Lynch syndrome, or Lynch disease, is a rare genetic disorder that puts people at a higher risk for the development of colorectal cancer (CRC) some 20 years before the average age of diagnosis. This hereditary cancer syndrome also increases the risk of developing multiple types of other cancers, including ovarian, uterine, breast, and gastrointestinal cancers. Cancers such as CRC often display distinctive biomarkers, including carcinoembryonic antigen (CEA), mucin-1 (MUC1), and brachyury, that can be used as targets for vaccine-based therapy.
ImmunityBio is committed to finding better treatments for cancer with immunotherapies that have the potential to outsmart the disease. As part of that work, ImmunityBio is developing investigational immunotherapy products designed to help treat cancers such as those resulting from Lynch syndrome, and possibly even developing vaccines to prevent cancer from developing.
The National Cancer Institute (NCI) has opened a Lynch syndrome clinical trial to study ImmunityBio’s investigational Tri-Ad5 vaccine combination (hAd5 CEA/MUC1/brachyury) together with its IL-15 superagonist and immune enhancer N-803 in people with Lynch syndrome. This Phase 2b trial (NCT05419011) will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants who have Lynch syndrome.
For the past decade we have pursued the vision of developing a vaccine that not only treats patients afflicted with cancer, but also has the potential to prevent cancer from developing in the first place. Our Tri-Ad5 vaccine candidate combined with our IL-15 superagonist N-803 has the potential to activate NK cells and T cells to prevent the formation of cancerous cells in subjects with Lynch syndrome. We are excited to partner with the NCI and major academic centers in the country to test this hypothesis in an important Phase 2 study.