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Government-Owned Inventions; Availability for Licensing

89 Fed. Reg. 71912 (Sep. 4, 2024)

Government-Owned Inventions; Availability for Licensing

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Federal RegisterSep 4, 2024
89 Fed. Reg. 71912 (Sep. 4, 2024)
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    Department of Health and Human Services National Institutes of Health

    AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research for the benefit of the public health.

    FOR FURTHER INFORMATION CONTACT:

    Licensing information may be obtained by emailing the indicated licensing contact Michael Shmilovich, Esq, MS, CLP; 301-435-5019; michael.shmilovich@nih.gov at the National Heart, Lung, and Blood, Office of Technology Transfer and Development, 31 Center Drive Room 4A25, MSC2479, Bethesda, MD 20892-2479; NHLBI_TechTransfer@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.

    SUPPLEMENTARY INFORMATION:

    This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404. Technology description follows.

    PET Imaging Agents for Fungal Infections

    Available for licensing and commercial development are patent rights covering PET imaging agents, methods of their synthesis, and their uses in imaging specific fungal infections. Fungal infections remain a global health problem resulting in over 1.5 million annual deaths. Immunocompromised patients, especially those undergoing cancer treatments or transplantation, are particularly vulnerable and the fungus, Aspergillus fumigatus, is of particular concern. To date, no fungal- specific imaging agents are available—existing imaging agents cannot discern fungal pathogens from bacteria or viruses and generally cannot differentiate between infection and inflammation. One naturally-occurring disaccharide, cellobiose, is selectively hydrolyzed by Aspergillus fumigatus and not by bacteria or human cells. The fluorinated version of the disaccharide,18 F-Fluorodeoxycellobiose ([18F]-FCB), has been synthesized and tested. [18F]-FCB is particularly useful as it is not metabolized by human enzymes and hydrolyzed only by fungal beta- glucosidases. Both in vitro and in vivo testing in animal models (see publications below) of different infections and inflammation confirmed radioactivity accumulation only in live pathogenic fungi. Imaging with [18F]-FCB in mice infected with Aspergillus, for example, showed that the imaging agent can detect whether there has been a response to antifungal therapy. One major advantage is that synthesis of [18F]-FCB is simple and efficient using readily commercially available reagents. The radiolabeled agent can then be administered intravenously, and imaging performed 90-120 minutes after injection. A radiosynthesis kit has also been developed and can be used at ambient temperature to produce [18F]-FCB from a commercially acquired kit in less than two hours without the need for a cyclotron.

    Potential Commercial Applications

    • Imaging of live infections.

    Development Stage

    • In vitro data
    • Preclinicalin vivo data (mouse models)

    Related Publications

    • Zhang X, Basuli F, Shi Z-D, Shah S, Shi J, Mitchell A, Lai J, Wang Z, Hammoud DA, Swenson RE. Synthesis and Evaluation of Fluorine-18-Labeled L-Rhamnose Derivatives. Molecules. 2023; 28(9):3773. https://doi.org/10.3390/molecules28093773.
    • Shah, S., Lai, J., Basuli, F., Martinez-Orengo, N., Patel, R., Turner, M.L., Wang, B., Shi, Z.D., Sourabh, S., Peiravi, M., Lyndaker, A., Liu, S., Seyedmousavi, S., Williamson, P.R., Swenson, R.E., & Hammoud, D.A. (2024). Development and preclinical validation of 2-deoxy 2-[18F]fluorocellobiose as an Aspergillus-specific PET tracer. Science translational medicine, 16(760), eadl5934. https://doi.org/10.1126/scitranslmed.adl5934.
    • Basuli, F., Shi, J., Shah, S., Lai, J., Hammoud, D.A., & Swenson, R.E. (2024). Fully Automated Cassette-Based Synthesis of 2-Deoxy-2-[18F]Fluorocellobiose Using Trasis AllInOne Module. Journal of labelled compounds & radiopharmaceuticals, 67(9), 308-313. https://doi.org/10.1002/jlcr.4116.

    Intellectual Property

    • NIH Reference No. E-163-2019; U.S. Provisional Patent Application 62/882,023 filed August 2, 2019; International Patent Application PCT/US2020/044446 filed July 31, 2020 (published as WIPO publication WO 2021/025984); and national stage patent applications filed in Europe (20757180.3) and the United States (17/631,600).
    • NIH Reference No. E-080-2023; U.S. Provisional Patent Application 63/492,302 filed March 27, 2023, and International Patent Application PCT/US2024/021440 filed March 26, 2024.

    Dated: August 28, 2024.

    Michael A. Shmilovich,

    Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.

    [FR Doc. 2024-19719 Filed 9-3-24; 8:45 am]

    BILLING CODE 4140-01-P