Government-Owned Inventions; Availability for Licensing, 60276-60277 [E9-27925]

Download as PDF 60276 Federal Register / Vol. 74, No. 223 / Friday, November 20, 2009 / Notices brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 16, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–27956 Filed 11–19–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Applications • Generation of human, humanized, and chimeric nonhuman/human Fab antibody fragments. • Research tool to characterize Fab antibody fragments. National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. Advantages srobinson on DSKHWCL6B1PROD with NOTICES 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. Phage Display Plasmids With Improved Expression Properties for Human and Chimeric Nonhuman/Human Fab Libraries Description of Invention: The Fab molecule was the first generated antibody fragment and still dominates basic research and clinical applications. New phage display vectors were designed to generate and select Fab libraries with human constant domains. These vectors facilitate bacterial expression of human, humanized, and chimeric nonhuman/human Fab antibody fragments. They differ from currently available pComb3H and pComb3X phage display vectors by assembling human and chimeric nonhuman/human Fab libraries in two rather than three PCR steps. As a result, VerDate Nov<24>2008 17:03 Nov 19, 2009 Jkt 220001 these novel constructs retain the initial variable light and heavy chain sequences and improve the resulting Fab library’s complexity in terms of number, diversity, and affinity. These constructs were developed with and without a His tag and yield approximately 100 μg to 2 mg of protein, which can be used for evaluation and characterization of Fab binding properties such as affinity and specificity. Notably, the His tag provides a handle to easily purify Fab. pathogenesis of prostate cancers. These novel compounds are small molecules, and as such have an advantage over antibody-based technologies in this market. As prostate cancer is the most commonly diagnosed malignancy among men in the USA and Europe, the significant need for new therapies suggests that these novel LOX inhibitor compounds have a strong potential of reaching the marketplace. Applications • Therapeutics for prostate cancer. • Therapeutics for several other LOXassociated pathologies including atherosclerosis, asthma, other cancers, glomerulonephritis, osteoporosis, and Alzheimer’s disease. Advantages • Improved Fab library with complexity and number, diversity, and affinity. • His tag construct allows for simplified purification assays. Inventor: Christoph Rader (NCI). • Potent and selective inhibitory activity to reduce negative side effects. • Compounds are small molecules (less immunogenic than antibodies). Development Status: Pre-clinical. Inventors: David Maloney et al. (NHGRI). Relevant Publications Relevant Publications 1. KY Kwong and C Rader. E. coli expression and purification of Fab antibody fragments. Curr Protoc Protein Sci. 2009 Feb;Chapter 6:Unit 6.10. 2. T Hofer et al. Chimeric rabbit/ human Fab and IgG specific for members of the Nogo-66 receptor family selected for species cross-reactivity with an improved phage display vector. J Immunol Methods. 2007 Jan 10;318(1– 2):75–87. Patent Status: HHS Reference No. E– 008–2010/0—Research Tool. Patent protection is not being pursued for this technology. Licensing Status: Available for licensing. Licensing Contact: Jennifer Wong; 301–435–4633; wongje@mail.nih.gov. 1. V Kenyon et al. Novel human lipoxygenase inhibitors discovered using virtual screening with homology models. J Med Chem. 2006 Feb 23;49(4):1356–1363. 2. JD Deschamps et al. Baicalein is a potent in vitro inhibitor against both reticulocyte 15-human and platelet 12human lipoxygenases. Bioorg Med Chem. 2006 Jun 15;14(12):4295–4301. 3. Y Vasquez-Martinez et al. Structure-activity relationship studies of flavonoids as potent inhibitors of human platelet 12-hLO, reticulocyte 15hLO–1, and prostate epithelial 15-hLO– 2. Bioorg Med Chem. 2007 Dec 1;15(23):7408–7425. 4. J Inglese et al. Quantitative highthroughput screening: a titration-based approach that efficiently identifies biological activities in large chemical libraries. Proc Natl Acad Sci USA. 2006 Aug 1;103(31): 11473–11478. Patent Status: U.S. Provisional Application No. 61/238,972 filed 01 Sep 2009 (HHS Reference No. E–252–2009/ 0–US–01). Licensing Status: Available for licensing. Licensing Contact: Patrick P. McCue, Ph.D.; 301–435–5560; mccuepat@mail.nih.gov. Collaborative Research Opportunity: The NIH Chemical Genomics Center, NHGRI, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please Potent and Selective Inhibitors of Human Lipoxygenase for Prostate Cancer Therapy Description of Invention: With more than $2 billion in revenues in the US in 2007, the market for diagnostic and therapeutic products for prostate cancer is substantial. More than 2,000,000 American men currently live with prostate cancer and more than 200,000 new cases are diagnosed each year. Researchers led by Dr. David Maloney at the National Human Genome Research Institute (NHGRI) have discovered several novel compounds that selectively and potently inhibit lipoxygenase (LOX), an enzyme that metabolizes polyunsaturated fatty acids which has been implicated in the PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1 Federal Register / Vol. 74, No. 223 / Friday, November 20, 2009 / Notices contact Claire Driscoll at cdriscol@mail.nih.gov or 301–594–2235 for more information. Dated: November 13, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E9–27925 Filed 11–19–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0614] Guidance for Industry on Changes to Approved New Animal Drug Applications—New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability AGENCY: Food and Drug Administration, HHS. srobinson on DSKHWCL6B1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #191 entitled ‘‘Changes to Approved NADAs—New NADAs vs. Category II Supplemental NADAs.’’ This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA’s Center for Veterinary Medicine (CVM). DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for Veterinary Medicine (HFV–126), Food and Drug VerDate Nov<24>2008 17:03 Nov 19, 2009 Jkt 220001 Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8105, email: suzanne.sechen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry #191 entitled ‘‘Changes to Approved NADAs—New NADAs vs. Category II Supplemental NADAs.’’ This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The guidance explains how the Office of New Animal Drug Evaluation (ONADE) categorizes possible changes to approved new animal drugs that require reevaluation of safety and/or effectiveness data and explains which administrative vehicle—a new original new animal drug application (NADA) (new NADA) or a Category II supplemental application to the original new animal drug application (Category II supplemental NADA)—a sponsor should use when applying for approval of these changes. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by ONADE. In the Federal Register of December 16, 2008 (73 FR 76363), FDA published the notice of availability for a draft guidance entitled ‘‘Changes to Approved NADAs—New NADAs vs. Category II Supplemental NADAs,’’ which gave interested persons until February 17, 2009, to comment on the draft guidance. FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. In addition to some of the changes based on the comments received, CVM made a few minor changes to the guidance to add clarity and accuracy. The guidance announced in this notice finalizes the draft guidance dated December 16, 2008. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 60277 collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information have been approved under OMB control no. 0910–0032 (expiration date April 30, 2010). IV. Comments Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/AnimalVeterinary/ default.htm or https://www. regulations.gov. Dated: November 13, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–27926 Filed 11–19–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 74, Number 223 (Friday, November 20, 2009)]
[Notices]
[Pages 60276-60277]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27925]


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

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.

Phage Display Plasmids With Improved Expression Properties for Human 
and Chimeric Nonhuman/Human Fab Libraries

    Description of Invention: The Fab molecule was the first generated 
antibody fragment and still dominates basic research and clinical 
applications. New phage display vectors were designed to generate and 
select Fab libraries with human constant domains. These vectors 
facilitate bacterial expression of human, humanized, and chimeric 
nonhuman/human Fab antibody fragments. They differ from currently 
available pComb3H and pComb3X phage display vectors by assembling human 
and chimeric nonhuman/human Fab libraries in two rather than three PCR 
steps. As a result, these novel constructs retain the initial variable 
light and heavy chain sequences and improve the resulting Fab library's 
complexity in terms of number, diversity, and affinity. These 
constructs were developed with and without a His tag and yield 
approximately 100 [mu]g to 2 mg of protein, which can be used for 
evaluation and characterization of Fab binding properties such as 
affinity and specificity. Notably, the His tag provides a handle to 
easily purify Fab.

Applications

     Generation of human, humanized, and chimeric nonhuman/
human Fab antibody fragments.
     Research tool to characterize Fab antibody fragments.

Advantages

     Improved Fab library with complexity and number, 
diversity, and affinity.
     His tag construct allows for simplified purification 
assays.
    Inventor: Christoph Rader (NCI).

Relevant Publications

    1. KY Kwong and C Rader. E. coli expression and purification of Fab 
antibody fragments. Curr Protoc Protein Sci. 2009 Feb;Chapter 6:Unit 
6.10.
    2. T Hofer et al. Chimeric rabbit/human Fab and IgG specific for 
members of the Nogo-66 receptor family selected for species cross-
reactivity with an improved phage display vector. J Immunol Methods. 
2007 Jan 10;318(1-2):75-87.
    Patent Status: HHS Reference No. E-008-2010/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
wongje@mail.nih.gov.

Potent and Selective Inhibitors of Human Lipoxygenase for Prostate 
Cancer Therapy

    Description of Invention: With more than $2 billion in revenues in 
the US in 2007, the market for diagnostic and therapeutic products for 
prostate cancer is substantial. More than 2,000,000 American men 
currently live with prostate cancer and more than 200,000 new cases are 
diagnosed each year.
    Researchers led by Dr. David Maloney at the National Human Genome 
Research Institute (NHGRI) have discovered several novel compounds that 
selectively and potently inhibit lipoxygenase (LOX), an enzyme that 
metabolizes polyunsaturated fatty acids which has been implicated in 
the pathogenesis of prostate cancers. These novel compounds are small 
molecules, and as such have an advantage over antibody-based 
technologies in this market. As prostate cancer is the most commonly 
diagnosed malignancy among men in the USA and Europe, the significant 
need for new therapies suggests that these novel LOX inhibitor 
compounds have a strong potential of reaching the marketplace.

Applications

     Therapeutics for prostate cancer.
     Therapeutics for several other LOX-associated pathologies 
including atherosclerosis, asthma, other cancers, glomerulonephritis, 
osteoporosis, and Alzheimer's disease.

Advantages

     Potent and selective inhibitory activity to reduce 
negative side effects.
     Compounds are small molecules (less immunogenic than 
antibodies).
    Development Status: Pre-clinical.
    Inventors: David Maloney et al. (NHGRI).

Relevant Publications

    1. V Kenyon et al. Novel human lipoxygenase inhibitors discovered 
using virtual screening with homology models. J Med Chem. 2006 Feb 
23;49(4):1356-1363.
    2. JD Deschamps et al. Baicalein is a potent in vitro inhibitor 
against both reticulocyte 15-human and platelet 12-human lipoxygenases. 
Bioorg Med Chem. 2006 Jun 15;14(12):4295-4301.
    3. Y Vasquez-Martinez et al. Structure-activity relationship 
studies of flavonoids as potent inhibitors of human platelet 12-hLO, 
reticulocyte 15-hLO-1, and prostate epithelial 15-hLO-2. Bioorg Med 
Chem. 2007 Dec 1;15(23):7408-7425.
    4. J Inglese et al. Quantitative high-throughput screening: a 
titration-based approach that efficiently identifies biological 
activities in large chemical libraries. Proc Natl Acad Sci USA. 2006 
Aug 1;103(31): 11473-11478.
    Patent Status: U.S. Provisional Application No. 61/238,972 filed 01 
Sep 2009 (HHS Reference No. E-252-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560; 
mccuepat@mail.nih.gov.
    Collaborative Research Opportunity: The NIH Chemical Genomics 
Center, NHGRI, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize this technology. Please

[[Page 60277]]

contact Claire Driscoll at cdriscol@mail.nih.gov or 301-594-2235 for 
more information.

    Dated: November 13, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-27925 Filed 11-19-09; 8:45 am]
BILLING CODE 4140-01-P

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