[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Notices]
[Pages 53548-53549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21940]



[[Page 53548]]

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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.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

Live Attenuated Vaccine To Prevent Disease Caused by West Nile Virus

    Description of Technology: West Nile virus (WNV) has recently 
emerged in the U.S. and is considered a significant emerging disease 
that has embedded itself over a considerable region of the U.S. WNV 
infections have been recorded in humans as well as in different 
animals. From 1999-2014, WNV killed 1,765 people in the U.S. and caused 
severe disease in more than 41,762 others. This project is part of 
NIAID's comprehensive emerging infectious disease program.
    The methods and compositions of this invention provide a means for 
prevention of WNV infection by immunization with attenuated, 
immunogenic viral vaccines against WNV. The invention involves a 
chimeric virus form comprising parts of WNV and Dengue virus. 
Construction of the hybrids and their properties are described in 
detail in multiple publications. The WNV chimeric vaccine does not 
target the central nervous system, which would be the case in an 
infection with wild type WNV. Importantly, two successful Phase I 
clinical trials were recently carried out with the vaccine. The live 
attenuated WNV vaccine is safe, well-tolerated, and immunogenic in 
healthy adult volunteers. Furthermore, the vaccine virus may also be 
considered for use as a safe reagent handled at bio-safety level 2 
facilities for WNV diagnosis and surveillance.

Potential Commercial Applications

 Human West Nile vaccine
 Veterinary West Nile vaccine
 West Nile Virus diagnostics
 West Nile Virus therapeutics

Competitive Advantages

 Low cost of manufacture
 Proven chimeric vaccine technology
 Phase I clinical data available

Development Stage

 In vivo data available (animal)
 In vivo data available (human)

    Inventors: Alexander G. Pletnev, Robert M. Chanock, Joseph R. 
Putnak, Brian R. Murphy, Joseph E. Blaney, Stephen S. Whitehead (all of 
NIAID)

Publications

1. Pletnev AG, et al. West Nile virus/dengue type 4 virus chimeras 
that are reduced in neurovirulence and peripheral virulence without 
loss of immunogenicity or protective efficacy. Proc Natl Acad Sci 
USA. 2002 Mar 5;99(5):3036-41. [PMID 11880643]
2. Pletnev AG, et al. Molecularly engineered live-attenuated 
chimeric West Nile/dengue virus vaccines protect rhesus monkeys from 
West Nile virus. Virology. 2003 Sep 15;314(1):190-5. [PMID 14517072]
3. Hanley KA, et al. Infectivity of West Nile/dengue chimeric 
viruses for West Nile and dengue mosquito vectors. Vector Borne 
Zoonotic Dis. 2005 Spring;5(1):1-10. [PMID 15815144]
4. Pletnev AG, et al. Chimeric West Nile/dengue virus vaccine 
candidate: preclinical evaluation in mice, geese and monkeys for 
safety and immunogenicity. Vaccine. 2006 Sep 29;24(40-41):6392-404. 
[PMID 16831498]
5. Durbin AP, et al. The live attenuated chimeric vaccine rWN/
DEN4delta30 is well-tolerated and immunogenic in healthy flavivirus-
na[iuml]ve adult volunteers. Vaccine. 2013 Nov 19;31(48):5772-7. 
[PMID 23968769]
6. Maximova OA, et al. Assurance of neuroattenuation of a live 
vaccine against West Nile virus: a comprehensive study of 
neuropathogenesis after infection with chimeric WN/DEN4delta30 
vaccine in comparison to two parental viruses and a surrogate 
flavivirus reference vaccine. Vaccine. 2014 May 30;32(26):3187-97. 
[PMID 24736001]

    Intellectual Property: HHS Reference No. E-357-2001/1--

 US Patent No. 8,778,671 issued 15 Jul 2014
 US Patent Application No. 14/305,572 filed 16 Jun 2014
 Various international patents/applications issued/pending

    Licensing Contact: Peter Soukas; 301-435-4646; [email protected].

Three-Dimensional Curved Catheter for Right Atrial Appendage Traversal

    Description of Technology: Available for licensing and commercial 
development is a three-dimensionally configured curved catheter for 
safe traversal of the right atrial appendage (RAA). The device is 
configured to optimize one-way access of the pericardial space through 
the right atrium and into the RAA reducing the risk of coronary 
lacerations. Specifically the curved catheter is best described in 
three segments: a proximal segment, a transitional segment and a distal 
segment; the transition segment having a clockwise spiral shaped 
curvature. When inserted into a patient, the proximal segment is 
positioned within the inferior vena cava, the transition segment 
extends across the caval-atrial junction and curves rightward, forward, 
and upward such that the catheter abuts a right lateral wall of the 
right atrium, and the distal segment curves leftward, forward, and 
upward from the transition segment through the right atrium such that 
the catheter abuts an anterior wall of the right atrium adjacent to the 
RAA. The catheter is configured to guide a coaxial puncturing device to 
through the superior left sulcal wall of the RAA.

Potential Commercial Applications

 Left atrial appendage ligation
 Circumferential tricuspid annuloplasty
 Epicardial ablation
Competitive Advantages: Reduced risk of coronary or myocardial 
laceration

Development Stage

 Early-stage
 Prototype

    Inventors: Robert Lederman (NHLBI), Toby Rogers (NHLBI), Nasser 
Rafiee (Mehr Medical), Adam Greenbaum (Henry Ford Hospital), William 
O'Neill (Henry Ford Hospital).
    Intellectual Property: HHS Reference No. E-078-2015--US Provisional 
Patent Application 62/162,453 filed May 15, 2015.
    Related Technologies: HHS Reference No. E-027-2013; HHS Reference 
No. E-115-2013; HHS Reference No. E-018-2014; and HHS Reference Nos. E-
068-2014/E-124-2014.

[[Page 53549]]

    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
[email protected]
    Collaborative Research Opportunity: The National Heart, Lung and 
Blood Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize devices for pericardial interventional 
procedures. For collaboration opportunities, please contact Peg Koelble 
at 301-594-4095 or [email protected].

Pseudomonas Exotoxin A With Modified Furin Cleavage Site

    Description of Technology: Immunotoxins kill cancer cells while 
allowing healthy, essential cells to survive. As a result, patients 
receiving immunotoxins are less likely to experience the deleterious 
side-effects associated with non-specific therapies such as 
chemotherapy. In order to make an effective immunotoxin, three 
components are generally required: A targeting domain, a furin cleavage 
site (FCS), and a toxic payload molecule (such as Pseudomonas exotoxin 
A (PE)). The purpose of the FCS is to allow the toxin domain to be 
processed by the target cell so that it can exert its toxic effect. 
This technology concerns the engineering of FCS in order to improve the 
efficacy of specific immunotoxins having distinct targeting domains. 
Several novel FCS have been generated which can be substituted for the 
native FCS in PE. By using specific FCS with different targeting 
moieties, it is possible to engineer an immunotoxin that is better 
suited to treating specific types of cancer.

Potential Commercial Applications

 Essential for the payload component of immunotoxins
 Treatment of any disease associated with increased or 
preferential expression of a specific cell surface receptor
 Specific diseases include hematological cancers, lung cancer 
(including mesothelioma), ovarian cancer, breast cancer, and head and 
neck cancers

Competitive Advantages

 Designing specific furin cleavage sites for particular 
immunotoxins can improve cleavage and enhance toxin efficacy, resulting 
in improved therapeutic effectiveness
 Targeted therapy decreases non-specific killing of healthy, 
essential cells, resulting in fewer non-specific side-effects and 
healthier patients

    Development Stage: In vitro data available.
    Inventors: Ira Pastan et al. (NCI).

Publications

1. Weldon JE, et al. Designing the furin-cleavable linker in 
recombinant immunotoxins based on Pseudomonas exotoxin A. Bioconjug 
Chem. 2015 Jun 17;26(6):1120-8. [PMID 25997032]
2. Weldon JE, et al. A protease-resistant immunotoxin against CD22 
with greatly increased activity against CLL and diminished animal 
toxicity'' Blood. 2009 Apr 16;113(16):3792-800. [PMID 18988862]

    Intellectual Property: HHS Reference No. E-197-2015/0-US-01--US 
Provisional Application No. 62/163,667 filed May 19, 2015.

Related Technologies

 HHS Reference E-262-2005/0
 HHS Reference E-292-2007/0
 HHS Reference E-269-2009/0
 HHS Reference E-174-2011/0
 HHS Reference E-263-2011/0
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected].
    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 
Pseudomonas Exotoxin A with Modified Furin Cleavage Site. For 
collaboration opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

    Dated: August 31, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 2015-21940 Filed 9-3-15; 8:45 am]
BILLING CODE 4140-01-P