Notice2024-19719
Government-Owned Inventions; Availability for Licensing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 4, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 171 (Wednesday, September 4, 2024)</title>
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[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71912-71913]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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; <a href="/cdn-cgi/l/email-protection#91fcf8f2f9f0f4fdbfe2f9fcf8fdfee7f8f2f9d1fff8f9bff6fee7"><span class="__cf_email__" data-cfemail="bed3d7ddd6dfdbd290cdd6d3d7d2d1c8d7ddd6fed0d7d690d9d1c8">[email protected]</span></a> at the National
Heart, Lung, and Blood, Office of Technology Transfer and Development,
31 Center Drive Room 4A25, MSC2479, Bethesda, MD 20892-2479;
<a href="/cdn-cgi/l/email-protection#692721252b20363d0c0a013d1b08071a0f0c1b290408000547070001470e061f"><span class="__cf_email__" data-cfemail="024c4a4e404b5d5667616a5670636c71646770426f636b6e2c6c6b6a2c656d74">[email protected]</span></a>. 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Agreement may be required to receive any unpublished information.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
<bullet> Imaging of live infections.
Development Stage
<bullet> In vitro data
<bullet> Preclinical in vivo data (mouse models)
Related Publications
<bullet> 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. <a href="https://doi.org/10.3390/molecules28093773">https://doi.org/10.3390/molecules28093773</a>.
<bullet> 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. <a href="https://doi.org/10.1126/scitranslmed.adl5934">https://doi.org/10.1126/scitranslmed.adl5934</a>.
<bullet> 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. <a href="https://doi.org/10.1002/jlcr.4116">https://doi.org/10.1002/jlcr.4116</a>.
Intellectual Property
<bullet> 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).
<bullet> 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
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