[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9521-9522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03044]


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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: Chris Kornak at 240-627-3705 or 
[email protected]. Licensing information may be obtained by 
communicating with 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unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Replication-Competent Adenovirus Type 4 SARS-CoV-2 Vaccines and Their 
Use

Description of Technology

    NIAID has produced recombinant adenovirus type 4 (Ad4), SARS-CoV-2 
spike, vectors for administration to humans. These recombinant vaccines 
permit rapid development of high levels of neutralizing antibodies to 
SARS-CoV-2 in experimental animals. This vaccine is designed to improve 
the durability of the immune response by inducing mucosal and systemic 
immunity. Further, this system should be incredibly simple and 
efficient when producing vaccine at scale. 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

 Vaccine composition(s)

Competitive Advantages

 Stimulates a durable immune response;
 Induction of mucosal and systemic immunity;
 Potential for transmission interruption;
 Intranasal administration minimizes the impact of pre-existing 
immunity;
 Notable improvement for manufacturing yield and cost, ease of 
administration, and distribution as compared to current candidates.

    Inventor: Mark Connors, M.D. (NIAID)
    Publications: Matsuda et al. Journal of Clinical Investigation, 
2021. (https://doi.org/10.1172/JCI140794). Matsuda et al., Science 
Immunology 2019 (https://doi.org/10.1126/sciimmunol.aau2710).
    Intellectual Property: HHS Reference E-055-2021; Application No. 
63/138,221.
    Licensing Contact: To license this technology, please contact Chris 
Kornak at [email protected].

[[Page 9522]]

    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 this invention. Interested parties 
should have the ability to manufacture viruses under cGMP, suitable for 
Phase 1-2 testing by NIAID. Capabilities for further clinical 
development, and experience with Phase 3 testing, licensure, and 
rollout are preferred. For collaboration opportunities, please contact 
Chris Kornak at [email protected].

    Dated: January 29, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-03044 Filed 2-12-21; 8:45 am]
BILLING CODE 4140-01-P