[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Page 53886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23311]


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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: Peter Soukas, J.D., 301-594-8730; 
[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unpublished patent applications.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.

Recombinant Respiratory Syncytial Virus Challenge Strain

Description of Technology

    RSV is the most important viral agent of severe respiratory tract 
disease worldwide, especially in infants and young children, and it 
also causes severe disease in the elderly and in immunocompromised 
individuals. There are no licensed vaccines or antivirals suitable for 
routine use.
    This invention relates to a reverse genetics system and cDNA-
derived virus for a contemporary wild-type clinical isolate of RSV of 
antigenic subgroup A, termed RSV strain A/Maryland/001/11, that was 
isolated in 2011 from an adult with respiratory illness. The genomic 
sequence was determined. A reverse genetics system was created encoding 
a recombinant, replication competent RSV that contains a codon-
optimized G ORF, which was done to stabilize the cDNA for replication 
in bacteria. Because this virus was generated by reverse genetics, it 
is a ``clean'' virus with a well-defined passage history. Clinical 
study material of this challenge virus has been manufactured and is 
available for use as an U.S. Food and Drug Administration (FDA) 
regulated Investigational New Drug (IND) in clinical studies in adult 
volunteers within and outside of the United States. Preliminary 
clinical data confirmed that this virus efficiently infects and 
replicates in 95% of study participants pre-selected for pre-existing 
RSV antibody titers in the bottom 50% of the range. The challenge virus 
causes mild upper respiratory illness in the majority of infected 
participants, typical for RSV illness in otherwise healthy adults. This 
provides a suitable challenge system for evaluating antivirals, as well 
as vaccines for older children and adults. This also could be used for 
developing live-attenuated RSV vaccine candidates based on this 
contemporary strain, using the stabilized point mutations, stabilized 
codon-deletions, and gene-deletions that were previously used in RSV 
strain A2.
    This invention relates to a reverse genetics system and the encoded 
RSV vaccine challenge strain that infects and causes disease in RSV-
experienced adults and is available for antiviral and vaccine research.
    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

     Vaccine development
     Viral diagnostics
     Vaccine research

Competitive Advantages

     Ease of manufacture
     Clinical trial material
     Low-cost vaccines
     Intranasal administration/needle-free delivery

Development Stage

     In vivo data assessment (human)
    Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID).
    Intellectual Property: HHS Reference No. E-235-2018-0.
    Licensing Contact: Peter Soukas, J.D., 301-594-8730; 
[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 for development of a vaccine for 
respiratory or other infections. For collaboration opportunities, 
please contact Peter Soukas, J.D., 301-594-8730; [email protected].

    Dated: October 12, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2018-23311 Filed 10-24-18; 8:45 am]
 BILLING CODE 4140-01-P