Government-Owned Inventions; Availability for Licensing
| Citation | 86 FR 36757 |
| Record Number | 2021-14820 |
| Published date | 13 July 2021 |
| Section | Notices |
| Court | National Institutes Of Health |
Federal Register, Volume 86 Issue 131 (Tuesday, July 13, 2021)
[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Disclosure Agreement will be required to receive copies of unpublished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
