Government-Owned Inventions; Availability for Licensing, 89462-89463 [2023-28474]

Download as PDF 89462 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices 2. PCT Application No. PCT/US17/ 027865; 3. U.S. Patent No. 11,352,410; 4. Australia Patent Application No. 2017258745; 5. Canada Patent Application No. 3021898; and 6. European Patent No. 17733120.4, validated in Switzerland, Germany, Belgium, Denmark, Spain, Finland, France, United Kingdom, Ireland, Italy, The Netherlands, Norway, Sweden. Achieving expeditious commercialization of federally funded research and development is consistent with the goals of the Bayh-Dole Act, codified as 35 U.S.C. 200–212. Background and Description of Technology Metastatic cancers are the cause of up to 90% of cancer deaths, yet few treatment options exist for patients with metastatic disease. Adoptive transfer of T cells that express tumor-reactive Tcell receptors (TCRs) has been shown to mediate regression of metastatic cancers in some patients. However, identification of antigens that are expressed solely by cancer cells and not normal tissues has been a major challenge for the development of TCRbased immunotherapies. Researchers at the National Cancer Institute (NCI) have developed a TCR that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 (KK–LC–1) 52–60 epitope. KK–LC–1 antigen (encoded by the CT83 gene) is highly expressed in several common and aggressive epithelial tumor types. Importantly, KK–LC–1 is expressed at very low levels in normal tissues and is not expressed in lifeessential tissues. This expression profile makes KK–LC–1 an attractive target for TCR-based anti-cancer therapies. This TCR may be used to genetically modify peripheral blood lymphocytes from eligible patients. After expansion, these genetically modified lymphocytes can be used to treat patients. This technology is currently being evaluated in clinical trials at the NCI and at Rutgers Cancer Institute of New Jersey. ddrumheller on DSK120RN23PROD with NOTICES1 Potential Commercial Applications T cell receptor (TCR)-based immunotherapies and/or therapeutic products against several common and aggressive epithelial tumor types. Competitive Advantages —This TCR has been preclinically validated and is currently being evaluated in the clinic; —Differential expression profile of KK– LC–1 in cancers versus normal tissues suggests that therapy with a specific KK–LC–1 TCR would be cancer- VerDate Sep<11>2014 19:00 Dec 26, 2023 Jkt 262001 specific and would not damage lifeessential tissues; —Thousands of cancer patients each year with otherwise untreatable disease may be eligible for treatment with this TCR. Development Stage Clinical development. Dated: December 20, 2023. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2023–28481 Filed 12–26–23; 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: Brian Bailey at 301–201–9217, 240– 669–5128, or bbailey@mail.nih.gov. Licensing information may be obtained by communicating with 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 information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: Immortalized Rhesus macaque Bcl-6/ Bcl-xL Stable B Cell Lines as Tools for HIV Antibody Discovery. SUMMARY: Description of Technology Scientists at NIAID have developed two immortalized stable B cell lines from rhesus macaques that can have value as research tools for the discovery of neutralizing antibodies of simian origin against HIV and that may have value in the development of an HIV vaccine. These B cell lines encode human Bcl-6 and Bcl-xL proteins, which PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 are major regulators of apoptosis. These B cell lines are derived from the lymph node of a rhesus macaque (RM) that was infected with SHIV.CH505. It was discovered that, unlike in humans, rhesus macaque B cells from lymph nodes are more effectively immortalized than B cells from Peripheral Blood Mononuclear Cells (PBMCs). After sample collection and cryopreservation, pro B cells were isolated, sorted by flow cytometry for populations of interest, then activated with CD40 ligand and RM IL–2 followed by transduction with a retroviral vector encoding Bcl-6, Bcl-xL, and green fluorescent protein (GFL), thereby creating immortalized clonal lines. Two clones were down selected for their in vitro neutralizing ability against HIV pseudovirus CH505. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. Potential Commercial Applications • Bcl-6 and Bc-xL immortalization is a valuable and flexible tool for HIV antibody discovery in rhesus macaques. • Contributes to pre-clinical therapeutic and vaccine development. Competitive Advantages • The cell lines have been characterized and are readily expandable for bulk applications as well as for making high-throughput clonal cultures with or without antigen probes in 384-well plates. Development Stage • Research Materials Inventors: Jakob Samsel, Ph.D.; Richard Koup, MD; Kristin Boswell, Ph.D.; all of NIAID. Publications: Samsel, Jakob, et al. ‘‘Rhesus macaque bcl-6/bcl-XL B cell immortalization: Discovery of HIV–1 neutralizing antibodies from lymph node.’’ Journal of Immunological Methods, vol. 516, May 2023, p. 113445, https://doi.org/10.1016/ j.jim.2023.113445. Intellectual Property: HHS Reference No. E–196–2023–0–EIR–00. Licensing Contact: To license this technology, please contact Brian Bailey at 301–201–9217, 240–669–5128, or bbailey@mail.nih.gov., and reference E– 196–2023. E:\FR\FM\27DEN1.SGM 27DEN1 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices Dated: December 20, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–28474 Filed 12–26–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meetings ddrumheller on DSK120RN23PROD with NOTICES1 Pursuant to section 1009 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: National Institute on Drug Abuse Special Emphasis Panel; JCOIN Methodology Center (MAARC) and JCOIN Coordination Center (CTC). Date: February 16, 2024. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Soyoun Cho, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC, 6021 Bethesda, MD 20892, (301) 594–9460, Soyoun.cho@nih.gov. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; NIDA Research Center of Excellence Grant Program and NIDA Core ‘‘Center of Excellence’’ Grant Program. Date: February 26–27, 2024. Time: 11:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Soyoun Cho, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC, 6021 Bethesda, MD 20892, (301) 594–9460, Soyoun.cho@nih.gov. VerDate Sep<11>2014 19:00 Dec 26, 2023 Jkt 262001 Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Research at Minority Serving Institutions on Neurocognitive Mechanisms Underlying the Impact of Structural Racism on the Substance Use Trajectory. Date: March 14, 2024. Time: 1:30 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Shareen Amina Iqbal, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC, 6021 Bethesda, MD 20892, (301) 443–4577, shareen.iqbal@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug Abuse Scientist Development Award for Clinicians, Scientist Development Awards, and Research Scientist Awards; 93.278, Drug Abuse National Research Service Awards for Research Training; 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: December 21, 2023. Lauren A. Fleck, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–28574 Filed 12–26–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Advisory Child Health and Human Development Council Stillbirth Working Group Meeting AGENCY: National Institutes of Health, HHS. ACTION: Notice. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Stillbirth Working Group of Council is charged with identifying current knowledge on stillbirth and prevention, areas of improvement for data collection, current resources for families impacted by stillbirth, and next steps to gather data and lower the rate of stillbirth in the United States. DATES: The Virtual Meeting will be held on January 24, 2024, from 9 a.m. to 3:30 p.m. EST. ADDRESSES: The meeting will be open to the public. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The session will be Frm 00102 Fmt 4703 videocast and can be accessed from the NIH Videocasting website (https:// videocast.nih.gov/). FOR FURTHER INFORMATION CONTACT: For information concerning this meeting, Dr. Natasha H. Williams, Branch Chief, Office of Legislation and Public Policy NICHD, NIH, 6710B Rockledge Drive, Bethesda, MD 20892–7510, natasha.williams2@nih.gov, (240) 551– 4985. This notice is pursuant to 42 U.S.C. 285g. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nichd.nih.gov/about/advisory, where an agenda and any additional information for the meeting will be posted when available. SUPPLEMENTARY INFORMATION: (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS). Alison N. Cernich, Deputy Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. [FR Doc. 2023–28444 Filed 12–26–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health SUMMARY: PO 00000 89463 Sfmt 4703 National Center for Advancing Translational Sciences; 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 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89462-89463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28474]


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

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: Brian Bailey at 301-201-9217, 240-669-
5128, or [email protected]. Licensing information may be obtained by 
communicating with 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 information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows: Immortalized 
Rhesus macaque Bcl-6/Bcl-xL Stable B Cell Lines as Tools for HIV 
Antibody Discovery.

Description of Technology

    Scientists at NIAID have developed two immortalized stable B cell 
lines from rhesus macaques that can have value as research tools for 
the discovery of neutralizing antibodies of simian origin against HIV 
and that may have value in the development of an HIV vaccine. These B 
cell lines encode human Bcl-6 and Bcl-xL proteins, which are major 
regulators of apoptosis. These B cell lines are derived from the lymph 
node of a rhesus macaque (RM) that was infected with SHIV.CH505. It was 
discovered that, unlike in humans, rhesus macaque B cells from lymph 
nodes are more effectively immortalized than B cells from Peripheral 
Blood Mononuclear Cells (PBMCs).
    After sample collection and cryopreservation, pro B cells were 
isolated, sorted by flow cytometry for populations of interest, then 
activated with CD40 ligand and RM IL-2 followed by transduction with a 
retroviral vector encoding Bcl-6, Bcl-xL, and green fluorescent protein 
(GFL), thereby creating immortalized clonal lines. Two clones were down 
selected for their in vitro neutralizing ability against HIV 
pseudovirus CH505.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

     Bcl-6 and Bc-xL immortalization is a valuable and flexible 
tool for HIV antibody discovery in rhesus macaques.
     Contributes to pre-clinical therapeutic and vaccine 
development.

Competitive Advantages

     The cell lines have been characterized and are readily 
expandable for bulk applications as well as for making high-throughput 
clonal cultures with or without antigen probes in 384-well plates.

Development Stage

     Research Materials
    Inventors: Jakob Samsel, Ph.D.; Richard Koup, MD; Kristin Boswell, 
Ph.D.; all of NIAID.
    Publications: Samsel, Jakob, et al. ``Rhesus macaque bcl-6/bcl-XL B 
cell immortalization: Discovery of HIV-1 neutralizing antibodies from 
lymph node.'' Journal of Immunological Methods, vol. 516, May 2023, p. 
113445, https://doi.org/10.1016/j.jim.2023.113445.
    Intellectual Property: HHS Reference No. E-196-2023-0-EIR-00.
    Licensing Contact: To license this technology, please contact Brian 
Bailey at 301-201-9217, 240-669-5128, or [email protected]., and 
reference E-196-2023.


[[Page 89463]]


    Dated: December 20, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-28474 Filed 12-26-23; 8:45 am]
BILLING CODE 4140-01-P
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