Notice2021-24028
Government-Owned Inventions; Availability for Licensing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 4, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 211 (Thursday, November 4, 2021)</title>
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[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60894-60895]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-24028]
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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;
<a href="/cdn-cgi/l/email-protection#deaebbaabbacf0adb1abb5bfad9eb0b7b6f0b9b1a8"><span class="__cf_email__" data-cfemail="a6d6c3d2c3d488d5c9d3cdc7d5e6c8cfce88c1c9d0">[email protected]</span></a>. 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unpublished patent applications.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 Chimeric Bovine/Human Parainfluenza Virus 3 Expressing
SARS-CoV-2 Spike Protein and Its Use
Description of Technology
Vaccines for SARS-CoV-2 are increasingly available under emergency
use authorizations; however, indications are currently limited to
individuals twelve (12) years or older. They also involve intramuscular
immunization, which does not directly stimulate local immunity in the
respiratory tract, the primary site of SARS-CoV-2 infection, shedding
and spread. While the major burden of COVID-19 disease is in adults,
infection and disease also occur in infants and young children,
contributing to viral transmission. Therefore, the development of safe
and effective pediatric COVID-19 vaccines is important. Ideally, a
vaccine should be effective as a single dose, should induce mucosal
immunity with the ability to restrict SARS-CoV-2 infection and
respiratory shedding, and should easily coordinate with vaccines for
other illnesses, such as HPIV3.
The live-attenuated vaccine candidates are based on a recombinant
chimeric bovine/human parainfluenza virus 3 (rB/HPIV3) vector
expressing prefusion-stabilized versions of the Severe Acute
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike (S) protein. The
B/HPIV3-SARS CoV-2 vaccine candidates are designed to be administered
intranasally by drops or spray to infants and young children. The
vaccines are expected to induce durable and broad systemic and
respiratory mucosal immunity against SARS-CoV-2 and HPIV3.
Immunogenicity and protective efficacy against SARS-CoV-2 challenge was
confirmed in experimental animals including non-human primates. Based
on experience with this B/HPIV3 platform and other live-attenuated PIV
vaccine candidates in previous pediatric clinical studies, the present
candidates are anticipated to be well-tolerated in humans, including
infants and young children, and are available for clinical evaluation.
The National Institute of Allergy and Infectious Diseases has extensive
experience and capability in
[[Page 60895]]
evaluating live-attenuated respiratory virus vaccine candidates in
pediatric clinical studies, including PIV vaccine candidates, and
opportunity for collaboration exists.
This technology is available for nonexclusive 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
<bullet> Viral diagnostics
<bullet> Vaccine research
Competitive Advantages
<bullet> Ease of manufacture
<bullet> B cell and T cell activation
<bullet> Low-cost vaccines
<bullet> Intranasal administration/needle-free delivery
Development Stage
<bullet> In vivo data assessment (animal)
Inventors: Ursula Buchholz (NIAID), Shirin Munir (NIAD), Cyril Le
Nouen (NIAID), Xueqiao Liu (NIAID), Cindy Luongo (NIAID), Peter Collins
(NIAID).
Intellectual Property: HHS Reference No. E-239-2020-0--U.S.
Provisional Application No. 63/180,534, filed April 27, 2021.
Licensing Contact: Peter Soukas, J.D., 301-496-2644;
<a href="/cdn-cgi/l/email-protection#1161746574633f627e647a7062517f78793f767e67"><span class="__cf_email__" data-cfemail="770712031205590418021c160437191e1f59101801">[email protected]</span></a>.
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; <a href="/cdn-cgi/l/email-protection#79091c0d1c0b570a160c12180a39171011571e160f"><span class="__cf_email__" data-cfemail="8dfde8f9e8ffa3fee2f8e6ecfecde3e4e5a3eae2fb">[email protected]</span></a>.
Dated: October 29, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-24028 Filed 11-3-21; 8:45 am]
BILLING CODE 4140-01-P
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