[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22936-22937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08154]


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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#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copies of unpublished patent applications.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


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