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


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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, 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. 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; 
[email protected].

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; 
[email protected].
    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 [email protected].

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; [email protected].
    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