Government Owned Inventions, 89461-89462 [2023-28481]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Bethesda, MD 20892, 301– 496–8683, shimk@nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Chemical Senses Fellowship Review. Date: February 8, 2024. Time: 11:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301–496–8683, yangshi@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Voice Speech and Language Fellowship Review. Date: February 9, 2024. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Sonia Elena Nanescu, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Suite 8300, Bethesda, MD 20892, (301) 496–8683, sonia.nanescu@ nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Hearing and Balance Fellowship Review. Date: February 13, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, 6001 Executive Blvd., Rockville, MD 20852, 301– 402–3587. rayk@nidcd.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: December 21, 2023. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–28572 Filed 12–26–23; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 19:00 Dec 26, 2023 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings 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: Risk, Prevention and Health Behavior Integrated Review Group; Biobehavioral Medicine and Health Outcomes Study Section. Date: January 29–30, 2024. Time: 9:00 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: Mark A. Vosvick, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, Bethesda, MD 20892, (301) 402–4128, mark.vosvick@nih.gov. Name of Committee: Cell Biology Integrated Review Group; Cellular Signaling and Regulatory Systems Study Section. Date: January 29–30, 2024. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: David Balasundaram, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5189, MSC 7840, Bethesda, MD 20892, 301–435– 1022, balasundaramd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–OD– 23–051 Emergency Award: RADx-UP Dissemination and Implementation (D&I) Research on COVID–19 Testing Interventions among Underserved and Vulnerable Populations. Date: January 31, 2024. Time: 10:00 a.m. to 6:00 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: Jessica Bellinger, Ph.D., Scientific Review Administrator, Center for PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 89461 Scientific of Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, Bethesda, MD 20892, 301–827–4446, bellingerjd@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: December 21, 2023. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–28531 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 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is directed to a T cell receptor (TCR) that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 (KK–LC–1). This TCR may be used to develop novel immunotherapies against several common and aggressive epithelial cancers. It may also be possible to use portions of the KK–LC–1 TCR in chimeric proteins for cancer therapy and/or for antigen detection assays. This technology was discovered and is being developed by the National Cancer Institute (NCI). The NCI is currently seeking a licensee and/or collaborator to further develop this technology. FOR FURTHER INFORMATION CONTACT: Inquiries related to this licensing and collaboration opportunity should be directed to: Suna Gulay French, Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702; Telephone: (240) 276–5530; Facsimile: (240) 276–5504; Email: suna.gulay@nih.gov. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to this invention. SUPPLEMENTARY INFORMATION: The following patent applications are available for licensing and/or collaboration under a Cooperative Research and Development Agreement (CRADA): 1. U.S. Provisional Application No. 62/327,529; SUMMARY: E:\FR\FM\27DEN1.SGM 27DEN1 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

Agencies

[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89461-89462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28481]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government Owned Inventions

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: The invention listed below is directed to a T cell receptor 
(TCR) that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 
(KK-LC-1). This TCR may be used to develop novel immunotherapies 
against several common and aggressive epithelial cancers. It may also 
be possible to use portions of the KK-LC-1 TCR in chimeric proteins for 
cancer therapy and/or for antigen detection assays. This technology was 
discovered and is being developed by the National Cancer Institute 
(NCI). The NCI is currently seeking a licensee and/or collaborator to 
further develop this technology.

FOR FURTHER INFORMATION CONTACT: Inquiries related to this licensing 
and collaboration opportunity should be directed to: Suna Gulay French, 
Technology Transfer Manager, NCI Technology Transfer Center, 9609 
Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for 
business mail), Rockville, MD 20850-9702; Telephone: (240) 276-5530; 
Facsimile: (240) 276-5504; Email: [email protected]. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to this invention.

SUPPLEMENTARY INFORMATION: The following patent applications are 
available for licensing and/or collaboration under a Cooperative 
Research and Development Agreement (CRADA):
    1. U.S. Provisional Application No. 62/327,529;

[[Page 89462]]

    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 T-cell 
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 TCR-based 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 life-essential 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.

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-specific and would not damage life-essential 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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.