[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25003-25004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08642]


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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: 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 by contacting Dr. Benjamin Hurley at 
240-669-5092 or [email protected]. A signed Confidential 
Disclosure Agreement will be required to receive copies of unpublished 
information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Engineered Cell-Penetrating Monoclonal Antibody for Universal Influenza 
Immunotherapy

    Description of Technology:
    Influenza remains a burden on public health, as current treatments 
of viral infections remain ineffective due to frequent virus mutations. 
Many current influenza treatments rely on targeting surface viral 
glycoproteins. Unfortunately, these glycoproteins are primary targets 
of the immune system, which results in increased selection

[[Page 25004]]

pressure and mutational rate, leading to the well-known seasonal 
variation of influenza virus. In contrast, the nucleocapsid viral 
protein (NP), located in the interior of the virus, is more conserved 
and an ideal antibody target; however, NP is inaccessible to 
extracellular antibodies produced in response to infection. To 
circumvent the challenge of targeting NP, scientists at NIAID have 
developed an antibody genetically fused with a cell penetrating peptide 
(CPP-mAb) that targets NP within infected cells to effectively inhibit 
viral replication. By targeting NP rather than the surface 
glycoproteins, this CPP-mAb can treat more influenza variants, 
potentially across flu seasons, and is an improvement upon current 
influenza treatments.
    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:
     Clinical Treatment: CPP-mAbs against influenza NP may be a 
reliable and effective method to treat patients infected with varying 
subtypes of influenza, by targeting a functionally conserved protein.
     CPP-mAbs could be a viable alternative to the treatment of 
influenza when other treatments are ineffective, potentially lowering 
the mortality and morbidity rates in populations susceptible to 
influenza infection.
    Competitive Advantages:
     Current vaccines remain effective for a short time period, 
due to the ever-changing nature of the viral surface glycoproteins. 
CPP-mAbs could remain effective for a longer time period by targeting 
the interior NP of influenza, which is more conserved across influenza 
subtypes.
     Other attempts to produce vaccines against conserved 
portions of the surface viral glycoproteins have failed to produce a 
robust and reliable vaccine. CPP-mAbs could be a more reliable 
therapeutic agent compared to alternatives, potentially effective 
across flu seasons.
     In vivo efficacy: CPP-mAbs against NP increase 
survivorship in mice infected with mouse Influenza A virus, 
demonstrating therapeutic protection.
    Development Stage:
     Pre-Clinical.
    Inventors: Jonathon Yewdell, MD, Ph.D. and Ivan Kosik, Ph.D., both 
from NIAID.
    Publications: Publication pending.
    Intellectual Property: HHS Reference No. E-193-2021; US Provisional 
Application No. 63/365,841, filed on June 3rd, 2022.
    Licensing Contact: To license this technology, please contact 
Benjamin Hurley at 240-669-5092 or [email protected], and 
reference E-193-2021.
    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. For collaboration 
opportunities, please contact Benjamin Hurley; 240-669-5092, 
[email protected].

    Dated: April 19, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-08642 Filed 4-24-23; 8:45 am]
BILLING CODE 4140-01-P