[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60894-60895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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; 
[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unpublished patent applications.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.

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

     Viral diagnostics
     Vaccine research

Competitive Advantages

     Ease of manufacture
     B cell and T cell activation
     Low-cost vaccines
     Intranasal administration/needle-free delivery

Development Stage

     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; 
[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: 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