Government-Owned Inventions; Availability for Licensing, 1647-1648 [2014-00123]

Download as PDF PMANGRUM on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 6 / Thursday, January 9, 2014 / Notices US–01); PCT Patent Application No. PCT/US2006/040134, entitled ‘‘Rabies Virus Compositions and Methods’’, filed October 13, 2006, (E–326–2013/0–PCT– 02); and Chinese Patent Application No. 200680038314.4, entitled ‘‘Rabies Virus Compositions and Methods’’, filed October 13, 2006 (HHS Ref. No. E–326– 2013/0–CN–06). The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory is China, and the field of use may be limited to ‘‘Rabies vaccines based on the ERAg3m virus strain for veterinary use only.’’ DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before February 10, 2014 will be considered. ADDRESSES: Requests for copies of the patent application(s), inquiries, and comments relating to the contemplated exclusive license should be directed to: Whitney Blair, J.D., M.P.H., Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4937; Facsimile: (301) 402–0220; Email: whitney.blair@ nih.gov. SUPPLEMENTARY INFORMATION: This license specifically concerns a highly attenuated rabies virus, ERAg3m, with a mutation in the glycoprotein (G) gene and a switch of the G gene with the matrix protein gene in the viral genome. After a one-dose intramuscular vaccination, the ERAg3m virus protected 100% of mice and hamsters from lethal challenge. ERAg3m also may offer better protection than traditional inactivated vaccinations, as demonstrated in co-infection studies. This technology is capable of being developed into a one-dose rabies vaccine for human or veterinary use. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless within thirty (30) days from the date of the published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent VerDate Mar<15>2010 14:08 Jan 08, 2014 Jkt 232001 permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: January 2, 2014. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–00126 Filed 1–8–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. 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. 209 and 37 CFR part 404 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. FOR FURTHER INFORMATION CONTACT: 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. SUMMARY: New Compounds for Treating or Preventing Obesity Description of Technology: Available for licensing are new compounds developed for the treatment or prevention of obesity. The compounds act to block the absorption of dietary fats in the gut by interfering with signaling through the farnesoid X receptor. There is correlative evidence that inhibition of the farnesoid X receptor can reduce obesity resulting from high fat-based diets. While many farnesoid X receptor agonists are known, until now there have been no known therapeutic agents that can inhibit this receptor. Also available for licensing are methods of synthesizing the compounds PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 1647 and methods of using the compounds to treat or prevent obesity. Potential Commercial Applications: • Pharmaceutical treatments for obesity. • Pharmaceutical agents to reduce weight gain. Competitive Advantages: • There are no known therapeutic agents to inhibit the farnesoid X receptor; thus, agents developed from the present technology could be first-tomarket. • Compounds stay in the intestine and are not toxic. Development Stage: • Early-stage. • In vitro data available. • In vivo data available (animal). Inventors: Frank Gonzalez, Fei Li, Changtao Jiang, James Mitchell (all of NCI). Intellectual Property: HHS Reference No. E–508–2013/0—US Provisional Application No. 61/861,109 filed 01 August 2013. Licensing Contact: Patrick McCue, Ph.D.; 301–435–5560; mccuepat@ mail.nih.gov. Chimeric Antigen Receptors to CD276 (B7–H3) for Treatment of Cancer Description of Technology: Chimeric antigen receptors (CARs) are hybrid proteins consisting of an antibody binding fragment fused to protein signaling domains. When CARs are expressed in T-cells, the T-cells become cytotoxic towards cells expressing the proteins that the CAR recognizes. By developing a CAR that is specific for a cell surface protein that is selectively expressed on diseased cells, it is possible to selectively target those cells for destruction, thereby treating the disease. Solid tumors are typically treated with a non-specific approach of surgical resection, followed by chemotherapy or radiation therapy. Unfortunately, such an approach is traumatic for the patient, and leads to numerous side-effects. This suggests that a more specific approach to treating solid tumors is needed. CD276 (B7–H3) is a tumor-associated antigen that is expressed on several solid tumors, making it a promising therapeutic target. This technology concerns the generation of three highaffinity CARs (CD276.1, CD276.6 and CD276.17) that target CD276. These CARs can potentially be used in the treatment of cancers associated with CD276 expression. Potential Commercial Applications: • Treatment of diseases associated with increased or preferential expression of CD276. • Specific diseases include neuroblastoma, Ewing’s sarcoma, E:\FR\FM\09JAN1.SGM 09JAN1 1648 Federal Register / Vol. 79, No. 6 / Thursday, January 9, 2014 / Notices rhabdomyosarcoma, and prostate, ovarian, colorectal, and lung cancers. Competitive Advantages: • High affinity of the CARs increases the likelihood of successful targeting. • Targeted therapy decreases nonspecific killing of healthy, essential cells, resulting in fewer non-specific side-effects and healthier patients. Development Stage: • Early-stage. • In vitro data available. Inventors: Rimas J. Orentas, et al. (NCI). Intellectual Property: HHS Reference No. E–104–2013/0–US–01—US Provisional Patent Application No. 61/ 805,001 filed 25 March 2013. Related Technologies: • HHS Reference No. E–291–2012/ 0—International Patent Application No. PCT/US2013/060332 filed 18 September 2013; ‘‘M971 Chimeric Antigen Receptors,’’ Orentas R, et al. • HHS Reference No. E–007–2014/ 0—US Provisional Patent Application No. 61/865,845 filed 06 November 2013; ‘‘ALK Specific Chimeric Antigen Receptors,’’ Orentas R, Mackall C. Licensing Contact: David A. Lambertson, Ph.D.; 301–435–4632; lambertsond@mail.nih.gov. Collaborative Research Opportunity: The Pediatric Oncology Branch, CCR, NCI, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize chimeric antigen receptors (CARs) specific for tumor-expressed CD276 (B7–H3). For collaboration opportunities, please contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov. Competitive Advantages: • Immunotherapy targets latently infected cells harboring virus resistant to HAART. • Broadly neutralizing antibody fragment neutralizes extraneous viral particles. Development Stage: • Pre-clinical. • In vivo data available (animal). Inventors: Gary J. Nabel, Xiaoti Guo, Amarenda Pegu, Zhi-yong Yang (all of NIAID). Intellectual Property: • HHS Reference No. E–071–2012/ 0—US Application No. 61/638,437 filed 25 April 2012. • HHS Reference No. E–071–2012/ 1—PCT Application No. PCT/US2013/ 038214 filed 25 April 2013, which published as WO 2013/163427 on 31 October 2013. Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301–435–4507; ThalhamC@ mail.nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases, Vaccine Research Center, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize HIV–1 bispecific antibodies. For collaboration opportunities, please contact Barry Buchbinder, Ph.D. at 301–594–1696. Dated: January 2, 2014. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2014–00123 Filed 1–8–14; 8:45 am] PMANGRUM on DSK3VPTVN1PROD with NOTICES Bispecific Antibodies To Target Latent HIV–1 Infection BILLING CODE 4140–01–P Description of Technology: The invention describes bispecific antibodies designed to kill latently HIV– 1 infected T cells. It is thought that such bispecific antibodies will reduce or eliminate the pool of HIV–1 infected cells, contributing to functional cure. The antibody constructs comprise an HIV Env-binding fragment of a broadly neutralizing antibody linked to an antiCD3 single chain variable fragment (scFv). One embodiment is a VRC01 scFv linked to the anti-CD3 scFv . Other embodiments comprise Fab fragments of VRC07 or 10E8 antibodies linked to the anti-CD3 scFv. The bispecific antibody simultaneously stimulates infected cells to express gp120, instructs cytotoxic T cells to kill these cells, and neutralizes extraneous viral particles. Potential Commercial Applications: Immunotherapy of HAART-suppressed HIV–1 infection. DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Mar<15>2010 14:08 Jan 08, 2014 Jkt 232001 National Institutes of Health National Institute of Arthritis and Musculoskeletal and Skin Diseases: Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 The meeting 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 grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. Date: February 11, 2014. Open: 8:30 a.m. to 12:30 p.m. Agenda: Discussion of Program Policies. Place: National Institutes of Health, Building 31, Room 6, 31 Center Drive, Bethesda, MD 20892. Closed: 1:30 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, Room 6, 31 Center Drive, Bethesda, MD 20892. Contact Person: Laura K. Moen, Ph.D., Director, Division of Extramural Research Activities, NIAMS/NIH, 6700 Democracy Boulevard, Suite 800, Bethesda, MD 20892, 301–451–6515 moenl@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research, National Institutes of Health, HHS). Dated: January 2, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–00125 Filed 1–8–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\09JAN1.SGM 09JAN1

Agencies

[Federal Register Volume 79, Number 6 (Thursday, January 9, 2014)]
[Notices]
[Pages 1647-1648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00123]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, 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. 209 and 37 CFR part 404 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.

FOR FURTHER INFORMATION CONTACT: 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 Compounds for Treating or Preventing Obesity

    Description of Technology: Available for licensing are new 
compounds developed for the treatment or prevention of obesity. The 
compounds act to block the absorption of dietary fats in the gut by 
interfering with signaling through the farnesoid X receptor. There is 
correlative evidence that inhibition of the farnesoid X receptor can 
reduce obesity resulting from high fat-based diets. While many 
farnesoid X receptor agonists are known, until now there have been no 
known therapeutic agents that can inhibit this receptor.
    Also available for licensing are methods of synthesizing the 
compounds and methods of using the compounds to treat or prevent 
obesity.
    Potential Commercial Applications:
     Pharmaceutical treatments for obesity.
     Pharmaceutical agents to reduce weight gain.
    Competitive Advantages:
     There are no known therapeutic agents to inhibit the 
farnesoid X receptor; thus, agents developed from the present 
technology could be first-to-market.
     Compounds stay in the intestine and are not toxic.
    Development Stage:
     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Frank Gonzalez, Fei Li, Changtao Jiang, James Mitchell 
(all of NCI).
    Intellectual Property: HHS Reference No. E-508-2013/0--US 
Provisional Application No. 61/861,109 filed 01 August 2013.
    Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560; 
mccuepat@mail.nih.gov.

Chimeric Antigen Receptors to CD276 (B7-H3) for Treatment of Cancer

    Description of Technology: Chimeric antigen receptors (CARs) are 
hybrid proteins consisting of an antibody binding fragment fused to 
protein signaling domains. When CARs are expressed in T-cells, the T-
cells become cytotoxic towards cells expressing the proteins that the 
CAR recognizes. By developing a CAR that is specific for a cell surface 
protein that is selectively expressed on diseased cells, it is possible 
to selectively target those cells for destruction, thereby treating the 
disease.
    Solid tumors are typically treated with a non-specific approach of 
surgical resection, followed by chemotherapy or radiation therapy. 
Unfortunately, such an approach is traumatic for the patient, and leads 
to numerous side-effects. This suggests that a more specific approach 
to treating solid tumors is needed. CD276 (B7-H3) is a tumor-associated 
antigen that is expressed on several solid tumors, making it a 
promising therapeutic target. This technology concerns the generation 
of three high-affinity CARs (CD276.1, CD276.6 and CD276.17) that target 
CD276. These CARs can potentially be used in the treatment of cancers 
associated with CD276 expression.
    Potential Commercial Applications:
     Treatment of diseases associated with increased or 
preferential expression of CD276.
     Specific diseases include neuroblastoma, Ewing's sarcoma,

[[Page 1648]]

rhabdomyosarcoma, and prostate, ovarian, colorectal, and lung cancers.
    Competitive Advantages:
     High affinity of the CARs increases the likelihood of 
successful targeting.
     Targeted therapy decreases non-specific killing of 
healthy, essential cells, resulting in fewer non-specific side-effects 
and healthier patients.
    Development Stage:
     Early-stage.
     In vitro data available.
    Inventors: Rimas J. Orentas, et al. (NCI).
    Intellectual Property: HHS Reference No. E-104-2013/0-US-01--US 
Provisional Patent Application No. 61/805,001 filed 25 March 2013.
    Related Technologies:
     HHS Reference No. E-291-2012/0--International Patent 
Application No. PCT/US2013/060332 filed 18 September 2013; ``M971 
Chimeric Antigen Receptors,'' Orentas R, et al.
     HHS Reference No. E-007-2014/0--US Provisional Patent 
Application No. 61/865,845 filed 06 November 2013; ``ALK Specific 
Chimeric Antigen Receptors,'' Orentas R, Mackall C.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The Pediatric Oncology Branch, 
CCR, NCI, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize chimeric antigen receptors (CARs) specific for tumor-
expressed CD276 (B7-H3). For collaboration opportunities, please 
contact John D. Hewes, Ph.D. at hewesj@mail.nih.gov.

Bispecific Antibodies To Target Latent HIV-1 Infection

    Description of Technology: The invention describes bispecific 
antibodies designed to kill latently HIV-1 infected T cells. It is 
thought that such bispecific antibodies will reduce or eliminate the 
pool of HIV-1 infected cells, contributing to functional cure. The 
antibody constructs comprise an HIV Env-binding fragment of a broadly 
neutralizing antibody linked to an anti-CD3 single chain variable 
fragment (scFv). One embodiment is a VRC01 scFv linked to the anti-CD3 
scFv . Other embodiments comprise Fab fragments of VRC07 or 10E8 
antibodies linked to the anti-CD3 scFv. The bispecific antibody 
simultaneously stimulates infected cells to express gp120, instructs 
cytotoxic T cells to kill these cells, and neutralizes extraneous viral 
particles.
    Potential Commercial Applications: Immunotherapy of HAART-
suppressed HIV-1 infection.
    Competitive Advantages:
     Immunotherapy targets latently infected cells harboring 
virus resistant to HAART.
     Broadly neutralizing antibody fragment neutralizes 
extraneous viral particles.
    Development Stage:
     Pre-clinical.
     In vivo data available (animal).
    Inventors: Gary J. Nabel, Xiaoti Guo, Amarenda Pegu, Zhi-yong Yang 
(all of NIAID).
    Intellectual Property:
     HHS Reference No. E-071-2012/0--US Application No. 61/
638,437 filed 25 April 2012.
     HHS Reference No. E-071-2012/1--PCT Application No. PCT/
US2013/038214 filed 25 April 2013, which published as WO 2013/163427 on 
31 October 2013.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; ThalhamC@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Vaccine Research Center, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
HIV-1 bispecific antibodies. For collaboration opportunities, please 
contact Barry Buchbinder, Ph.D. at 301-594-1696.

    Dated: January 2, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-00123 Filed 1-8-14; 8:45 am]
BILLING CODE 4140-01-P
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