ImmunityBio has initiated a Phase llb trial to evaluate its Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) with its IL-15 superagonist N-803 to treat people with Lynch syndrome, a hereditary cancer syndrome.
Sponsored by the National Cancer Institute, the trial will examine the efficacy of Tri-Ad5 plus N-803 in preventing colorectal and other cancers.
Each of the three vaccines in Tri-Ad5 has been designed to target different proteins related to pre-cancer and cancer cells.
N-803 is capable of improving the effects of the vaccines by increasing the expansion and activation of natural killer (NK) and T cells, thereby raising the possibility of preventing cancer among the patients of the trial.
The randomised, parallel assignment trial expects to include 186 subjects at 14 centres across the US.
It is anticipated to be completed by 1 February 2027.
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By GlobalDataImmunityBio executive chairman and global chief scientific and medical officer Patrick Soon-Shiong said: “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 the development of cancer, but currently, there is no treatment that prevents the development of cancer in these patients.
“We hope to change that with this innovative study developed by the NCI.”