ImmunityBio, Inc. today announced the opening of a clinical trial to study its investigational Tri-Ad5 vaccine combination and its IL-15 superagonist N-803 for people with a hereditary condition known as Lynch syndrome.
An estimated 1 in every 300 people may be carriers of a mutation in a gene associated with Lynch syndrome.
This Phase 2b clinical trial, sponsored by the National Cancer Institute (NCI), will study whether Tri-Ad5, in combination with N-803, works to prevent colorectal and other cancers in study participants.
Tri-Ad5 vaccines target three tumor-associated antigens: brachyury, carcinoembryonic antigen, and mucin-1.
The vaccine combination studies whether activating dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer advances.
N-803 is designed to enhance the effects of the vaccines by increasing the proliferation and activation of natural killer and T cells, thereby increasing the potential for cancer prevention in study participants.
"We are excited to partner with the NCI on this important cancer vaccine study to potentially prevent or delay the onset of cancer for people who carry the gene associated with Lynch syndrome," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on April 25, 2023.
"Lynch syndrome affects tens of thousands of people each year, and the average age of cancer diagnosis for them is just 44."
"People known to have the gene for Lynch syndrome can be followed closely by their doctors with regular examinations and scans to watch for cancer development, but, currently, there is no treatment that prevents cancer development in these patients."
Lynch syndrome is one of the most common hereditary cancer syndromes, says the U.S. CDC.
Not only can people with Lynch syndrome develop colorectal cancer some twenty years before the average age of diagnosis for this cancer, but they are also at an increased risk of developing multiple types of other cancers, including endometrial, stomach, ovarian, pancreas, ureter, and renal pelvis, biliary tract, brain, and small intestinal cancers.
Colorectal cancer is the second-deadliest cancer type in the U.S., and approximately 3% to 5% of the 153,000 cases of colorectal cancer annually are thought to be due to Lynch Syndrome.
As are 2% to 3% of all cases of endometrial cancer.
"The Tri-Ad5 vaccine trial will be the largest Lynch syndrome cancer prevention study done in the U.S.," commented Asad Umar, D.V.M., Ph.D., a senior advisor to the director for translational research in NCI's Division of Cancer Prevention and a scientific lead for the trial.
Note: ImmunityBio is also conducting a bladder cancer vaccine study.
