Description:
Summary:
The National Cancer Institute (NCI) seeks co-development partners and/or licensees for 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-γ response pathways.
Description of Technology:
Immunotherapy is an effective treatment of cancer utilizing T cells to recognize and eliminate cancer cells. Antigen processing and presentation machinery (APM) and interferon-γ (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 (ctDNA). The ability to detect somatic mutations and predict response to immunotherapies using liquid biopsy would be critical to provide more personalized treatment to cancer patients. However, liquid biopsies that are currently on the market are not capable of predicting response to cellular immunotherapies, causing patients with relapsed or recurrent disease to waste valuable time and resources on therapies that may not be beneficial in their case.
The inventors at the National Cancer Institute (NCI) developed a novel method to detect somatic mutations from liquid biopsy samples. In combination with NCI’s method to detect loss of heterozygosity in HLA genes (which is another mechanism leading to immunotherapy evasion), this new invention allows for improved patient selection and prediction of response to immunotherapies non-invasively. This novel precision medicine method will allow patient-tailored treatment by altering immunotherapy treatment plans based on genetic mutations and prediction of immunotherapy response. This invention could potentially deliver better patient satisfaction, lower healthcare costs, and lead to better treatment outcomes.
The Center for Immuno-Oncology at the NCI is looking for co-development partners and/or licensees. As a companion diagnostic for immunotherapies, this invention will be used to select optimal patients fitted for specific immunotherapy treatments and monitor the efficacy of immune treatments such as TCR-T cell therapy. As there are no liquid biopsy assays on the market that are being designed as companion diagnostic for cellular immunotherapy such as TCR-T cell therapy, this technology may be particularly appealing to co-development partners who are developing proprietary cellular immunotherapies.
Potential Commercial Applications:
• Companion diagnostic for cellular immunotherapies in experimental clinical trials
• Companion diagnostic for monitoring the effectiveness of TCR-based immunotherapies in FDA-approved clinical practice
• Companion diagnostic for T cell based immunotherapies, including certain immune checkpoint inhibitors
• Research use in labs studying/developing new pre-clinical therapeutic candidates
• Research use in basic research labs studying immunotherapy resistance mechanisms, antigen processing and presentation, interferon-γ response pathways, and basic immunology
• Research use in basic research labs studying mutations in cancer cells 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 and 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, insurance companies, and immunotherapy manufacturers