- The first 20 participants have been enrolled in an important national, multicenter trial to test whether ImmunityBio’s Nant Cancer Vaccine (NCV) comprising a tri-valent Adenovirus (Tri-Ad5) in combination with the company’s IL-15 superagonist N-803 could potentially prevent colon and other cancers in individuals with Lynch syndrome. With enrollment of the first two open-label phases of the trial completed, the study will now proceed to the randomized controlled phase.
- When fully enrolled, the completed randomized Phase 2 study will include up to 186 individuals. In the randomized controlled phase 138 participants will be randomized to ImmunityBio’s NCV or placebo.
- Lynch syndrome is associated with a genetic mutation present in an estimated one million Americans1 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.
- This NCV study is the first to evaluate vaccines, delivered by an adenovirus vaccine platform, combined with an immune-enhancer, N-803, to target cancer-specific proteins and activate natural killer (NK) and T cells to prevent cancer.
CULVER CITY, Calif., February 21, 2024 — ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that enrollment and initial follow-up has been completed for the safety portions of a clinical trial that is studying ImmunityBio’s 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. The study, sponsored by the National Cancer Institute, 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.
Each of the three vaccines in Tri-Ad5 targets 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, thereby 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, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “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 (also called hereditary non-polyposis colorectal cancer or HNPCC) is one of the most common hereditary cancer syndromes occurring in 1 in every 300 Americans.2 Not only can people with Lynch syndrome develop colorectal cancer 20 years before the average age of diagnosis for this cancer, 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.3
“We are encouraged by how rapidly this study has been able to enroll participants,” said Asad Umar, D.V.M., Ph.D., a senior advisor to the Director for Translational Research in NCI’s Division of Cancer Prevention (DCP) and a scientific lead for the trial. “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.”
To learn more about this study, please visit https://clinicaltrials.gov/ct2/show/NCT05419011.
For patients interested in enrolling in this study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the website: https://trials.cancer.gov and/or NCIMO_referrals@mail.nih.gov.
ImmunityBio’s Tri-Ad5 Vaccines and N-803 are investigational. Safety and efficacy of these investigational agents have not been established by any Health Authority, including the FDA.
About ImmunityBio’s Tri-Ad5 Vaccines
ImmunityBio’s Tri-Ad5 vaccines target three tumor-associated antigens: brachyury, carcinoembryonic antigen (CEA), and mucin-1 (MUC1). Pre-clinical studies have demonstrated Tri-Ad5 vaccines elicit cytotoxic T cell-mediated tumor cell death and the establishment of memory T cells, and thus may provide protection against the growth and metastasis of cancer. Tri-Ad5 vaccines utilize a second-generation replication-defective human adenovirus serotype 5 (Ad5) vector with viral genes deleted to allow for production of the antigen and a vigorous immune response, without generating a host response to the vector and with the ability to overcome previous adenovirus immunity in cancer patients. Notably, in a phase 1 NCI trial, Tri-Ad5 generated antigen-specific T cells to MUC1, CEA, and/or brachyury in all 10 patients with no evidence of antigenic competition. The safety of multiple ImmunityBio product candidates utilizing the Ad5 technology has been demonstrated in phase 1 and 2 clinical trials for cancers across several tumor types.
About ImmunityBio
ImmunityBio is a vertically-integrated, clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. We are applying our science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
1-3. American Society of Clinical Oncology (ASCO) Cancer.net
Forward Looking Statements
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Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
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Hemanth.Ramaprakash@ImmunityBio.com
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Greg Tenor
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