[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Page 8306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02916]


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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: Dianca Finch, Ph.D., 240-669-5503; 
[email protected]. Licensing information and copies of the U.S. 
patent application 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to receive copies of unpublished patent applications.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:

Ebola Virus Glycoprotein-Specific Monoclonal Antibodies and Uses 
Thereof Description of Technology

    Ebola virus is a large, negative-strand RNA virus composed of 7 
genes encoding viral proteins, including a single glycoprotein (GP). 
The virus is responsible for causing Ebola virus disease (EVD), 
formerly known as Ebola hemorrhagic fever (EHF), in humans. In 
particular, Bundibugyo (BDBV), Zaire (EBOV), and Sudan (SUDV) species 
have been associated with large outbreaks of EVD in Africa and reported 
case fatality rates of up to 90%. Transmission of Ebola virus to humans 
is not yet fully understood but is likely due to incidental exposure to 
infected animals. EVD spreads through human-to-human transmission, with 
infection resulting from direct contact with blood, secretions, organs 
or other bodily fluids of infected people, and indirect contact with 
environments contaminated by such fluids.
    EVD has an incubation period of 2 to 21 days (7 days on average, 
depending on the strain) followed by a rapid onset of non-specific 
symptoms such as fever, extreme fatigue, gastrointestinal complaints, 
abdominal pain, anorexia, headache, myalgias and/or arthralgias.
    While prior outbreaks of EVD have been localized to regions of 
Africa, there is a potential threat of spread to other countries given 
the frequency of international travel. The 2014 outbreak in West Africa 
was first recognized in March 2014, and as of April 13, 2016, the 
number of cases far exceeded the largest prior EVD outbreak with a 
combined total (suspected, probable, and laboratory-confirmed) 28616 
cases and 11310 deaths (case fatality rate = 39.5%). The largest 
previous outbreak occurred in Uganda in 2000-2001 with 425 cases and 
224 deaths (case-fatality rate = 53%).
    Viruses in the Filoviridae family are also categorized as potential 
threats for use as biological weapons due to ease of dissemination and 
transmission, and high levels of mortality. Currently, no effective 
therapies or FDA-licensed vaccines exist for any member of Filoviridae 
family of viruses.
    Researchers at the Vaccine Research Center (VRC) of the National 
Institute of Allergy and Infectious Diseases (NIAID) developed eight 
high-affinity human monoclonal antibodies, specifically EboV.YD.01, 
EboV.YD.02, EboV.YD.03, and EboV.YD.04, EboV.YD.05, EboV.YD.06, 
EboV.YD.07 and EboV.YD.08 which bind with nanomolar affinity against 
Ebola virus glycoprotein. The human monoclonal antibodies have been 
assessed by functional assays, epitope mapping, affinity measurements 
and in vitro neutralization assays.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    Potential Commercial Applications:
     Prevention of acquisition of Ebola Zaire virus.
     Antibody therapy for people exposed to Ebola Zaire virus.
     Diagnostics for Ebola Zaire virus.
    Competitive Advantages:
     High-affinity neutralizing antibodies (mAbs), targeting 
Ebola virus (EBOV) glycoprotein from a human Ebolavirus vaccine.
     Currently, there are no Food and Drug Administration 
(FDA)-approved vaccines or therapeutics available for prevention, post-
exposure, or treatment for EBOV.
     The EboV.YD.01-EboV.YD.08 antibodies can be combined with 
other biologicals and vaccines for prevention and therapy of Ebola 
Zaire infection/disease.
    Development Stage: Preclinical Research.
    Inventors: Nancy J. Sullivan, Ph.D. (NIAID); John Misasi, Ph.D. 
(NIAID).
    Intellectual Property: HHS Reference Number E-061-2018 includes 
U.S. Provisional Patent Application Number 62/782,809, filed 12/20/
2018, and PCT Application Number PCT/US2019/067423, filed 12/19/2019.
    Licensing Contact: To license this technology, please contact 
Dianca Finch, Ph.D., 240-669-5503; [email protected].

    Dated: February 4, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-02916 Filed 2-12-20; 8:45 am]
 BILLING CODE 4140-01-P