# Government-Owned Inventions; Availability for Licensing
**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; *[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Bethesda, MD 20892-2479; *[email protected].* A signed Confidential Disclosure Agreement may be required to receive any unpublished information.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, <sup>18</sup> 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*
• 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.