Notice2022-08154
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
April 18, 2022
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
<html>
<head>
<title>Federal Register, Volume 87 Issue 74 (Monday, April 18, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22936-22937]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08154]
-----------------------------------------------------------------------
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., 301-496-2644;
<a href="/cdn-cgi/l/email-protection#3f4f5a4b5a4d114c504a545e4c7f51565711585049"><span class="__cf_email__" data-cfemail="adddc8d9c8df83dec2d8c6ccdeedc3c4c583cac2db">[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
(NIAID), 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copies of unpublished patent applications.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:
Expression of Prefusion-Stabilized Spike S Glycoprotein of SARS CoV-2
From Avian Paramyxovirus Type 3 (APMV3)
Description of Technology: Severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) emerged in 2019 as the causative agent of
coronavirus disease 2019 (COVID-19) and has created a pandemic and
global crisis in public health. Vaccines for SARS-CoV-2 are
increasingly available under emergency use authorizations; however,
authorizations for use are currently limited to individuals five (5)
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. Ideally,
a vaccine should be effective as a single dose and should induce
systemic and mucosal immunity with the ability to restrict SARS-CoV-2
infection and respiratory shedding.
The application relates to a live virus-vectored intranasal vaccine
candidate to prevent infection and transmission of SARS-CoV-2. Avian
paramyxovirus type 3 (APMV3) was used as a vaccine vector to express
the spike (S) protein stabilized in prefusion conformation by six
proline substitutions (APMV3/S-6P). The S protein was from the first
available SARS-CoV-2 sequence. A lack of pre-existing immunity in
humans and attenuation by host range restriction make APMV3 a vector of
interest. Unlike avian paramyxovirus 1 (Newcastle Disease Virus), APMV3
is not a significant pathogen in poultry. The APMV3/S-6P vaccine is
expected to induce durable and broad systemic and respiratory mucosal
immunity against SARS-CoV-2. In the hamster model, a single intranasal
dose of APMV3/S-6P induced a strong serum neutralizing antibody
response to the vaccine-matched SARS-CoV-2 isolate WA1, and a strong
serum IgG and IgA response to S protein and its receptor-binding
domain. Serum antibodies of APMV3/S-6P-immunized hamsters effectively
neutralized SARS-CoV-2 of lineages B.1.1.7 (Alpha) and B.1.351(Beta).
Immunized hamsters challenged with SARS-CoV-2, strain WA1, did not
exhibit weight loss and lung inflammation, and SARS-CoV-2 replication
in the upper and lower respiratory tract was low or undetectable. Thus,
a single intranasal dose of APMV3/S-6P fully protected hamsters from
SARS-CoV-2 challenge, suggesting that APMV3/S-6P is suitable for
clinical development.
Based on experience with this and other live-attenuated virus-
vectored vaccine candidates in previous clinical studies, the present
candidate is anticipated to be well-tolerated in humans. The National
Institute of Allergy and Infectious Diseases has extensive experience
and capability in evaluating live-attenuated respiratory
[[Page 22937]]
virus vaccine candidates in pediatric clinical studies, 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 (NIAID), Cyril Le
Nouen (NIAID), Hongsu Park (NIAID), Cindy Luongo (NIAID), Peter Collins
(NIAID).
Intellectual Property: HHS Reference No. E-238-2020-0--U.S.
Provisional Application No. 63/280,884, filed November 18, 2021.
Licensing Contact: Peter Soukas, J.D., 301-496-2644;
<a href="/cdn-cgi/l/email-protection#2a5a4f5e4f580459455f414b596a444342044d455c"><span class="__cf_email__" data-cfemail="cdbda8b9a8bfe3bea2b8a6acbe8da3a4a5e3aaa2bb">[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#2d5d4859485f035e4258464c5e6d434445034a425b"><span class="__cf_email__" data-cfemail="2252475647500c514d57494351624c4b4a0c454d54">[email protected]</span></a>.
Dated: April 12, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2022-08154 Filed 4-15-22; 8:45 am]
BILLING CODE 4140-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.