Government-Owned Inventions; Availability for Licensing, 66726-66727 [2011-27858]

Download as PDF 66726 Federal Register / Vol. 76, No. 208 / Thursday, October 27, 2011 / Notices OIRA_submission@omb.eop.gov, or by fax to 202–395–6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Jamelle E. Banks, Public Health Analyst, Office of Science Policy, Analysis and Communication, National Institute of Child Health and Human Development, 31 Center Drive Room 2A18, Bethesda, Maryland, 20892, or call a non-toll free number (301) 496–1877 or E-mail your request, including your address to banksj@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: October 20, 2011. Jamelle E. Banks, Public Health Analyst, Office of Science Policy, Analysis and Communications, National Institute of Child Health and Human Development, National Institutes of Health. [FR Doc. 2011–27843 Filed 10–26–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. AGENCY: ACTION: Notice. 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. SUMMARY: 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. wreier-aviles on DSK7SPTVN1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 14:47 Oct 26, 2011 Jkt 226001 New Non-HLA–A2 Restricted Human T Cell Receptors (TCRs) That Could Be Used To Treat a Broader Cancer Patient Population Via TCR Adoptive Immunity 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 immunotherapy. 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. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 • 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: • Pre-clinical • 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*0201restricted 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; bishse@mail.nih.gov. 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 hewesj@mail.nih.gov. 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 castrateresistant prostate cancer (CRPC). CRPC is characterized by androgenindependent 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 androgenindependent and androgen-sensitive androgen receptor activity, and androgen receptors that are resistant to the current antiandrogens available. Unlike the currently available E:\FR\FM\27OCN1.SGM 27OCN1 Federal Register / Vol. 76, No. 208 / Thursday, October 27, 2011 / Notices 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; hastingw@mail.nih.gov. 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 hewesj@mail.nih.gov 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] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. wreier-aviles on DSK7SPTVN1PROD with NOTICES AGENCY: 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 SUMMARY: VerDate Mar<15>2010 14:47 Oct 26, 2011 Jkt 226001 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. Protease Deficient Bacillus anthracis With Improved Recombinant Protein Yield Capabilities Description of Technology: Species of Bacillus, such as Bacillus anthracis, Bacillus cereus, and Bacillus subtilis, are attractive microorganisms for recombinant protein production in view of their fast growth rate, high yield, and ability to secrete produced products directly into the medium. Bacillus anthracis is also attractive in view of its ability to produce anthrax toxin and ability to fold proteins correctly. This application claims a B. anthracis strain in which more than one secreted protease is inactivated by genetic modification. Such a protease-deficient B. anthracis has an improved ability to produce recombinant secreted proteins compared to other bacteria, particularly other Bacillus. Improvements include production of intact (i.e., mature fulllength) proteins, often at high yield. Potential Commercial Applications: • Vaccine production • Recombinant protein production • B. anthracis vaccine production Competitive Advantages: • Highly efficient production of recombinant proteins • Low cost production of recombinant proteins Development Stage: • Early-stage • In vitro data available Inventors: Andrei Pomerantsev and Stephen Leppla (NIAID). Publication: Pomerantsev A, et al. A Bacillus anthracis strain deleted for six proteases serves as an effective host for production of recombinant proteins. Protein Expr Purif. 2011 Nov;80(1):80– 90. [PMID 21827967]. Intellectual Property: • HHS Reference No. E–202–2011/0 —U.S. Provisional Application No. 61/ 514,384 filed 02 Aug 2011 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 66727 • HHS Reference No. E–202–2011/1 —U.S. Provisional Application No. 61/ 521,617 filed 09 Aug 2011 Licensing Contact: Peter Soukas, J.D.; (301) 435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The NIAID is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize B. anthracis vaccines, B. anthracis protein production. For collaboration opportunities, please contact Charles Rainwater at (301) 435– 8617. Parvovirus B19 Codon Optimized Structural Proteins for Vaccine and Diagnostic Applications Description of Technology: Parvovirus B19 (B19V) is the only known pathogenic human parvovirus. Infection by this viral pathogen can cause transient aplastic crisis in individuals with high red cell turnover, pure red cell aplasia in immunosuppressed patients, and hydrops fetalis during pregnancy. In children, B19V most commonly causes erythema infectiosum, or fifth’s disease. Infection can also cause arthropathy and arthralgia. The virus is very erythrotropic, targeting human erythroid (red blood) progenitors found in the blood, bone marrow, and fetal liver. Currently, there are no approved vaccines or antiviral drugs for the treatment or prevention of B19V infection. The subject technology is a series of plasmid constructs with codon optimized B19 viral capsid genes (VP1 and VP2) that can be expressed in mammalian cells. Transfection of vectors encoding these optimized VP1 and VP2 genes into different mammalian cell lines, including 293, Cos7, and HeLa cells produce virus-like particles (VLPs). The vectors include bicistronic plasmids expressing the VP1 and VP2 proteins at different ratios to produce B19V VLPs with optimal antigenicity for vaccine applications. This technology can also be used for diagnostic applications and development of a viral packaging system for producing infectious B19V virus. Applications: • VLPs based vaccines for the prevention and/or treatment of B19V infection • DNA based vaccines for the prevention and/or treatment of B19V infection • B19V diagnostics • Viral packaging system Advantages: E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
Immunity

    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 
immunotherapy.
    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:
     Pre-clinical
     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; 
bishse@mail.nih.gov.
    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 
hewesj@mail.nih.gov.

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; 
hastingw@mail.nih.gov.
    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 hewesj@mail.nih.gov 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]
BILLING CODE 4140-01-P

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