the most widely 
expressed cancer testis antigens expressed on human tumors. Other than 
non-MHC expressing germ cells of the testis, normal cells do not 
express these antigens, which make them ideal targets for cancer 
immunotherapies anticipated to generate less toxic side effects than 
conventional cancer treatments. These TCRs deliver a robust immune 
response against MAGE-A3 or A12 expressing cells and could prove to be 
a powerful approach for selectively attacking tumors without generating 
toxicity against healthy cells.
    Potential Commercial Applications:
     Personalized immunotherapy for a variety of cancers using 
human T cells expressing these TCRs
     Component of a combination immunotherapy regimen aimed at 
targeting specific tumor-associated antigens, including MAGE-A3 and 
MAGE-A12, expressed by cancer cells.
     A research tool to investigate signaling pathways in MAGE-
A3 or MAGE-A12 antigen expressing cancer cells.
     An in vitro diagnostic tool to screen for cells expressing 
MAGE-A3 or MAGE-A12 antigens.
    Competitive Advantages:
     Highly expressed targets: MAGE-A proteins (especially 
MAGE-A3) are some of the most highly expressed cancer testis antigens 
on human tumors
     Limited side effects: MAGE-A proteins are only expressed 
on tumor cells and non-MHC expressing testis germ cells. Infused cells 
expressing these TCRs should target MAGE-A3 or A12 expressing tumor 
cells with little or no toxicity to the patient's normal cells.
     Not HLA-A2 restricted: Expands patient population 
treatable with MAGE-A TCRs since they recognize antigen in the context 
of HLA-A1 or HLA-Cw7.
    Development Stage:
     In vitro data available
    Inventors: Steven A. Rosenberg, Paul F. Robbins, Richard A. Morgan, 
Steven A. Feldman, and Shiqui Zhu (NCI).
    Publication: Chinnasamy N, et al. A TCR targeting the HLA-A*0201-
restricted epitope of MAGE-A3 recognizes multiple epitopes of the MAGE-
A antigen superfamily in several types of cancer. J Immunol. 2011 Jan 
15;186(2):685-696. [PMID 21149604].
    Intellectual Property: HHS Reference No. E-266-2011/0--U.S. Patent 
Application No. 61/535,086 filed 15 September 2011.
    Related Technology: HHS Reference No. E-236-2010/0--U.S.Patent 
Application No. 61/405,668 filed 22 October 2010.
    Licensing Contact: Samuel E. Bish, Ph.D.; (301) 435-5282; 
[email protected].
    Collaborative Research Opportunity: The Surgery Branch of the 
National Cancer Institute is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize T cell receptors that target cancer/
testis antigens for use in cancer adoptive immunotherapy. For 
collaboration opportunities, please contact John Hewes, Ph.D. at 
[email protected].

Antiandrogen Small Molecules for the Treatment of Prostate Cancer

    Description of Technology: The present licensing opportunity is for 
a new class of small molecule compounds, and the method of using them 
to treat prostate cancer. This year it is estimated there will be over 
32,000 deaths from prostate cancer showing an unmet need for a more 
effective treatment particularly for castrate-resistant prostate cancer 
(CRPC). CRPC is characterized by androgen-independent cancer cells that 
have adapted to the depletion of hormones and continue to grow. 
Abnormal androgen receptor signaling is known to drive advanced 
castrate-resistant prostate cancer. The small molecule compounds of the 
instant invention are antiandrogens that target androgen receptor 
signaling in both androgen-independent and androgen-sensitive androgen 
receptor activity, and androgen receptors that are resistant to the 
current antiandrogens available. Unlike the currently available

[[Page 66727]]

antiandrogens, the new small molecules induce androgen receptor 
degradation and cell death in prostate cancer cells. Further, these 
compounds and methods can also induce degradation of other steroid 
hormone receptors demonstrating the possibility of treating a wider 
range of cancers.
    Potential Commercial Applications:
     Series of steroid receptor compounds that cause cancer 
cell death
     Method of using the compounds in cancer treatment
    Competitive Advantages:
     First small molecule antiandrogen treatment
     Causes cell death, not just loss of function
     Potential to treat other cancers through degradation of 
other steroid hormone receptors
    Development Stage: In vitro data available.
    Inventors: Jane B. Trepel, Yeong Sang Kim, Sunmin Lee, Vineet 
Kumar, and Sanjay V. Malhotra (NCI).
    Intellectual Property: HHS Reference No. E-015-2011/0--U.S. Patent 
Application No. 61/497,129 filed 15 Jun 2011.
    Licensing Contact: Whitney Hastings; (301) 451-7337; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
Small Molecules for the Treatment of Prostate Cancer. For collaboration 
opportunities, please contact John Hewes, PhD at [email protected] or 
(301) 496-0477.

    Dated: October 21, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-27858 Filed 10-26-11; 8:45 am]