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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 [www.gpo.gov]
[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: [email protected] 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:
     Companion diagnostic for cellular immunotherapies.
     Companion diagnostic for monitoring the effectiveness of 
TCR-based immunotherapies.
     Companion diagnostic for T cell-based 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.

Competitive Advantages

     First method to predict response to immunotherapies by 
detecting damaging mutations using liquid biopsy samples.
     Non-invasive test not requiring surgery.
     Easy to administer.
     Allows patient-tailored treatment and monitor the 
effectiveness of TCR-based 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
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