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. 

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 cancerspecific 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. 

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 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. 

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 

bbailey@mail.nih.gov., and reference E– 

196–2023. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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: 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. 

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. 

SUMMARY: 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 

videocast and can be accessed from the 

NIH Videocasting website (http://

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. 

SUPPLEMENTARY INFORMATION: 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. 

(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 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1