[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71912-71913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19719]


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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 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; [email protected] at the National 
Heart, Lung, and Blood, Office of Technology Transfer and Development, 
31 Center Drive Room 4A25, MSC2479, Bethesda, MD 20892-2479; 
[email protected]. 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Agreement may be required to receive any unpublished information.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-

[[Page 71913]]

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
     Preclinical in 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