Cancer Prevention Study Targets People with Hereditary Risk

ImmunityBio today announced that enrollment and initial follow-up have been completed for the safety portions of a phase 2b clinical trial that is studying an investigational cancer vaccine of a tri-valent combination of antigens delivered by a second-generation Adenovirus vector (Tri-Ad5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803 for participants with Lynch syndrome.

Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells.

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 occurs.

The IL-15 superagonist 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.

The study will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial.

“We are pleased to be selected to participate in this important and innovative cancer prevention study, one that could provide insights into how the immune system could be harnessed to prevent cancer in individuals with hereditary risk,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on February 21, 2024.

“With an estimated 5 to 10 percent of cancers inherited, understanding mechanisms that might prevent or delay their onset could potentially change the prospects for tens of thousands of people annually.”

Lynch syndrome is associated with a genetic mutation present in an estimated one million Americans who are more likely to be diagnosed with cancer at a younger age and are at increased risk of developing multiple types of cancers during their lifetime.

ImmunityBio’s Tri-Ad5 Vaccines and N-803 are investigational and are not commercially approved. The safety and efficacy of these investigational agents have not been established by any Health Authority, including the U.S. FDA.

The National Cancer Institute sponsors this study.