LADD means that JNJ-64041757 is produced by deleting two genes from the bacteria that control its ability to infect cells and spread. This minimizes the risk of infection without compromising the potential therapeutic benefits the vaccine may offer.
How JNJ-64041757 works
JNJ-64041757 is based on attenuated strains of a bacteria called Listeria monocytogenes that produce the tumor antigens epidermal growth factor receptor mutant form 8 (EGFR8) and human mesothelin. Antigens are substances that are not normally present in the body and therefore able to trigger an immune response.
EGFR8 and mesothelin are found in high levels in many types of cancer, including NSCLC,
Upon administration, the attenuated bacteria in the vaccine are taken up by certain immune cells called dendritic cells. Here, they are processed and the EGFR8 and mesothelin antigens are presented to and recognized by another type of specialized immune cells called cytotoxic T-lymphocytes (CTLs). CTLs initiate a potent immune response against EGFR8- and mesothelin-containing tumor cells, eventually resulting in tumor cell death.
JNJ-64041757 in clinical trials
The safety and effectiveness of JNJ-64041757 in treating advanced or metastatic NSCLC are being evaluated in an open-label Phase 1 clinical trial (NCT02592967). The study is currently recruiting patients across the U.S. and is expected to enroll up to 42 patients.
Approximately 12 patients will participate in the dose escalation portion of the trial where two dose levels of JNJ-64041757 will be evaluated for safety and effectiveness The other participants will enter into the expansion phase to further characterize the safety and preliminary immunological and clinical activity of the vaccine.
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