[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5818-5819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01620]


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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, Public Health Service, 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. 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.

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.

SIRT2 Inhibitors as Novel Therapeutics for Myocardial Infarction and 
Ischemic Stroke and to Prevent Necrosis

    Description of Technology: Sirtuin 2 (SIRT2) inhibitors to reduce 
necrosis and, thereby, as novel therapeutics to treat ischemic stroke 
and myocardial infarction. Accumulating evidence indicates that 
programmed necrosis plays a critical role in cell death during 
ischemia-reperfusion. NIH investigators have shown that the NAD-
dependent deacetylase SIRT2 binds constitutively to receptor-
interacting protein 3 (RIP3) and that deletion or knockdown of SIRT2 
prevents formation of the RIP1-RIP3 complex in mice. These 
investigators also found that genetic or pharmacological inhibition of 
SIRT2 blocks cellular necrosis induced by TNF-alpha and RIP1 is a 
critical target of SIRT2-dependent deacetylation. Further studies also 
showed that the hearts of Sirt2	/	 mice, or wild-type mice treated with 
a specific pharmacological inhibitor of SIRT2, show marked protection 
from ischemic injury. These results implicate SIRT2 as an important 
regulator of programmed necrosis and indicate that SIRT2 inhibitors may 
constitute a novel approach to protect against necrotic injuries, 
including ischemic stroke and myocardial infarction.
    Potential Commercial Applications:
     Novel therapeutics to protect against necrotic injuries.
     Novel therapeutics to treat ischemic stroke and myocardial 
infarction.
     Novel therapeutics to treat diseases in which necrosis is 
involved.
    Competitive Advantages:
     None of the currently available drugs address the necrotic 
damage caused due to ischemia and reperfusion.
     Using a SIRT2 inhibitor could limit the damage caused by 
necrosis and contribute to accelerated recovery in patients suffering 
from these conditions.
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Drs. Nisha Narayan and Toren Finkel (NHLBI)
    Publication: Narayan N, et al. The NAD-dependent deacetylase SIRT2 
is required for programmed necrosis. Nature. 2012 Dec 13;492(7428):199-
204. [PMID 23201684]
    Intellectual Property: HHS Reference No. E-003-2013/0--U.S. 
Application No. 61/723,496 filed 17 Nov 2012
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov
    Collaborative Research Opportunity: The NHLBI is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate or commercialize retinoid-related 
orphan receptors (RORs) function in chronic diseases. For collaboration 
opportunities, please contact Ms. Peg Koelble at koelblep@mail.nih.gov 
or 301-594-4095.

Multivalent Meningiococcal Conjugates and Methods for Preparing 
Conjugates

    Description of Technology: Among 13 isolated meningococcal 
serogroups, A, B, C, W-135 and Y are the most prevalent. There are 
three FDA-approved capsular polysaccharide (PS)-based vaccines, one 
tetravalent PS vaccine, and two tetravalent conjugate vaccines for 
protection against

[[Page 5819]]

meningococcal disease caused by groups A, C, W-135 and Y Neisseria 
meningitidis. Group B capsular PS is similar to the PS structure 
expressed in certain human tissues, thus making it a poor immunogen. 
Furthermore, if used as a vaccine, the possibility exists of it 
inducing an autoimmune response. Thus, a need remains to develop 
additional meningococcal vaccines, particularly for group B and group X 
meningococcal serogroups.
    This application claims immunogenic conjugates including at least 
one polysaccharide conjugated to a group B factor H binding protein 
(fHbp). Also claimed are immunogenic conjugates including at least one 
polysaccharide conjugated to a Neisserial surface protein A (NspA). 
Additionally, improved methods for preparing conjugates are claimed.
    Potential Commercial Applications:
     Multivalent meningitis vaccine
     Research tool
    Competitive Advantages:
     Higher vaccine yield
     More efficient conjugation method
     Lower cost vaccines
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Che-Hung Robert Lee (FDA/CBER), Vavlerian Pinto (EM), 
Elizabeth Moran (EM), Robert Burden (EM)
    Intellectual Property: HHS Reference No. E-082-2012/0--U.S. 
Application No. 61/651,382 filed 24 May 2012.
    Related Technologies:
     HHS Reference No. E-301-2003/0--U.S. Application No. 13/
243,480 filed 06 Aug 2004, claiming priority to 06 Aug 2003
     HHS Reference No. E-085-2005/0--U.S. Patent 8,173,135 
issued 08 May 2012; U.S. Application No. 13/440,856 filed 05 Apr 2012, 
claiming priority to 17 Mar 2006
    Licensing Contact: Peter A. Soukas; 301-435-4646; ps193c@nih.gov
    Collaborative Research Opportunity: The FDA/CBER is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
Multivalent Meningiococcal Conjugates and Methods for Preparing 
Conjugates. For collaboration opportunities, please contact Che-Hung 
Robert Lee at robert.lee@fda.hhs.gov or 301-451-5934.

Enhanced Cancer Therapy Using Photoimmunotherapy (PIT) in Combination 
With Anti-Cancer Agents

    Description of Technology: The invention is in the field of 
Photoimmunotherapy (PIT). More specifically, the invention relates to 
antibody-fluorophore conjugates where the antibody is specific for 
cancer cells and the fluorophore is IR700 dye. Binding of such 
conjugates to targeted cancer cells followed by irradiation with near 
infrared light (NIR) was shown to kill cancer cells in a highly 
specific manner. Furthermore, the invention discloses that the 
therapeutic effect of the PIT conjugate is significantly enhanced by 
the administration of one or more anti-cancer agents following the 
irradiation step. This is achieved by the markedly rapid accumulation 
of the therapeutic agent in the PIT-treated tissue. Also provided in 
the invention are wearable devices that incorporate NIR light emitting 
diodes (LEDs) and can be used to activate the PIT conjugates.
    Potential Commercial Applications: Anti-cancer therapy.
    Competitive Advantages:
     Highly specific to cancer cells
     Do not affect surrounding normal cells
     Negligible toxicity
     Enhancement of therapeutic effects when administered in 
combination with one or more other therapeutic agents
     Possible to follow the cell killing process in real time, 
using fluorescence lifetime imaging
    Development Stage: In vivo data available (animal).
    Inventors: Hisataka Kobayashi and Peter L. Choyke (NCI).
    Publications:
    1. Mitsunaga M, et al. Immediate in vivo target-specific cancer 
cell death after near infrared photoimmunotherapy. BMC Cancer 2012 Aug 
8;12: 345. [PMID 22873679]
    2. Mitsunaga M, et al. Near-infrared theranostic photoimmunotherapy 
(PIT): Repeated exposure of light enhances the effect of 
immunoconjugate. Bioconjug Chem. 2012 Mar 21;23(3):604-9. [PMID 
22369484]
    3. Mitsunaga M, et al. Cancer cell-selective in vivo near infrared 
photoimmunotherapy targeting specific membrane molecules. Nat Med. 2011 
Nov6;17(12):1685-91. [PMID 22057348]
    Intellectual Property:
     HHS Reference No. E-205-2010/2--PCT Application No. PCT/
US2012/044421 filed 27 Jun 2012
     HHS Reference No. E-250-2010/1--U.S. Application No. 13/
180,111 filed 11 Jul 2011
     HHS Reference No. E-205-2010/0--U.S. Provisional 
Application No. 61/636,079 filed 09 Jul 2010
    Licensing Contact: Uri Reichman, Ph.D., MBA; 301-435-4616; 
reichmau@mail.nih.gov.

    Dated: January 18, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-01620 Filed 1-25-13; 8:45 am]
BILLING CODE 4140-01-P