ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial

ImmunityBio has announced that enrollment and initial follow-up has been completed for the safety portions of a cancer vaccine trial which will test the efficacy of its Nant Cancer Vaccine (NCV) in participants with Lynch syndrome, according to a company press release.¹

ImmunityBio’s investigational cancer vaccine, NCV, is a tri-valent combination of antigens delivered by a second-generation Adenovirus vector (Tri-Ad5 CEA/MUC1/brachyury) and will be tested together with its IL-15 superagonist N-803.

The three vaccines in Tri-Ad5 target different proteins associated with precancer and cancer cells. The vaccine combination is studying whether activation of 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 proliferation and activation of natural killer (NK) and T cells, increasing the potential for cancer prevention in study participants.

“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, MD, executive chairman and global chief scientific and medical officer, ImmunityBio in the press release. “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.”

According to the American Society of Clinical Oncology, Lynch syndrome is a type of inherited cancer syndrome associated with a genetic predisposition to different cancer types. This puts people with Lynch syndrome at higher risk for certain types of cancer. Approximately 3 percent of all cases of colorectal cancer and 2 to 3 percent of all cases of endometrial cancer are thought to be due to Lynch syndrome.²

The study, sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, will include up to 186 participants when fully enrolled and is now open to the randomized controlled portion of the trial. In the randomized Phase II clinical trial, 138 participants will be randomized to ImmunityBio’s NCV or placebo.

“We are encouraged by how rapidly this study has been able to enroll participants,” said Asad Umar, DVM, PhD, a senior advisor to the director for translational research in NCI’s Division of Cancer Prevention and a scientific lead for the trial in the press release. “It is a strong indication of an unmet need and of the willingness of participants to help science make new discoveries in the area of cancer prevention.”

According to the press release, this study of NCV is the first to evaluate vaccines delivered by an adenovirus vaccine platform, combined with an immune-enhancer to target cancer-specific proteins and activate NK and T cells to prevent cancer.

References

1. ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial in Participants with Lynch Syndrome and Initiation of Randomized Controlled Phase of the Trial. News release. February 21, 2024. Accessed February 22, 2024. https://www.businesswire.com/news/home/20240221666790/en
2. Lynch Syndrome. American Society of Clinical Oncology. July 2023. Accessed February 22, 2024. https://www.cancer.net/cancer-types/lynch-syndrome