Government-Owned Inventions; Availability for Licensing, 14952 [2020-05294]
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14952
Federal Register / Vol. 85, No. 51 / Monday, March 16, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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;
peter.soukas@nih.gov. 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to receive copies of unpublished patent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.
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
Method of Vaccination With an
Attenuated RSV Vaccine Formulation
Description of Technology: Acute
respiratory infections during early
childhood constitute a major human
health burden. Human respiratory
syncytial virus (RSV) is the most
common and important viral cause of
severe acute pediatric respiratory
infections worldwide. Mortality due to
RSV in the post-neonatal (28 days to 1
year old) population is second only to
malaria. It is estimated that RSV causes
34 million lower respiratory tract
infections, 4 million hospitalizations,
and 66,000–199,000 deaths every year
in children less than 5 years of age.
Most mortality occurs in the developing
world where clinical care is less
accessible. Mortality is low in the
developed countries, but the morbidity
is substantial: In the United States
alone, RSV is associated with an
estimated 132,000–172,000
hospitalizations annually in children
less than 5 years old. There is not yet
available a vaccine or an effective
antiviral drug suitable for routine use.
VerDate Sep<11>2014
18:29 Mar 13, 2020
Jkt 250001
This application claims a method of
vaccinating a human subject against
Respiratory Syncytial Virus (RSV) by
administering a composition comprising
an immunogenic amount of a
recombinant RSV particle to the subject.
An embodiment of the composition
comprising the recombinant RSV
particle was evaluated as a live
intranasal vaccine in adults, RSVseropositive children and RSVseronegative children. When results in
RSV-seronegative children were
compared to those achieved with the
previous leading live attenuated RSV
candidate vaccine, vaccine virus
shedding was significantly more
restricted, yet the post-vaccination RSVneutralizing serum antibody achieved
was significantly greater. Surveillance
during the subsequent RSV season
showed that several RSV-seronegative
recipients had substantial rises of RSVneutralizing serum antibodies indicative
of exposure to RSV, and yet without
reported RSV-associated illness,
suggesting that the vaccine was
protective yet primed for anamnestic
responses to RSV. Thus, the
composition comprising the
recombinant RSV particle was
intrinsically superior at eliciting
protective antibody in the subjects.
Surprisingly, a single dose of the
composition was sufficient to provide
the greater antibody response and
protective effect in seronegative and/or
RSV-naive infants and children of less
than about 24 months of age. This was
an unexpected result, as it is currently
anticipated that vaccination against RSV
using a live, attenuated RSV vaccine
will require administration of multiple
doses, at least two or three at a
minimum, in a single vaccination
season to provide protective result.
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 therapeutics
• Viral diagnostics
• Vaccine research
Competitive Advantages:
• Ease of manufacture
• Adjuvant unnecessary
• Favorable safety profile in clinical
trials
Development Stage:
• In vivo data assessment (human)
Inventors: Ursula Buchholz (NIAID),
Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–067–2016–0 —U.S. Provisional
Application Nos. 62/251,030, filed
November 4, 2015, 62/259,472, filed
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
November 24, 2015, and 62/263,405,
filed December 4, 2015, PCT Patent
Application Number PCT/US2016/
060672, filed November 4, 2016,
European Patent Application Number
1694904.9, filed November 4, 2016
(pending), United States Patent
Application Number 15/773,653, filed
May 4, 2018 (pending).
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; peter.soukas@nih.gov.
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;
peter.soukas@nih.gov.
Dated: March 10, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2020–05294 Filed 3–13–20; 8:45 am]
BILLING CODE 4140–01–P
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Comment Request
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E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Page 14952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05294]
[[Page 14952]]
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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.
-----------------------------------------------------------------------
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.
Method of Vaccination With an Attenuated RSV Vaccine Formulation
Description of Technology: Acute respiratory infections during
early childhood constitute a major human health burden. Human
respiratory syncytial virus (RSV) is the most common and important
viral cause of severe acute pediatric respiratory infections worldwide.
Mortality due to RSV in the post-neonatal (28 days to 1 year old)
population is second only to malaria. It is estimated that RSV causes
34 million lower respiratory tract infections, 4 million
hospitalizations, and 66,000-199,000 deaths every year in children less
than 5 years of age. Most mortality occurs in the developing world
where clinical care is less accessible. Mortality is low in the
developed countries, but the morbidity is substantial: In the United
States alone, RSV is associated with an estimated 132,000-172,000
hospitalizations annually in children less than 5 years old. There is
not yet available a vaccine or an effective antiviral drug suitable for
routine use.
This application claims a method of vaccinating a human subject
against Respiratory Syncytial Virus (RSV) by administering a
composition comprising an immunogenic amount of a recombinant RSV
particle to the subject. An embodiment of the composition comprising
the recombinant RSV particle was evaluated as a live intranasal vaccine
in adults, RSV-seropositive children and RSV-seronegative children.
When results in RSV-seronegative children were compared to those
achieved with the previous leading live attenuated RSV candidate
vaccine, vaccine virus shedding was significantly more restricted, yet
the post-vaccination RSV-neutralizing serum antibody achieved was
significantly greater. Surveillance during the subsequent RSV season
showed that several RSV-seronegative recipients had substantial rises
of RSV-neutralizing serum antibodies indicative of exposure to RSV, and
yet without reported RSV-associated illness, suggesting that the
vaccine was protective yet primed for anamnestic responses to RSV.
Thus, the composition comprising the recombinant RSV particle was
intrinsically superior at eliciting protective antibody in the
subjects. Surprisingly, a single dose of the composition was sufficient
to provide the greater antibody response and protective effect in
seronegative and/or RSV-naive infants and children of less than about
24 months of age. This was an unexpected result, as it is currently
anticipated that vaccination against RSV using a live, attenuated RSV
vaccine will require administration of multiple doses, at least two or
three at a minimum, in a single vaccination season to provide
protective result.
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 therapeutics
Viral diagnostics
Vaccine research
Competitive Advantages:
Ease of manufacture
Adjuvant unnecessary
Favorable safety profile in clinical trials
Development Stage:
In vivo data assessment (human)
Inventors: Ursula Buchholz (NIAID), Peter Collins (NIAID).
Intellectual Property: HHS Reference No. E-067-2016-0 --U.S.
Provisional Application Nos. 62/251,030, filed November 4, 2015, 62/
259,472, filed November 24, 2015, and 62/263,405, filed December 4,
2015, PCT Patent Application Number PCT/US2016/060672, filed November
4, 2016, European Patent Application Number 1694904.9, filed November
4, 2016 (pending), United States Patent Application Number 15/773,653,
filed May 4, 2018 (pending).
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: March 10, 2020.
Wade W. Green,
Acting Deputy Director, Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases.
[FR Doc. 2020-05294 Filed 3-13-20; 8:45 am]
BILLING CODE 4140-01-P
