Cancer cells evolve to avoid immune responses from the human body. An example of such evolution is suppressing the expression of major histocompatibility complex (MHC) molecules that are required for antigen recognition by T-cells.
To overcome this issue, research is now being conducted regarding technologies to artificially introduce CARs into a patient’s T-cells so that cancer cells can be recognized without requiring MHC molecules.
Although the FDA has approved several CD19-targeted CAR-T cell therapeutics for blood cancer, there is an unmet need for CAR-T cell therapeutics targeting solid tumors.
Currently, preclinical trials have been completed and preparations for FDA phase I clinical trial are underway. Efforts are being taken to shorten the clinical development period by applying for breakthrough therapy status or orphan drug designation from the FDA with the goal of early market release.