National Center for Complementary & Integrative Health; Amended Notice of Meeting, 90020 [2024-26527]
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90020
Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices
Patent Status: PCT Application PCT/
US2023/085725 filed on December 22,
2023.
Development Stage: Clinical Phase I.
Dated: November 8, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–26451 Filed 11–13–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government Owned Inventions
Available for Licensing or
Collaboration: Methods of Detecting
Loss of Heterozygosity and Damaging
Mutations in Immune-Related Genes
Using Liquid Biopsies
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 or
collaboration opportunities for the
inventions listed below, which are
owned by an agency of the U.S.
Government and are available for
licensing or collaboration to achieve
expeditious commercialization of
results of federally funded research and
development.
FOR FURTHER INFORMATION CONTACT:
Inquiries related to these licensing and
collaboration opportunities 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.
SUPPLEMENTARY INFORMATION: The
technology is a liquid biopsy diagnostic
assay capable of detecting loss of
heterozygosity (LOH) and somatic
mutations in genes important for
antigen processing and presentation and
interferon-g (IFN) response pathways.
Immunotherapy is an effective cancer
treatment utilizing T cells to recognize
and eliminate cancer cells. Antigen
processing and presentation machinery
(APM) and IFN response pathways play
an important role for T cells to target
cancer cells. To evade immunotherapy,
cancer cells can develop somatic
mutations in genes important for APM
and IFN.
Liquid biopsy is a non-invasive tool
that can diagnose and monitor cancer by
analyzing circulating tumor DNA. The
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ability to detect somatic mutations and
predict response to immunotherapies
using liquid biopsy would be critical to
provide more personalized cancer
treatment. However, currently marketed
liquid biopsies cannot predict response
to cellular immunotherapies. As a
result, patients with relapsed or
recurrent disease lose valuable time and
resources on ineffective treatments.
The inventors at the NCI developed a
novel method to detect somatic
mutations from liquid biopsy samples.
Combined with NCI’s method to detect
loss of heterozygosity in HLA genes—
another mechanism for immunotherapy
evasion—this invention allows for
improved patient selection and noninvasive prediction of response. This
novel precision medicine method will
allow patient-tailored treatment by
targeting treatment based on genetic
mutations and prediction of
immunotherapy response. This
invention could potentially deliver
better patient satisfaction, lower
healthcare costs and better outcomes.
This invention will be used to select
optimal patients and monitor efficacy of
treatments—such as TCR–T cell
therapy. There are no liquid biopsy
assays on the market designed as
companion diagnostics for cellular
immunotherapy—such as TCR–T cell
therapy. Therefore, this technology may
be particularly appealing to codevelopment partners who are
developing proprietary cellular
immunotherapies.
This Notice is in accordance with 35
U.S.C. 209 and 37 CFR part 404.
NIH Reference Number: E–027–2024–
0.
Related Technologies: E–045–2022–0.
Product Type: Diagnostic.
Therapeutic Area(s): Oncology or
Immunology.
Potential Commercial Applications:
• Companion diagnostic for cellular
immunotherapies.
• Companion diagnostic for
monitoring the effectiveness of TCRbased immunotherapies.
• Companion diagnostic for T cellbased immunotherapies, including
certain immune checkpoint inhibitors.
• Research use in labs studying and
developing new pre-clinical therapeutic
candidates.
• Research use in basic research labs
studying immunotherapy resistance
mechanisms, antigen processing and
presentation, IFN response pathways,
mutations in cancer cells, basic
immunology and basic oncology.
damaging mutations using liquid biopsy
samples.
• Non-invasive test not requiring
surgery.
• Easy to administer.
• Allows patient-tailored treatment
and monitor the effectiveness of TCRbased immunotherapies in a simple and
cost-effective manner.
• Potential improvement in patient
survival.
• Potential time and money savings
for patients, physicians and hospitals.
Patent Status: US Provisional
Application 63/572,760 filed on April 4,
2024.
Development Stage: Prototype.
Dated: November 8, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–26446 Filed 11–13–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Council for Complementary and
Integrative Health, January 24, 2025,
10:00 a.m. to January 24, 2025, 4:00
p.m., National Institutes of Health, DEM
2, 6707 Democracy Boulevard,
Bethesda, MD, 20892 which was
published in the Federal Register on
September 25, 2024, 89 FR 78318.
The notice is being amended to
change the start and end times of the
open session portion of the meeting.
The open session start time has changed
from 12:30 p.m. to 1:00 p.m. and the
end time has changed from 4:00 p.m. to
5:00 p.m. This meeting is partially
closed to the public.
Dated: November 8, 2024.
David W Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–26527 Filed 11–13–24; 8:45 am]
BILLING CODE 4140–01–P
Competitive Advantages
• First method to predict response to
immunotherapies by detecting
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Agencies
[Federal Register Volume 89, Number 220 (Thursday, November 14, 2024)]
[Notices]
[Page 90020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26527]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary & Integrative Health; Amended
Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Advisory Council for Complementary and Integrative Health, January 24,
2025, 10:00 a.m. to January 24, 2025, 4:00 p.m., National Institutes of
Health, DEM 2, 6707 Democracy Boulevard, Bethesda, MD, 20892 which was
published in the Federal Register on September 25, 2024, 89 FR 78318.
The notice is being amended to change the start and end times of
the open session portion of the meeting. The open session start time
has changed from 12:30 p.m. to 1:00 p.m. and the end time has changed
from 4:00 p.m. to 5:00 p.m. This meeting is partially closed to the
public.
Dated: November 8, 2024.
David W Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2024-26527 Filed 11-13-24; 8:45 am]
BILLING CODE 4140-01-P