[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Page 89482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29605]


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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: 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will be required to receive copies of unpublished patent applications.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.

Zika Virus Vaccines

Description of Technology

    Zika virus (ZIKV) is a flavivirus transmitted by mosquitos that is 
strongly linked to neurological complications including Guillain-
Barr[eacute] syndrome, meningoencephalitis, and microcephaly. The 
association between active ZIKV infection during pregnancy and 
microcephaly and intrauterine growth retardation in the fetus has been 
confirmed in murine models of ZIKV infection.
    Scientists at NIAID have developed nucleic acid-based vaccine 
candidates to prevent ZIKV infection in humans. The current lead 
candidate vaccine is a plasmid DNA vaccine demonstrated to accord 
protection in preclinical models and is undergoing clinical trial 
evaluation. Nucleic acid-based vaccines have been developed previously 
for West Nile virus, another flavivirus similar to Zika (J.E. 
Ledgerwood, et al. J. Infect. Dis. (2011) 203 (10): 1396-1404). 
Immunization with the nucleic acid ZIKV vaccine candidate results in 
production of noninfectious virus like particles (VLPs) made of ZIKV 
proteins. These ZIKV VLPs elicit an immune response which includes 
neutralizing antibodies to ZIKV.
    Other preclinical ZIKV vaccine candidates include mRNA, protein, 
and noninfectious VLPs.
    NIAID is continuing development of these vaccine candidates. The 
DNA-based ZIKV vaccine candidate is currently in clinical trials. 
Consequently, for some fields of use, NIAID will evaluate a license 
applicant's capabilities and experience in advancing similar 
technologies through the regulatory process.
    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. This technology is not eligible for NIH's start up 
license.

Potential Commercial Applications:
     Prevention of Zika virus infection
Competitive Advantages:
     There is currently no licensed Zika virus vaccine
Development Stage:
     Currently, DNA-based vaccine candidate in Phase I clinical 
trial
     Phase II clinical trial planned for early 2017 for DNA-
based vaccine candidate
     Other candidates are in pre-clinical development

    Inventors: Barney S. Graham (NIAID), Theodore C. Pierson (NIAID), 
Kimberly A. Dowd (NIAID), John R. Mascola (NIAID), Wing-Pui Kong 
(NIAID), Sung-Youl Ko (NIAID), Eun Sung Yang (NIAID), Wei Shi (NIAID), 
Lingshu Wang (NIAID), Christina R. Demaso (NIAID), Rebecca S. Pelc 
(NIAID), Adrian Creanga (NIAID), Julie Ledgerwood (NIAID), William 
Schief (The Scripps Research Institute), Sebastian Ramisch (The Scripps 
Research Institute), Leda Castilho (Federal University of Rio de 
Janeiro)
    Publications: K.A. Dowd, et al., Science, 354, 237-240 (2016).
    DOI: 10.1126/science.aai9137.
    Intellectual Property: U.S. Patent Application No. 62/396,613 filed 
September 19, 2016 (HHS Reference No. E-181-2016/0-US-01).
    Licensing Contact: Dr. Amy Petrik, 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 Zika virus vaccine technologies. For 
collaboration opportunities, please contact Dr. Amy Petrik, 240-627-
3721; [email protected].

    Dated: December 5, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2016-29605 Filed 12-9-16; 8:45 am]
BILLING CODE 4140-01-P