[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