[Federal Register Volume 79, Number 121 (Tuesday, June 24, 2014)]
[Notices]
[Pages 35756-35758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14650]


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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.

AMA1-RON2 Complex-Based Vaccine Against Malaria

    Description of Technology: This technology relates to a malaria 
vaccine composed of a protein complex of Apical Membrane Antigen (AMA1) 
and rhoptry neck protein 2 (RON2) with an adjuvant. AMA1 is a crucial 
component of the Plasmodium invasion machinery and is a leading 
candidate for antimalarial vaccine development.

[[Page 35757]]

AMA1-based vaccines have shown ability to block red cell invasion in in 
vitro assays, but protection has so far not translated to in vivo human 
infections. NIAID investigators have demonstrated that interaction 
between AMA1 and RON2 (or peptide thereof) is essential for malaria 
parasites to successfully enter human red blood cells (RBCs). 
Vaccination with un-complexed AMA1 and RON2 did not protect against 
lethal malaria. However, vaccination with a pre-formed AMA1-RON2 
complex, highlighted in this technology, produced antibodies that 
protected against lethal malaria in an in vivo mouse model (P. yoelli) 
and blocked the entry of human malaria parasites into RBCs in vitro. 
Additionally, the inhibitory antibody response induced by the AMA1-RON2 
complex was greater than AMA1 alone or when AMA1 and RON2 proteins were 
administered in a un-complexed form.
    Immunization using the AMA1-RON2 complex of this technology 
represents a candidate for an effective malaria vaccine against 
multiple Plasmodium species.
    Potential Commercial Applications: Malaria vaccine.
    Competitive Advantages: Lower-cost malarial prevention for 
developing/developed countries.
    Development Stage:
     Early-stage.
     In vitro data available.
     In vivo data available (animal).
    Inventors: Prakash Srinivasan and Louis Miller (NIAID).
    Publications:
    1. Srinivasan P, et al. Binding of Plasmodium merozoite proteins 
RON2 and AMA1 triggers commitment to invasion. Proc Natl Acad Sci U S 
A. 2011 Aug 9;108(32):13275-80. [PMID 21788485].
    2. Srinivasan P, et al. Disrupting malaria parasite AMA1-RON2 
interaction with a small molecule prevents erythrocyte invasion. Nat 
Commun. 2013;4:2261. [PMID 23907321].
    Intellectual Property: HHS Reference No. E-066-2013/0--U.S. 
Provisional Application No. 61/841,479 filed 01 Jul 2013.
    Licensing Contact: Edward (Tedd) Fenn; 424-297-0336; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize MA1-RON2 vaccine by providing well 
established human adjuvants and clinical trial funding. For 
collaboration opportunities, please contact Mala Dutta, Ph.D. at 240-
627-3684 or [email protected].

A Novel Therapeutic Technology for Treating Glioblastoma Multiforme and 
Other Cancers

    Description of Technology: Glioblastoma Multiforme (GBM) is the 
most common and devastating form of brain cancer. Despite existing 
conventional therapies, including an initial surgical resection 
followed by chemotherapy and radiation, GBM is currently incurable with 
a median survival of approximate 15 months and a two-year survival of 
30%.
    This invention discloses a novel therapeutic technology to treat 
GBM by using induced electric fields that are applied to the brain 
tissue via an array of coils placed over the scalp. The device of the 
invention consists of a portable current generator with a customized 
coil array. It has been shown to reduce pain for patients and be easy 
to use.
    Potential Commercial Applications:
     Treatment of patients with Glioblastoma Multiforme (GBM).
     Clinical research device for Glioblastoma Multiforme.
     Possible application to other cancers.
     Research tool to study mechanisms of electric field 
effects on mitosis and other cell and tissue processes.
     May be useful in improving effectiveness and enhancing 
delivery of adjuvant therapies.
    Competitive Advantages:
     Portable.
     Painless.
     Easy to operate.
     No scalp burns that occur when using current electrodes.
    Development Stage:
     Early-stage.
     Prototype.
    Inventor: Peter J. Basser (NICHD).
    Publications:
    1. Silva S, et al. Elucidating the mechanisms and loci of neuronal 
excitation by transcranial magnetic stimulation using a finite element 
model of a cortical sulcus. Clin Neurophysiol. 2008 Oct;119(10):2405-
13. [PMID 18783986].
    2. Salvador R, el al. Determining which mechanisms lead to 
activation in the motor cortex: A modeling study of transcranial 
magnetic stimulation using realistic stimulus waveforms and sulcal 
geometry. Clin Neurophysiol. 2011 Apr;122(4):748-58. [PMID 21035390].
    3. Miranda PC, et al. Tissue heterogeneity as a mechanism for 
localized neural stimulation by applied electric fields. Phys Med Biol. 
2007 Sep 21;52(18):5603-17. [PMID 17804884].
    4. Miranda PC, et al. The electric field induced in the brain by 
magnetic stimulation: A 3-D finite-element analysis of the effect of 
tissue heterogeneity and anisotropy. IEEE Trans Biomed Eng. 2003 
Sep;50(9):1074-85. [PMID 12943275].
    5. Basser PJ. Focal magnetic stimulation of an axon. IEEE Trans 
Biomed Eng. 1994 Jun;41(6):601-6. [PMID 7927380]
    6. Miranda PC, et al. Modeling the current distribution during 
transcranial direct current stimulation. Clin Neurophysiol. 2006 
Jul;117(7):1623-9. [PMID 16762592].
    Intellectual Property: HHS Reference No. E-187-2012/0--US Patent 
Application No. 61/954,494 filed 17 March 2014.
    Licensing Contact: John Stansberry, Ph.D.; 301-435-5236; 
[email protected].
    Collaborative Research Opportunity: The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development, Program on 
Pediatric Imaging and Tissue Sciences, Section on Tissue Biophysics and 
Biomimetics, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize technology that uses a.c. current electrodes 
to try to kill GBM cells. For collaboration opportunities, please 
contact Alan Hubbs, Ph.D. at [email protected].

Broadly Neutralizing Human Anti-HIV Monoclonal Antibody 10E8 and 
Related Antibodies Capable of Neutralizing Most HIV-1 Strains

    Description of Technology: The uses for human anti-HIV monoclonal 
antibody 10E8 and its variants include passive immunization, 
therapeutic vaccination, and the development of vaccine immunogens. 
10E8 is one of the most potent HIV-neutralizing antibodies isolated and 
it neutralizes up to 98% of diverse HIV-1 strains. 10E8 is specific to 
the membrane-proximal external region (MPER) of the HIV envelope 
protein gp41 and 10E8 is orthogonal to other anti-HIV antibodies. In 
combination with other antibodies 10E8 may provide an antibody response 
that neutralizes nearly all strains of HIV-1. Additionally, 10E8 
effectively induces antibody-dependent cellular cytotoxicity (ADCC) 
indicating its potential use for therapeutic vaccine strategies. 
Further, 10E8 is a tool for immunogen design and validation of 
immunogen structure.

[[Page 35758]]

    NIAID is currently developing certain embodiments of 10E8 for 
clinical use. Therefore, for some fields of use, NIH will evaluate a 
license applicant's capabilities and experience in advancing similar 
technologies through the regulatory process. This technology is not 
eligible for the NIH's start-up license program.
    Potential Commercial Applications:
     Passive protection to prevent HIV infection.
     Passive protection to prevent mother-to-infant HIV 
transmission.
     Topical microbicide to prevent HIV infection.
     Gene-based vectors for anti-gp41 antibody expression.
     Therapeutic for the elimination of HIV infected cells that 
are actively producing virus.
    Competitive Advantages:
     One of the most potent Human broadly-neutralizing anti HIV 
antibodies isolated to date.
     Broad reactivity and high affinity to most HIV-1 strains.
     Activity is highly complementary to existing broadly 
neutralizing antibodies, such as CD4 binding site antibodies.
     Not auto-reactive.
    Development Stage:
     In vitro data available.
     In vivo data available (animal).
    Inventors: Mark Connors, Jinghe Huang, Leo Laub, John Mascola, Gary 
Nabel, Peter Kwong, Baoshan Zhang, Rebecca Rudicell, Ivelin Geogiev, 
Yongping Yang, Jiang Zhu, and Giled Oflek.
    Publication: Huang J, et al. Broad and potent neutralization of 
HIV-1 by a gp41-specific human antibody. Nature. 2012 Nov 
15;491(7424):406-12. [PMID 23151583].
    Intellectual Property: HHS Reference Nos. E-253-2011/0,1,2,3--
Neutralizing gp41 antibodies and their use.
     US Provisional Patent Application Nos. 61/556,660 filed 07 
Nov 2011; 61/672,708 filed 17 Jul 2012; and 61/698,480 filed 07 Sep 
2012.
     PCT Patent Application No. PCT/US2012/063958 (Publication 
No. WO/2013/070776) filed 07 Nov 2012; and corresponding applications 
filed in BR, CN, EP, IN, RU, US, and ZA.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., MBA; +1 301-
435-4507; [email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize 10E8-related vaccines or 
immunotherapies. For collaboration opportunities, please contact Bill 
Ronnenberg at +1 240-627-3726 or [email protected].

    Dated: June 18, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-14650 Filed 6-23-14; 8:45 am]
BILLING CODE 4140-01-P