[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36757-36758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14820]


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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., 301-496-2644; 
[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

[[Page 36758]]

Disclosure Agreement will be required to receive copies of unpublished 
patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.

Mononegavirales Vectors Expressing Chimeric Antigens

Description of Technology

    Human respiratory syncytial virus (RSV) continues to be the leading 
viral cause of severe acute lower respiratory tract disease in infants 
and children worldwide, and also is an important cause of morbidity and 
mortality in the elderly. A licensed vaccine or antiviral drug suitable 
for routine use remains unavailable. This invention relates to the use 
of murine pneumonia virus (MPV--previously known as pneumonia virus of 
mice, PVM--of family Pneumoviridae) as a vaccine vector expressing the 
RSV fusion protein F, the most important protective antigen of RSV. MPV 
is not a human pathogen and is not restricted by immunity to common 
human viruses. MPV replicates in the superficial epithelial cells of 
the respiratory mucosa and is expected to be attenuated in humans based 
on the strong host range restriction observed in non-human primates. To 
generate these MPV/RSV vector vaccine candidates, the RSV F ORF was 
codon optimized, placed under the control of MPV transcription signals, 
and inserted at the first (rMPV-F1), third (rMPV29 F3), or fourth 
(rMPV-F4) gene position of a version of the MPV genome that contained a 
codon-pair optimized L polymerase gene. The recovered viruses 
replicated in vitro as efficiently as the empty vector, with stable 
expression of RSV F protein. Replication and immunogenicity of rMPV-F1 
and rMPV-F3 were evaluated in rhesus macaques following administration 
by the combined intranasal and intratracheal routes. Both viruses 
replicated at low levels in the upper and lower respiratory tract, 
maintained stable RSV F expression, and induced similarly high levels 
of RSV-neutralizing serum antibodies that reached peak titers by 
fourteen (14) days post-vaccination. Thus, rMPV provides a highly 
attenuated yet immunogenic vector for the expression of RSV F protein, 
with potential application in RSV-na[iuml]ve and RSV-experienced 
populations. RSV F was expressed in the wild-type form, but can readily 
be engineered to be stabilized in the highly immunogenic prefusion 
form, as has been done with parainfluenza virus vectors.
    The invention relates to live, chimeric non-human Mononegavirales 
vectors that allow a cell to express at least one protein from at least 
one human pathogen as well as compositions comprising the vectors, 
methods and kits for eliciting an immune response in a host, and 
methods of making the vectors.
    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
 Multivalent live attenuated vaccines
 B cell and T cell activation
 Low-cost vaccines

Development Stage

 In vivo data assessment (animal)
    Inventors: Shirin Munir (NIAID), Linda Brock (NIAID), Ursula 
Buchholz (NIAID), Peter Collins (NIAID).
    Intellectual Property: HHS Reference No. E-018-2018/0--U.S. 
Provisional Application No. 62/661,320, filed April 23, 2018 (expired), 
PCT Patent Application No. PCT/US2019/028771, filed April 23, 2019 
(expired), Taiwanese Patent Application No. 108114132, filed April 23, 
2019 (pending), Brazilian Patent Application No. BR112020021652-6, 
filed October 22, 2020 (pending), Australian Patent Application No. 
2019261570, filed October 21, 2020 (pending), Canadian Patent 
Application No. 3097888, filed October 20, 2020 (pending), Chinese 
Patent Application No. 201980039372.6, filed December 15, 2020 
(pending), European Patent Application No. 19729386.3, filed November 
13, 2020 (pending), Indian Patent Application No. 20204706248, filed 
October 23, 2020, Japanese Patent Application No. 2020-558967, filed 
October 22, 2020, South Korean Patent Application No. 2020-7033157, 
filed November 18, 2020, and United States Patent Application No. 17/
049,916, filed October 22, 2020.
    Licensing Contact: Peter Soukas, J.D., 301-496-2644; 
[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., 301-496-2644; [email protected].

    Dated: July 8, 2021.
Anna V. Ganelina,
Senior Technology Transfer and Patenting Specialist, Technology 
Transfer and Intellectual Property Office, National Institute of 
Allergy and Infectious Diseases.
[FR Doc. 2021-14820 Filed 7-12-21; 8:45 am]
BILLING CODE 4140-01-P