[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Notices]
[Pages 85895-85896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27112]


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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: Brian Bailey, Ph.D.; 240-669-5128 or 
301-201-9217; [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unpublished information related to the invention.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:

Enhanced Immune Response With Stabilized Norovirus VLPs: A Next-
Generation Vaccine Approach

    Description of Technology: This technology includes a novel 
advancement in developing vaccines targeting norovirus, tailored 
specifically for a more robust and effective response. It centers 
around an improved version of Virus-Like Particles (VLPs) uniquely 
engineered for greater stability and efficacy. These enhanced VLPs are 
designed to remain intact even when faced with the body's immune 
responses, overcoming a key limitation of previous vaccine designs. 
This stability is crucial in ensuring the vaccine's effectiveness, 
particularly in individuals with more robust immune systems who have 
shown limited response to traditional vaccines. Additionally, the 
modified VLPs are likely more resistant to degradation, making them a 
more reliable and durable solution in vaccination campaigns. This 
innovation could be a significant step in offering a more effective 
vaccine option for widespread use.
    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:
     Enhanced Norovirus Vaccination: Specially designed to 
improve the effectiveness of vaccines against norovirus, particularly 
in individuals with previously low response rates to traditional 
vaccines.
     Broad-Scale Immunization Programs: Suitable for large-
scale public health initiatives due to its increased

[[Page 85896]]

stability and durability, potentially reducing the frequency of booster 
shots.
     Platform for Future Vaccine Development: The stabilization 
techniques used in this technology could be applied to other vaccine 
formulations, paving the way for more robust and effective vaccines 
against various pathogens.
    Competitive Advantages:
     Provides enhanced stability and efficacy in norovirus VLP 
vaccines, ensuring effectiveness even in individuals with strong immune 
responses who have previously shown limited vaccine response.
     Its innovative design increases the VLPs' resistance to 
degradation, offering a more durable and reliable option for large-
scale immunization programs.
    Development Stage:
     Pre-Clinical.
    Inventors: Lisa Lindesmith, Ralph Baric, George Georgiou, Peter 
Kwong, Raffaello Veradi, Yaroslav Tsybovsky, Jason Gorman, Gwo-Yu 
Chuang and Li Ou, all of NIAID.
    Publications: Lu, Yuan et al. ``Assessing sequence plasticity of a 
virus-like nanoparticle by evolution toward a versatile scaffold for 
vaccines and drug delivery.'' Proceedings of the National Academy of 
Sciences of the United States of America vol. 112,40 (2015): 12360-5. 
DOI: 10.1073/pnas.1510533112 at https://doi.org/10.1073/pnas.1510533112; Porta, Claudine et al. ``Rational engineering of 
recombinant picornavirus capsids to produce safe, protective vaccine 
antigen.'' PLoS pathogens vol. 9,3 (2013): e1003255. DOI: 10.1371/
journal.ppat.1003255 at https://doi.org/10.1371/journal.ppat.1003255; 
Mateo, Roberto et al. ``Engineering viable foot-and-mouth disease 
viruses with increased thermostability as a step in the development of 
improved vaccines.'' Journal of virology vol. 82,24 (2008): 12232-40. 
DOI: 10.1128/JVI.01553-08 at https://doi.org/10.1128/jvi.01553-08; 
Bertolotti-Ciarlet, Andrea et al. ``Structural requirements for the 
assembly of Norwalk virus-like particles.'' Journal of virology vol. 
76,8 (2002): 4044-55. DOI: 10.1128/jvi.76.8.4044-4055.2002 at https://doi.org/10.1128/jvi.76.8.4044-4055.2002; Prasad, B V et al. ``X-ray 
crystallographic structure of the Norwalk virus capsid.'' Science (New 
York, N.Y.) vol. 286,5438 (1999): 287-90. DOI: 10.1126/
science.286.5438.287 at https://doi.org/10.1126/science.286.5438.287.
    Intellectual Property: HHS Reference No. E-178-2019-0; U.S. 
Provisional Patent Application No. 63/091,824, filed on October 14, 
2020; PCT Patent Application No. PCT/US2021/55018, filed October 14, 
2021; U.S. National Stage patent application, U.S. 18/031,602, filed 
April 12, 2023.
    Licensing Contact: To license this technology, please contact Brian 
Bailey, Ph.D.; 240-669-5128 or 301-201-9217; [email protected], and 
reference E-178-2019.
    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 technology. For collaboration 
opportunities, please contact Brian Bailey, Ph.D.; 240-669-5128 or 301-
201-9217; [email protected].

    Dated: December 5, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-27112 Filed 12-8-23; 8:45 am]
BILLING CODE 4140-01-P