[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Page 24322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11255]


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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: Amy Petrik, Ph.D., 240-627-3721; 
[email protected]. Licensing information and copies of the U.S. 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unpublished patent applications.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.

Middle East Respiratory Syndrome Coronavirus Antibodies

Description of Technology

    Middle East Respiratory Syndrome coronavirus (MERS-CoV) causes a 
highly lethal pulmonary infection with ~35% mortality. Currently there 
are no prophylactic measures or effective therapies. Inventors at the 
Vaccine Research Center of the National Institute of Allergy and 
Infectious Diseases have identified and developed neutralizing 
monoclonal antibodies (nMAbs) against the MERS-CoV. This invention 
describes antibodies that target the Spike (S) glycoprotein on the 
coronavirus surface, which mediates viral entry into host cells. These 
novel antibodies target different regions of the S protein, and when 
administered in combination, reduce the possibility of viral escape. In 
preclinical testing, these nMAbs have demonstrated potent protective 
effects, preventing death, viral replication in the lower airways and 
severe disease in challenge studies with mice. In addition, these nMAbs 
have potential application for use in assays for detecting MERS-CoV S 
protein in infected patients or animals.
    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

    Monoclonal antibodies developed against multiple regions of the 
coronavirus spike protein have potential application in the prevention 
and treatment of MERS-CoV. There is also potential application for 
their use as a diagnostic tool of infection.

Competitive Advantages

     In vitro models, the combinations of antibodies have been 
demonstrated to be effective in reducing viral escape.
     In vivo data in animal models demonstrated a potent 
ability to control infection.
     Applicable in diagnostic assays.

Development Stage

     In vivo data available (animal)
    Inventors: Barney Graham (NIAID), Wing-Pui Kong (NIAID), Kayvon 
Modjarrad (NIAID), Lingshu Wang (NIAID), Wei Shi (NIAID), Michael 
Gordon Joyce (NIAID), Masaru Kanekiyo (NIAID), John Mascola (NIAID).
    Intellectual Property: HHS Reference No. E-239-2014, U.S. 
Provisional Patent Application Number 62/120,353 filed February 25, 
2015, PCT Patent Application PCT/US2016/019395 filed February 24, 2016, 
Europe Patent Application Number 16711059.2 filed February 24, 2016, 
South Korea Patent Application Number 10-2017-7027105 filed September 
25, 2017, Saudi Arabia Patent Application Number 5173382168 filed 
August 21, 2017, and U.S. Patent Application Number 15/553,466 filed 
August 24, 2017.
    Licensing Contact: Amy Petrik Ph.D., 240-627-3721; 
[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 MERS-CoV monoclonal antibodies. For 
collaboration opportunities, please contact Amy Petrik, Ph.D., 240-627-
3721; [email protected].

    Dated: May 14, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-11255 Filed 5-24-18; 8:45 am]
 BILLING CODE 4140-01-P