[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23014-23015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10156]


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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 invention listed below is owned by an agency of the U.S. 
Government and is available for licensing 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: Dr. Dianca Finch, 240-669-5503; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD, 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Products for Treatment and Prevention of Ebola Zaire Disease

Description of Technology

    Scientists at the NIAID Vaccine Research Center have developed 
human

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monoclonal neutralizing antibodies for treatment and prevention of 
Ebola Zaire disease. The monoclonal antibodies (mAbs) bind to different 
regions of the Ebola glycoprotein that are unique for these two mAbs. 
Alone or in combination, the mAbs prevent or reverse Ebola Zaire virus 
disease in non-human primates. Nonclinical studies have demonstrated 
complete protection against disease with a single antibody and complete 
protection against viremia by addition of a second antibody. The 
current nonclinical pharmacology demonstrates a favorable 
pharmacokinetic profile and there is a first-in-time human clinical 
trial projected for 2017. The anticipated indications for this 
technology include pre-and post-symptomatic treatment, and pre-and 
post-exposure prophylaxis.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

     Therapeutics
     Diagnostics

Competitive Advantages

     Favorable pharmacokinetic profile
     Favorable manufacturing
     Complete protection against disease with a single unique 
mAb
     Complete protection with fewer administrations and/or 
lower doses than any other mAb
     Complete protection against viremia with two antibodies

Development Stage

     In vivo data available (animal)
     Entering first-in-time human clinical trial (2017)
    Inventors: Nancy J. Sullivan (NIAID); Barney S. Graham (NIAID); 
Julie Ledgerwood (NIAID); Daphne A. Stanley (NIAID); Antonio 
Lanzavecchia (IRB) Davide Corti (IRB); John Trefry (USAMRIID/WR)

Publications

Corti D, et al., Protective monotherapy against lethal Ebola virus 
infection by a potently neutralizing antibody. Science. 2016 Mar 
18;351:1339-42. [PMID: 26917593]
Misasi J, et al., Structural and molecular basis for Ebola virus 
neutralization by protective human antibodies. Science. 2016 Mar 
18;3511343-6. [PMID: 26917592].

Intellectual Property

    HHS Reference No. E-045-2015--U.S. Provisional Application No. 62/
087,087, filed December 3, 2014; PCT Application No. PCT/US2015/060733, 
filed November 13, 2015 HHS Reference No. E-278-2016- U.S. Provisional 
Application No.62,080,094, filed November 14, 2014; PCT Application No. 
PCT/IB2015/002342, filed November 13, 2015
    Licensing Contact: Dr. Dianca Finch, 240-669-5503; 
[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 products for treatment and 
prevention of Ebola Zaire disease. For collaboration opportunities, 
please contact Dr. Dianca Finch, 240-669-5503; [email protected].

    Dated: May 9, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-10156 Filed 5-18-17; 8:45 am]
 BILLING CODE 4140-01-P