[Federal Register Volume 89, Number 32 (Thursday, February 15, 2024)]
[Notices]
[Page 11845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03121]


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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 Dawn Taylor-Mulneix at 
301-451-8021 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Disclosure Agreement will be required to receive copies of unpublished 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:

Equipping Natural Killer Cells With a CD28H-Containing Chimeric Antigen 
Receptor To Overcome Inhibition for Cancer Immunotherapy

Description of Technology

    Immunotherapy with chimeric antigen receptor (CAR) cytotoxic T 
cells have been successful in the clinical treatment of hematologic 
cancers; however adverse side effects such as severe cytokine release 
syndrome and neurotoxicity are associated with CAR-T cell infusion. CAR 
natural killer (NK) cells represent a viable alternative with 
demonstrated advantages over CAR-T cells for the elimination of tumor 
cells, but NK inhibitory cell receptors need to be reduced or 
overridden. To overcome this challenge, scientists at NIAID have 
developed CAR constructs that overcome inhibition of NK cells by 
receptors for human major histocompatibility complex molecules HLA-E 
and HLA-C, based on in vitro studies. NK cells that are expressing 
variants of this invention robustly overcome inhibition imposed by 
CD19\+\ HLA-I\+\ tumor cells and are cytotoxic to them.
    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

     Method of adoptive cell therapy where CAR-NK cells are the 
effective cell.

Competitive Advantages

     CD28H CAR-NK cells induce a more robust anti-tumor 
cytotoxic activity compared to third generation CAR-T cells and are 
more potent in overcoming inhibition.
     CAR-NK can be developed without the need of genetic 
silencing of TCR.

Developmental Stage

     Pre-clinical.
    Inventors: Eric Long, Ph.D. and Xiaoxuan Zhuang, both of NIAID.
    Publications:
    Zhuang X., Long E.O., ``NK cells equipped with a chimeric antigen 
receptor that overcomes inhibition by HLA Class I for adoptive transfer 
of CAR-NK Cells. Front. Immunol. 13:840844. https://www.frontiersin.org/articles/10.3389/fimmu.2022.840844/full. May 2, 
2022.
    Zhuang X. and Long E.O., ``CD28 homolog is a strong activator of 
Natural Killer cells for lysis of B7H7-positive tumor cells.'' Cancer 
Immunol. Res. 7(6):939-951. https://cancerimmunolres.aacrjournals.org/content/7/6/939.long. April 24, 2019.
    Zhuang X, Long E.O. ``Inhibition-resistant CARs for NK cell cancer 
immunotherapy.'' Trends Immunol. 40(12):1078-1081.https://
www.sciencedirect.com/science/article/pii/S1471490619302133?via%3Dihub. 
November 12, 2019.
    Intellectual Property: HHS Reference No. E-097-2020; Patent 
Application Nos.: PCT Application No. PCT/US2020/02498, US: 17/914,027, 
Australia: 2020437669, Brazil: BR112022017512-4, Canada: 3174779, 
Europe: 20719313.7, India: 2022170585054, Japan: 2022-557764, South 
Korea: 10-2022-7037236.
    Licensing Contact: To license this technology, please contact Dawn 
Taylor-Mulneix at 301-451-8021 or [email protected], and 
reference E-097-2020.
    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 Dawn Taylor-Mulneix at 301-451-8021 or 
[email protected].

    Dated: February 9, 2024.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2024-03121 Filed 2-14-24; 8:45 am]
BILLING CODE 4140-01-P