Notice2024-26446
Government Owned Inventions Available for Licensing or Collaboration: Methods of Detecting Loss of Heterozygosity and Damaging Mutations in Immune-Related Genes Using Liquid Biopsies
Primary source
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Published
November 14, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 220 (Thursday, November 14, 2024)</title>
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[Federal Register Volume 89, Number 220 (Thursday, November 14, 2024)]
[Notices]
[Page 90020]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-26446]
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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.
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SUMMARY: 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: <a href="/cdn-cgi/l/email-protection#5b282e353a753c2e373a221b353233753c342d"><span class="__cf_email__" data-cfemail="3241475c531c55475e534b725c5b5a1c555d44">[email protected]</span></a> 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-[gamma] (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 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 non-invasive 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 co-development 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:
<bullet> Companion diagnostic for cellular immunotherapies.
<bullet> Companion diagnostic for monitoring the effectiveness of
TCR-based immunotherapies.
<bullet> Companion diagnostic for T cell-based immunotherapies,
including certain immune checkpoint inhibitors.
<bullet> Research use in labs studying and developing new pre-
clinical therapeutic candidates.
<bullet> 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.
Competitive Advantages
<bullet> First method to predict response to immunotherapies by
detecting damaging mutations using liquid biopsy samples.
<bullet> Non-invasive test not requiring surgery.
<bullet> Easy to administer.
<bullet> Allows patient-tailored treatment and monitor the
effectiveness of TCR-based immunotherapies in a simple and cost-
effective manner.
<bullet> Potential improvement in patient survival.
<bullet> 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
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