[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30731-30732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13084]



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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.

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.

Vaccines for Protection Against Mucosatropic Infections

    Description of Invention: The invention offered for licensing and 
commercial development relates to the field of Vaccines. More 
specifically, the invention describes novel compositions, strategy and 
methods that can effectively induce local mucosal immune response (e.g. 
in a female genital tract that is infected with a mucosatropic 
pathogen), as well as systemic immune response. The method comprises 
administrating to the treated subject at least two (2) immunogenic 
compositions in a prime-boost regimen, each comprising an effective 
amount of an immunogen derived from the pathogen. The first composition 
is administered to the epithelial surface of the subject in combination 
with one or more agents or treatment to disrupt the epithelial surface 
(e.g.nonoxobol-9 or depot medroxyprogesterone acetate). The second 
immunogenic composition is administered systemically. The first 
composition is typically a papillomavirus pseudovirion (PsV) comprising 
a polynucleotide that encodes proteins on the mucosatropic pathogen. 
The PsV has shown to confer tropism for the basal epithelium and is 
uniquely capable of eliciting strong immune response at this 
environment. The immunogenic composition that is administered 
systemically is typically selected from one of the following groups: 
(a) A live attenuated virus (e.g. poxivirus) expressing a protein or 
proteins of the infecting pathogen, (b) a DNA vector encoding proteins 
of the pathogen, or (c) an immunogenic polypeptide from the pathogen.
    Applications: Vaccines against infectious pathogens, particularly 
against mucosatropic pathogens and pathogens such as HIV, HCV, HSV or 
HPV that initiate infection at mucosal sites including the female 
genital tract.
    Advantages:
     The unique properties of the PsV vaccine vectors have 
shown to confer tropism for the basal epithelium, and are several folds 
more effective as mucosal vaccines compared with other DNA vaccines 
such as naked or vectored DNA.
     The use of epithelial disruptive agent enhances the 
effectiveness of the PsV vaccines in mucosal tissues.
     The unique vaccine compositions and the prime-boost 
vaccination strategy assure both local (i.e. vaginal track) and 
systemic immunity.
    Development Status: Proof of principle has been demonstrated. 
Animal efficacy data in mice and primates is available.
    Market: The market for vaccines against infectious diseases is 
huge. The present invention is unique as it can be used as a vaccine 
platform with diverse number of applications and in multiple vaccines. 
The technology can provide mucosal/local and systemic immunization 
simultaneously and thus it may prove to be extremely powerful against 
mucosatropic pathogens. The commercial potential of the present 
invention is thus vast.
    Inventors: Genoveffa Franchini, Christopher B. Buck, John T. 
Schiller, et al. (NCI)
    Relevant Publications:
    1. Barney S. Graham, John T. Schiller, Christopher B. Buck, Jeffrey 
N. Roberts, Teresa R. Johnson, John D. Nicewonger, Rhonda C. Kines, and 
Man Chen. Use of HPV Virus-like Particles to Deliver Gene-based 
Vaccines. USPA 12/863,572 filed July 19, 2010. Priority date January 
19, 2008 (USPA 61/022,324) and PCT/US2009/031600, filed January 21, 
2009 (HHS Reference No. E-077-2008/0).
    2. CB Buck, DV Pastrana, DR Lowy, JT Schiller. Efficient 
intracellular assembly of papillomaviral vectors. J Virol. 2004 
Jan;78(2):751-757. [PubMed: 14694107].
    3. BS Graham, RC Kines, KS Corbett, J Nicewonger, TR Johnson, M 
Chen, D LaVigne, JN Roberts, N Cuburu, JT Schiller, and CB Buck. 
Mucosal delivery of human papillomavirus pseudovirus-encapsidated 
plasmids improves the potency of DNA vaccination. Mucosal Immunol. 2010 
Sep;3(5):475-486. [PubMed: 20555315].
    Patent Status: U.S. Provisional Application No. 61/447,499 filed 28 
Feb 2011 (HHS Reference No. E-112-2011/0-US-01), entitled 
``Cervicovaginal Vaccination With Papillomavirus Pseudovirions for 
Protection Against Mucosatropic Infection''.
    Licensing Status: Available for licensing and commercial 
development.
    Licensing Contacts:
     Uri Reichman, PhD, MBA; 301-435-4616; [email protected].
     John Stansberry, PhD; 301-435-5236; [email protected].
    Collaborative Research Opportunity: The Center for Cancer Research, 
Vaccine Branch, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize Vaccines for Protection Against Mucosatropic 
Infections. Please contact John Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

Peptide Therapeutics for Cardiac Failure

    Description of Invention: Available for licensing are therapeutic 
peptides that induce heart contractions without affecting blood 
pressure during cardiac failure. During cardiac failure, the heart 
suffers a decrease in contraction force, which weakens the heart's 
ability to deliver blood. Interestingly, the failing heart also retains 
an ability to increase its contraction force. This represents the 
theoretical basis for treatment of heart failure with positive 
inotropic agents, which increase heart contractility. Currently 
available positive inotropic agents include catecholamines such as 
epinephrine, Milrinone, and beta-receptor agonists. However, these 
treatments demonstrate negative side effects including increased blood 
pressure as well as heart attack.
    Investigators at the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development have developed therapeutic peptides 
designated as Serpinin and its derivative pGlu-Serpinin. These peptides 
act via a signaling pathway independent from the classical receptor-
mediated adrenergic pathway and as a result, they can increase heart 
contractility without affecting blood pressure. These peptides 
represent a novel pharmacological approach in the treatment of cardiac 
failure.

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    Applications: Treatment for cardiac failure.
    Advantages: Therapies that increase heart contractions without 
affecting blood pressure.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Market:
     In the U.S., cardiac failure affects an estimated 5.7 
million people and there are approximately 550,000 newly diagnosed 
cases per year.
     Cardiac failure was estimated to result in direct and 
indirect costs of $37.2 billion in the United States in 2009.
     Heart failure is responsible for 11 million physician 
visits each year, and more hospitalizations than all forms of cancer 
combined.
    Inventors: Y. Peng Loh (NICHD) and Bruno Tota (University of 
Calabria).
    Relevant Publications: None. Future publications are being 
contemplated.
    Patent Status: U.S. Provisional Application No. 61/427,243 filed 27 
Dec 2010 (HHS Reference No. E-001-2011/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
[email protected].
    Collaborative Research Opportunity: The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, Section on 
Cellular Neurobiology, is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate, or commercialize the use of serpinin and pyroglu-serpinin in 
treatment of heart failure. Please contact Joseph Conrad at 301-435-
3107 or [email protected] for more information.

Alpha-Glucosidase Chaperones and Inhibitors for Treatment of Pompe 
Disease and Type 2 Diabetes

    Description of Invention: Scientists at the NIH have discovered 
small molecules that can act as chaperones and correct the misfolding 
of mutated alpha-glucosidase enzyme. Pompe disease is caused by 
deficiency or dysfunction of alpha-glucosidase. The only FDA-approved 
treatment of Pompe disease is enzyme replacement, which in this case 
costs approximately $300,000 per year and elicits an immune reaction in 
most patients that limits clinical utility.
    In addition, scientists at the NIH have discovered small molecule 
inhibitors of alpha glucosidase enzyme. Alpha glucosidase converts 
carbohydrates into monosaccharides. Inhibition of this conversion is 
useful for type 2 diabetes. Three FDA-approved inhibitors of alpha 
glucosidase exist but all have low efficacy:side effect ratios.
    Applications:
     Therapeutic for Pompe disease.
     Therapeutic for type 2 diabetes.
    Advantages:
     Potentially more affordable and less immunogenic than the 
current therapeutic for Pompe disease.
     Potentially better efficacy:side effect ratios than 
existing type 2 diabetes therapeutics.
    Development Status: Early stage.
    Market: Pompe disease occurs in 1 in every 40,000 births (http://www.ninds.nih.gov/disorders/pompe/pompe.htm).
    Inventors: Juan J. Marugan, Ehud M. Goldin, Noel T. Southall, Wei 
Zheng, Jingbo Xiao, Ellen Sidransky, and Omid Motabar (NHGRI).
    Patent Status: U.S. Provisional Patent Application No. 61/409/697 
filed 03 November 2010 (HHS Reference No. E-256-2010/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Steve Standley, PhD; 301-435-4074; 
[email protected].

Mouse IL-12p40 Expressing Cell Line

    Description of Invention: The subject invention is a recombinant 
human 293T cell line that expresses mouse IL-12p40 protein to high 
levels. IL-12p40 is a subunit of both Interleukin-12 (IL-12) and IL-23; 
however, it can also be expressed as a monomer (IL-12p40) and as a 
homodimer (IL-12p80). IL-12p40 is produced mainly by antigen presenting 
cells such as macrophages, neutrophils, microglia, and dendritic cells 
in response to pathogens or inflammatory agents. It is an 
immunostimulatory messenger molecule that can disseminate in the body 
and signal the presence of a pathogen. The role of IL-12p40 is still 
being elucidated. This cell line produces and secretes mouse IL-12p40 
proteins that have post-translational modifications similar to native 
IL-12p40 protein, overcoming an issue that is seen with IL-12p40 
protein expressed in bacterial, insect, or hamster cells.
    Applications: Production of mouse IL-12p40 for research 
applications.
    Advantages: IL-12p40 protein is expressed in human cell line, so 
post-translational modifications are similar to native protein.
    Development Status: In vitro data can be provided upon request.
    Market: Research reagent.
    Inventors: Nevil J. Singh (NIAID).
    Patent Status: HHS Reference No. E-247-2010/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018, 
[email protected].

    Dated: May 20, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-13084 Filed 5-25-11; 8:45 am]
BILLING CODE 4140-01-P