Government Owned Inventions Available for Licensing/Collaboration: Tixocortol for the Prevention or Treatment of SARS-CoV-2 and Other Coronaviruses, 84610-84611 [2024-24565]

Download as PDF 84610 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 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. 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. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:48 Oct 22, 2024 Jkt 265001 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 SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 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 nonimmunosuppressive • 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. E:\FR\FM\23OCN1.SGM 23OCN1 84611 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices Tixocortol Pivala:~g Potentially repurpoJ~d forSARS-Co OH e 0 H HOH O S-S ~ O .C HI l H . -'"+~ Tixocortol Pivalate Prodrug Dated: October 18, 2024. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant 18:48 Oct 22, 2024 Jkt 265001 0 Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Interaction between ARVs and Hormones in HIV and Coinfections (R01 Clinical Trial Optional). Date: November 19, 2024. Time: 10:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G34, Rockville, MD 20892 (Video Assisted Meeting). Contact Person: Vishakha Sharma, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G34, Rockville, MD 20892, 301–761–7036, vishakha.sharma@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) PO 00000 Frm 00091 Fmt 4703 Tixocortol dfsulphide Tixocortol applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. [FR Doc. 2024–24565 Filed 10–22–24; 8:45 am] VerDate Sep<11>2014 0 Sfmt 4703 i I•, o Dated: October 18, 2024. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–24542 Filed 10–22–24; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration [Docket No. TSA–2018–0001] Surface Transportation Security Advisory Committee; Meeting Transportation Security Administration, Department of Homeland Security. ACTION: Committee management; Notice of open Federal advisory committee meeting. AGENCY: The Transportation Security Administration (TSA) will hold a meeting of the Surface Transportation Security Advisory Committee (STSAC) on November 21, 2024. Members of the public will be able to participate virtually via Microsoft Teams. The SUMMARY: E:\FR\FM\23OCN1.SGM 23OCN1 EN23OC24.006</GPH> HS SARS-COV•2

Agencies

[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.

-----------------------------------------------------------------------

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: [email protected] 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.

[[Page 84611]]

[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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