[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11546-11547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03872]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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unpublished patent applications.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.

Improved Live-Attenuated Vaccine for Respiratory Syncytial Virus (RSV) 
Bearing Codon-Pair Deoptimized NS1, NS2, N, P, M and SH Genes and 
Additional Point Mutations in the P Gene

    Description of Technology:
    RSV is the most important viral agent of severe respiratory disease 
in infants and young children worldwide and also causes substantial 
morbidity and mortality in older adults. RSV is estimated to cause more 
than 33 million lower respiratory tract illnesses, three million 
hospitalizations, and nearly 200,000 childhood deaths worldwide 
annually, with many deaths occurring in developing countries. However, 
despite the prevalence of RSV and the dangers associated with 
infection, no RSV vaccine has been successfully developed to date. 
Accordingly, there is a public health need for RSV vaccines.
    This vaccine candidate comprises live RSV that was attenuated by 
subjecting the protein-coding sequences of the viral NS1, NS2, N, P, M, 
and SH genes to codon-pair deoptimization, which resulted in many 
nucleotide substitutions that were silent at the amino acid level but 
conferred attenuation. In addition, specific amino acid substitutions 
were identified and introduced into the P protein that improved 
attenuation and genetic stability. Genetic stability was confirmed in 
vitro, and attenuation was confirmed in experimental animals.

[[Page 11547]]

    This live-attenuated RSV vaccine is designed to be administered 
intranasally by drops or spray to infants and young children. Based on 
experience with other live-attenuated RSV vaccine candidates, the 
present candidates are anticipated to be well tolerated in humans and 
are available for clinical evaluation. The National Institute of 
Allergy and Infectious Diseases has extensive experience and capability 
in evaluating live-attenuated RSV vaccine candidates in pediatric 
clinical studies, and opportunity for collaboration exists.
    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:

 Viral diagnostics
 Vaccine research

    Competitive Advantages:

 Ease of manufacture
 B cell and T cell activation
 Low-cost vaccines
 Intranasal administration/needle-free delivery

    Development Stage:

 In vivo data assessment (animal)

    Inventors: Cyril Le Nouen (NIAID), Ursula Buchholz (NIAID), Peter 
Collins (NIAID).
    Intellectual Property: HHS Reference No. E-104-2020-0--U.S. 
Provisional Application No. 63/023,949, filed May 13, 2020.
    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: February 18, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-03872 Filed 2-24-21; 8:45 am]
BILLING CODE 4140-01-P