Government-Owned Inventions; Availability for Licensing, 4833-4834 [2023-01418]

Download as PDF Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Notices biomedical, biodefense, or health industries; faculty or researchers at academic institutions; health professionals, health system experts, or those who work in health care consumer organizations; or experts in state, Tribal, territorial, or local government agencies. Requests to provide remarks to the NBSB during the public meeting must be sent to NBSB@hhs.gov by March 2, 2023. In that request, please provide the speaker’s name, title, position, and organization, with a brief description of the topic that they will address. Requests to speak to the Board will be approved in consultation with the Board Chair and based on time available during the meeting. FOR FURTHER INFORMATION CONTACT: CAPT Christopher Perdue, NBSB Designated Federal Official, (202) 480– 7226, NBSB@hhs.gov. Dawn O’Connell, Assistant Secretary for Preparedness and Response. [FR Doc. 2023–01460 Filed 1–24–23; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Amy F. Petrik, Ph.D., 240–627–3721; amy.petrik@nih.gov. Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows: lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 16:55 Jan 24, 2023 Jkt 259001 Antibodies With Potent and Broad Neutralizing Activity Against Antigenically Diverse and Highly Transmissible SARS–CoV–2 Variants Description of Technology: Emergence of highly transmissible SARS–CoV–2 variants of concern that are resistant to current therapeutic antibodies highlights the need for continuing discovery of broadly reactive antibodies. Scientists at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases have identified multiple antibodies that ultrapotently neutralize SARS–CoV–2, including the highly transmissible BA.4, BA.5, BQ.1.1 and XBB subvariants of Omicron, as shown in a pseudovirus neutralization assay. These antibodies target several epitopes in the receptor binding domain of the spike protein that are not impacted by spike mutations that knockout binding to other therapeutic antibodies, including, K417N, N439K, N440K, K444T, V445P, G446S, L452R, Y453F, N460K, S477N, E484A/K, F486S/V and Q498R. Several of the antibodies are able to simultaneously bind to the spike protein and are compatible for use in combination therapies. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Potential Commercial Applications: • Treatment of SARS–CoV–2 infection Competitive Advantages: • Ultra-potent neutralization of currently identified SARS–CoV–2 variants including Omicron subvariants BQ.1.1 and XBB • Mechanism of Action—Some antibodies directly bind to and block ACE2 receptor binding to the SARS– CoV–2 spike protein Development Stage: Preclinical Research. Inventors: John Misasi (VRC, NIAID), Lingshu Wang (VRC, NIAID), John Mascola (VRC, NIAID), Daniel Douek (VRC, NIAID), Nancy Sullivan (VRC, NIAID), Richard Alan Koup (VRC, NIAID), Man Chen, (VRC, NIAID), Wei Shi (VRC, NIAID), Yi Zhang (VRC, NIAID), Eun Sung Yang (VRC, NIAID), Nicole Doria-Rose (VRC, NIAID), Chaim Schramm (VRC, NIAID), Kevina Maria Nabireka Birungi-Huff (VRC, NIAID), Sabrina Bush (VRC, NIAID), Maryam Musayev (VRC, NIAID). Publications: None. Intellectual Property: HHS Reference Number E–024–2023 includes U.S. Provisional Patent Application Number 63/433,719 filed December 19, 2022. Licensing Contact: To license this technology, please contact Amy F. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 4833 Petrik, Ph.D., 240–627–3721; amy.petrik@nih.gov. Dated: January 19, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–01416 Filed 1–24–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Amy F. Petrik, Ph.D., 240–627–3721; amy.petrik@nih.gov. Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows: Antibodies with potent and broad neutralizing activity against antigenically diverse and highly transmissible SARS–CoV–2 variants. Description of Technology: Emergence of highly transmissible SARS–CoV–2 variants of concern that are resistant to current therapeutic antibodies highlights the need for continuing discovery of broadly reactive antibodies. Scientists at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases have engineered a group of human monoclonal antibodies that target epitopes on the receptor binding domain of SARS–CoV–2 spike protein. SUMMARY: E:\FR\FM\25JAN1.SGM 25JAN1 lotter on DSK11XQN23PROD with NOTICES1 4834 Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Notices These engineered antibodies ultrapotently neutralize >12 variants of SARS–CoV–2, including the highly transmissible BA.4 and BA.5 subvariants of Omicron, as shown in a pseudovirus neutralization assay. These engineered antibodies target 3 distinct epitopes in the receptor binding domain of the spike protein and function by blocking ACE2 binding. These engineered antibodies are not impacted by spike mutations that knockout binding to other therapeutic antibodies, including E484K, N439K, Y453F, L452R and K417N. Several of the engineered antibodies are able to simultaneously bind to the spike protein and are compatible for use in combination therapies. In in vitro assays, these combinations were shown to decrease the appearance of escape mutants suggesting the potential to mitigate resistance development when used as combination therapy. Additionally, these engineered antibodies are better suited for manufacturing than the parental antibodies. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Potential Commercial Applications: • Treatment of SARS–CoV–2 infection Competitive Advantages: • Ultra-potent neutralization of currently identified SARS–CoV–2 variants including Omicron subvariants • Combinations show the potential to mitigate resistance • Improved manufacturability relative to parental antibodies • Mechanism of Action—These antibodies bind to block ACE2 receptor binding to the SARS CoV–2 spike protein Development Stage: Preclinical Research. Inventors: John Misasi (VRC, NIAID), Lingshu Wang (VRC, NIAID), John Mascola (VRC, NIAID), Nancy Sullivan (VRC, NIAID), Misook Choe (VRC, NIAID), Richard Alan Koup (VRC, NIAID), Man Chen, (VRC, NIAID), Tongqing Zhou (VRC, NIAID), Peter Kwong (VRC, NIAID), Wei Shi (VRC, NIAID), Yi Zhang (VRC, NIAID), Eun Sung Yang (VRC, NIAID). Publications: None. Intellectual Property: HHS Reference Number E–185–2022 includes U.S. Provisional Patent Application Number 63/404,473 filed September 7, 2022. Licensing Contact: To license this technology, please contact Amy F. Petrik, Ph.D., 240–627–3721; amy.petrik@nih.gov. VerDate Sep<11>2014 19:12 Jan 24, 2023 Jkt 259001 Dated: January 19, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–01418 Filed 1–24–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings 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 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Modeling and Analysis of Biological Systems Study Section. Date: February 21–22, 2023. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Zarana Patel, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 496–9295, zarana.patel@ nih.gov. Name of Committee: Oncology 1—Basic Translational Integrated Review Group; Cancer Genetics Study Section. Date: February 21–22, 2023. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Juraj Bies, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4158, MSC 7806, Bethesda, MD 20892, (301) 435–1256, biesj@mail.nih.gov. Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroscience and Neurodegeneration Study Section. Date: February 22–23, 2023. Time: 8:30 a.m. to 6:00 p.m. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Agenda: To review and evaluate grant applications. Place: The Westin Georgetown, 2350 M Street NW, Washington, DC 20037. Contact Person: Jordan M. Moore, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1002A1, Bethesda, MD 20892, (301) 451–0293, jordan.moore@nih.gov. Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Cardiovascular Differentiation and Development Study Section. Date: February 22, 2023. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sara Ahlgren, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, RM 4136, Bethesda, MD 20892, (301) 435–0904, sara.ahlgren@nih.gov. Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Therapeutic Development and Preclinical Studies Study Section. Date: February 22–23, 2023. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health. Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Richard D. Schneiderman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, Bethesda, MD 20817, 301–402–3995, richard.schneiderman@nih.gov. Name of Committee: Oncology 1—Basic Translational Integrated Review Group; Tumor Host Interactions Study Section. Date: February 22–23, 2023. Time: 9:30 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Angela Y. Ng, Ph.D., MBA, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 710–C, MSC 7806, Bethesda, MD 20892, (301) 435– 1715, nga@csr.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Biobehavioral Mechanisms of Emotion, Stress and Health Study Section. Date: February 22–23, 2023. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Brittany L. Mason-Mah, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1000A, E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4833-4834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01418]


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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.

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

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Amy F. Petrik, Ph.D., 240-627-3721; 
[email protected]. Licensing information and copies of the U.S. patent 
application listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows: Antibodies 
with potent and broad neutralizing activity against antigenically 
diverse and highly transmissible SARS-CoV-2 variants.
    Description of Technology:
    Emergence of highly transmissible SARS-CoV-2 variants of concern 
that are resistant to current therapeutic antibodies highlights the 
need for continuing discovery of broadly reactive antibodies.
    Scientists at the Vaccine Research Center of the National Institute 
of Allergy and Infectious Diseases have engineered a group of human 
monoclonal antibodies that target epitopes on the receptor binding 
domain of SARS-CoV-2 spike protein.

[[Page 4834]]

These engineered antibodies ultra-potently neutralize >12 variants of 
SARS-CoV-2, including the highly transmissible BA.4 and BA.5 
subvariants of Omicron, as shown in a pseudovirus neutralization assay. 
These engineered antibodies target 3 distinct epitopes in the receptor 
binding domain of the spike protein and function by blocking ACE2 
binding. These engineered antibodies are not impacted by spike 
mutations that knockout binding to other therapeutic antibodies, 
including E484K, N439K, Y453F, L452R and K417N. Several of the 
engineered antibodies are able to simultaneously bind to the spike 
protein and are compatible for use in combination therapies. In in 
vitro assays, these combinations were shown to decrease the appearance 
of escape mutants suggesting the potential to mitigate resistance 
development when used as combination therapy. Additionally, these 
engineered antibodies are better suited for manufacturing than the 
parental antibodies.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.
    Potential Commercial Applications:

 Treatment of SARS-CoV-2 infection

    Competitive Advantages:

 Ultra-potent neutralization of currently identified SARS-CoV-2 
variants including Omicron subvariants
 Combinations show the potential to mitigate resistance
 Improved manufacturability relative to parental antibodies
 Mechanism of Action--These antibodies bind to block ACE2 
receptor binding to the SARS CoV-2 spike protein

    Development Stage: Preclinical Research.
    Inventors: John Misasi (VRC, NIAID), Lingshu Wang (VRC, NIAID), 
John Mascola (VRC, NIAID), Nancy Sullivan (VRC, NIAID), Misook Choe 
(VRC, NIAID), Richard Alan Koup (VRC, NIAID), Man Chen, (VRC, NIAID), 
Tongqing Zhou (VRC, NIAID), Peter Kwong (VRC, NIAID), Wei Shi (VRC, 
NIAID), Yi Zhang (VRC, NIAID), Eun Sung Yang (VRC, NIAID).
    Publications: None.
    Intellectual Property: HHS Reference Number E-185-2022 includes 
U.S. Provisional Patent Application Number 63/404,473 filed September 
7, 2022.
    Licensing Contact: To license this technology, please contact Amy 
F. Petrik, Ph.D., 240-627-3721; [email protected].

    Dated: January 19, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-01418 Filed 1-24-23; 8:45 am]
BILLING CODE 4140-01-P

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