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###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, HHS.

# ACTION:

Notice.

# 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:                         *suna.gulay@nih.gov*                         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:*
    - Treatment of SARS-CoV-2 and SARS-CoV-1 infections
    - Preventive of SARS-CoV-2 and SARS-CoV-1 infections and symptoms
    - Therapeutic and preventive use against other coronaviruses and respiratory viruses where the allosteric site of inhibition is conserved.

*Competitive Advantages:*
    - Previously developed corticosteroid with a good safety profile
    - Non-toxic and non-immunosuppressive
    - Nasal delivery
    - Potential use against other coronaviruses
    - 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.                
      ( print page 84611)    

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