INmune Bio, Inc. dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023. INmune is a biologic therapy given as out-patient therapy without the need for pre-medication or cytokine support. The study uses a novel modified Bayesian design.

The sequential Phase I dose escalation portion will be followed by a Phase II trial that will simultaneously enroll patients in all dosing cohorts. The second is to determine which dose of INKmune should be used in a blinded, randomized registration trial. Determining the best dose of INKmune to use in future clinical trials will depend on a combination of immunologic and anti-tumor responses seen in the men treated with INKmune therapy.

INKmune is an NK cell targeted therapy that is not an NK cell. INKmune therapy does not require any type of conditioning, pre-medicated or cytokine support.