[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84610-84611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24565]



[[Page 84610]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government Owned Inventions Available for Licensing/
Collaboration: Tixocortol for the Prevention or Treatment of SARS-CoV-2 
and Other Coronaviruses

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute (NCI), an institute of the 
National Institutes of Health (NIH), Department of Health and Human 
Services (HHS), is giving notice of the licensing and collaboration 
opportunity for the inventions listed below, which are owned by an 
agency of the U.S. Government and are available for licensing in the 
U.S. to achieve expeditious commercialization of results of federally-
funded research and development.

FOR FURTHER INFORMATION CONTACT: Inquiries related to this licensing/
collaboration opportunity should be directed to: Suna Gulay French, 
Ph.D., Technology Transfer Manager, NCI, Technology Transfer Center, 
Email: <a href="/cdn-cgi/l/email-protection#added8c3cc83cad8c1ccd4edc3c4c583cac2db"><span class="__cf_email__" data-cfemail="daa9afb4bbf4bdafb6bba39ab4b3b2f4bdb5ac">[email protected]</span></a> or Phone: 240-276-7424.

SUPPLEMENTARY INFORMATION: The recent COVID-19 pandemic led to millions 
of deaths worldwide--presenting an urgent need to develop vaccines and 
therapeutics against SARS-CoV-2 infections. Although vaccines saved 
lives by preventing severe disease progression, there remains a need 
for additional therapeutics that may prevent and/or treat coronavirus 
infections. The return of symptoms after the use of certain COVID-19 
medications demonstrate the need for additional treatment options.
    Investigators at the NCI have found a previously approved 
corticosteroid, tixocortol, to be an inhibitor of the homodimeric main 
protease (Mpro) of SARS-CoV-2 at an allosteric site of inhibition, 
cysteine residue 300 (Cys300). Coronaviruses rely on Mpro for 
proteolytic processing to produce mature forms of the virus--deeming 
Mpro an excellent target to inhibit SARS-CoV-2 infection. Tixocortol 
may also be useful against SARS-CoV-1 due to the conservation of Cys300 
and in future coronavirus outbreaks. Tixocortol displays inhibitory 
effect against Mpro when added to cell culture up to 18 hours prior to 
coronavirus infection, indicating possible preventive use. Tixocortol 
pivalate was previously manufactured as a spray and would be easy to 
apply before entering crowded areas for prevention.
    This Notice is in accordance with 35 U.S.C. 209 and 37 CFR part 
404.
    NIH Reference Number: E-228-2023-0.
    Potential Commercial Applications:

<bullet> Treatment of SARS-CoV-2 and SARS-CoV-1 infections
<bullet> Preventive of SARS-CoV-2 and SARS-CoV-1 infections and 
symptoms
<bullet> Therapeutic and preventive use against other coronaviruses and 
respiratory viruses where the allosteric site of inhibition is 
conserved.

    Competitive Advantages:

<bullet> Previously developed corticosteroid with a good safety profile
<bullet> Non-toxic and non-immunosuppressive
<bullet> Nasal delivery
<bullet> Potential use against other coronaviruses
<bullet> Inhibitory effect against SARS-CoV-2 main protease in cell 
culture up to 18 hours prior to viral infection

    Patent Status: US Provisional Application 65/599,446 filed on 
November 15, 2023.
    Therapeutic Area(s): Infectious Diseases, immune, or inflammation.
    Development Stage: Discovery.

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[GRAPHIC] [TIFF OMITTED] TN23OC24.006


    Dated: October 18, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2024-24565 Filed 10-22-24; 8:45 am]
BILLING CODE 4140-01-P


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