[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Pages 3834-3836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01186]



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.

Improved Therapeutic Immunotoxins

    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-discriminate therapies, such as 
chemotherapy or radiation therapy. Unfortunately, the continued 
administration of immunotoxins often leads to a reduced patient 
response due to the formation of neutralizing antibodies against 
immunogenic epitopes contained within the toxin. One such toxin is 
Pseudomonas exotoxin A (PE). To improve the therapeutic effectiveness 
of PE-based immunotoxins through multiple rounds of drug 
administration, NIH inventors previously reduced the immunogenicity of 
PE through the removal of B-cell and T-cell epitopes by mutation or 
deletion. Although this resulted in immunotoxins with improved 
therapeutic activity, the modifications to reduce immunogenicity 
decreased the activity of PE. Through further specific modification, 
the inventors have now created a PE that has reduced immunogenicity 
with limited loss of activity. The resulting PE-based immunotoxins have 
increased resistance to the formation of neutralizing antibodies, while 
retaining greater activity, and are expected to have improved 
therapeutic efficacy.
    Potential Commercial Applications:
     Essential 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, ovarian cancer, breast cancer, and head and neck cancers
    Competitive Advantages:

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     New modifications allow for the reduction of 
immunogenicity with less loss of activity
     Less immunogenic immunotoxins with greater activity 
results in improved therapeutic efficacy by permitting multiple rounds 
of administration in humans
     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
     In vivo data available (animal)
    Inventors: Ira H. Pastan et al. (NCI)
    Intellectual Property:
     HHS Reference No. E-771-2013/0--U.S. Provisional Patent 
Application No. 61/887,418 filed 06 October 2013
     HHS Reference No. E-771-2013/1--U.S. Provisional Patent 
Application No. 61/908,464 filed 25 November 2013
    Related Technologies:
     HHS Reference No. E-117-2011/0--PCT Patent Publication WO 
     HHS Reference No. E-174-2011/0--PCT Patent Publication WO 
     HHS Reference No. E-263-2011/0--PCT Patent Publication WO 
     HHS Reference No. E-269-2009/0--US Patent Publication 
20120263674 A1
     HHS Reference No. E-292-2007/0--US Patent Publication US 
20100215656 A1
     HHS Reference No. E-262-2005/0--US Patent Publication US 
20090142341 A1
     Multiple additional patent families
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Laboratory of Molecular Biology, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize a 
new immunotoxin target. For collaboration opportunities, please contact 
John D. Hewes, Ph.D., at [email protected].

Respiratory Syncytial Virus Vaccines Based on G Protein Subunit

    Description of Technology: The invention pertains to cross-
neutralizing vaccines against human respiratory syncytial virus 
subtypes A and B employing immunogenic G protein subunit and fragments 
thereof that are preferably derived from the ectodomain. Various 
candidate G protein subunits are provided spanning amino acid sequence 
67-298 of RSV G protein and combinations thereof. Also envisioned 
within the scope of this invention are tandem repeated recombinant G 
protein subunit vaccines that provide higher immunogenicity. 
Recombinant G protein can be codon optimized for expression in various 
hosts (e.g., mammalian cells or E. coli).
    Potential Commercial Applications:
     Childhood vaccines
    Competitive Advantages: Cross neutralizing
    Development Stage:
     In vitro data available
    Inventors: Surender Khurana and Hana Golding (FDA)
    Intellectual Property: HHS Reference No. E-735-2013/0--U.S. 
Provisional Patent Application No. 61/863,100 filed 02 December 2013
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
[email protected]
    Collaborative Research Opportunity: The Food and Drug 
Administration, Center for Biologics Evaluation and Research, is 
seeking statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate or commercialize 
RSV G protein subunit vaccine. For collaboration opportunities, please 
contact Surender Khurana, Ph.D., at 301-827-0739.

Pyrrole Derivative Inhibitors of Wip1 for the Treatment of Cancer

    Description of Technology: Wild-type p53-induced phosphatase 1 
(Wip1) is an enzyme that is overexpressed in a number of human cancers, 
including breast cancer, neuroblastoma and ovarian cancer. Wip1 has a 
suppressive effect on the tumor suppressor p53, allowing the 
unregulated growth that is associated with tumors. Inhibiting Wip1 
could restore the tumor suppressor activity of p53, leading to the 
arrest of unregulated tumor growth and induction of apoptosis. This 
suggests that inhibitors of Wip1 could be of therapeutic value for the 
treatment of cancer.
    This invention concerns novel small molecules that can inhibit Wip1 
activity. The particular structure of the small molecules allows for 
specific targeting to Wip1. Specifically, the structure is a derivative 
of a pyrrole ring having five (5) points of substitution. These small 
molecules have the ability to significantly inhibit Wip1 phosphatase 
activity at the micromolar level, with substitutions of biphenyl groups 
having the highest level of inhibition. Based on their potential 
ability to restore the activity of a tumor suppressor protein and 
activate apoptosis, these small molecules may be useful in the 
treatment of cancers that overexpress Wip1.
    Potential Commercial Applications:
     Treatment of cancer, including but not limited to breast 
cancer, ovarian cancer and neuroblastoma
     Can be used either alone or in combination with other 
known anti-cancer therapeutics
    Competitive Advantages:
     Structure of the inhibitor allows specific targeting of 
Wip1, possibly leading to fewer undesired effects during treatment
     The molecules are designed to be more stable and 
effectively penetrate mammalian cells
     The current lack of Wip1 inhibitors can lead the 
occupation of a significant position in the cancer therapeutic market 
with a first-in-class drug
    Development Stage: Early-stage
    Inventors: Daniel H. Appella et al. (NIDDK)
    Publication: Hayashi R, et al. Optimization of a cyclic peptide 
inhibitor of Ser/Thr phosphatase PPM1D (Wip1). Biochemistry. 2011 May 
31;50(21):4537-49. [PMID 21528848]
    Intellectual Property: HHS Reference No. E-537-2013/0--U.S. 
Provisional Patent Application No. 61/865,845 filed 14 August 2013
    Related Technology: HHS Reference No. E-302-2007/0--US Patent 
Application No. 12/675,167 filed 25 February 2010
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected]

Methods of Treating or Preventing Pruritis (Itch)

    Description of Technology: This technology provides a novel method 
of treating or preventing pruritis (itch) using natriuretic polypeptide 
b (Nppb) blocking agents. Itch (also known as pruritis) is a sensation 
that may be perceived as an unpleasant skin irritation and may drive an 
urge to scratch. Conditions such as, for example, psoriasis, atopic 
dermatitis, renal failure, liver cirrhosis and some cancers may cause 
persistent itch. Itch is triggered by somatosensory neurons expressing 
the ion channel TRPV1 (transient receptor potential cation channel 
subfamily V member 1). The inventors of this technology show that the 
Nppb is expressed in a subset of TRPV1 neurons and found that Nppb-/- 
mice selectively lose all behavioral responses to itch-inducing agents. 
Nppb triggered potent scratching when

[[Page 3836]]

injected intrathecally in wild-type and Nppb-/- mice. Itch responses 
were blocked by toxin-mediated ablation of Nppb-receptor-expressing 
cells, but a second neuropeptide, gastrin-releasing peptide, still 
induced strong responses in the toxin-treated animals.
    Potential Commercial Applications:
     Therapeutics for preventing or treating pruritis/itching.
     Screening of novel Nppb blocking agents.
    Competitive Advantages: A new mode of treating itch and itch 
induced conditions using selective Nppb antagonists.
    Development Stage:
     In vitro data available
    Inventors: Mark A. Hoon and Santosh K. Mishra (NIDCR)
    Publication: Mishra SK, Hoon MA. The cells and circuitry for itch 
responses in mice. Science. 2013 May 24;340(6135):968-71. [PMID 
    Intellectual Property: HHS Reference No. E-485-2013/0--U.S. 
Provisional Patent Application No. 61/912,334 filed 05 December 2013
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; [email protected]

Recombinant Stabilized Prefusion Protein of Respiratory Syncytial Virus 
for Use as a Subunit Vaccine

    Description of Technology: The invention, a stabilized recombinant 
prefusion F protein (pre F), is a candidate subunit vaccine for 
Respiratory Syncytial Virus (RSV). Pre-F is stabilized in the prefusion 
conformation and displays epitopes not present in postfusion F protein. 
Several potent RSV neutralizing antibodies bind pre F, but not 
postfusion F. Therefore, immunization with pre F may elicit an immune 
response superior to the response generated by postfusion F.
    NIH researchers have engineered pre F to expose an antigenic site 
0, which is targeted by extremely potent RSV neutralizing antibodies. 
Structure-based design yielded several stabilized variants of pre F 
that maintained exposure of antigenic site 0 when subjected to extremes 
of pH, osmolality and temperature.
    Preclinical in vivo data on stabilized pre F is available. 
Immunization of mice and macaques with antigenic site 0 stabilized pre 
F variants elicited high levels of RSV specific neutralizing activity.
    Potential Commercial Applications: Vaccine for Respiratory 
Syncytial Virus
    Competitive Advantages:
     Vaccine stably exposes antigenic site in RSV F that 
permits generation of potent RSV neutralizing antibodies.
     There is currently no RSV vaccine on the market.
    Development Stage:
     In vivo data available (animal)
    Inventors: Jason S. McLellan, Barney S. Graham, Peter D. Kwong (all 
    1. McLellan JS, et al. Structure of RSV fusion glycoprotein trimer 
bound to a prefusion-specific neutralizing antibody. Science 2013 May 
31;340(6136):1113-7. [PMID 23618766]
    2. McLellan JS, et al. Structure-based design of a fusion 
glycoprotein vaccine for respiratory syncytial virus. Science 2013 Nov 
1:342 (6158)592-8. [PMID 24179220]
    Intellectual Property:
     HHS Reference No. E-081-2013/0--U.S. Application No. 61/
780,910 filed 13 March 2013
     HHS Reference No. E-081-2013/1--U.S. Application No. 61/
798,389 filed 15 March 2013
     HHS Reference No. E-081-2013/2--U.S. Application No. 61/
857,613 filed 23 July 2013
     HHS Reference No. E-081-2013/3--U.S. Application No. 61/
863,909 filed 09 August 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 an 
RSV vaccine based on pre F, a stabilized recombinant RSV F protein. For 
collaboration opportunities, please contact Rosemary C. Walsh, Ph.D. at 
301-541-3528 or [email protected].

    Dated: January 16, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-01186 Filed 1-22-14; 8:45 am]