INmune Bio, Inc. continues to advance its Natural Killer (NK) cell therapy, INKmune?, in a Phase I/II trial for men with metastatic castration-resistant prostate cancer (mCRPC). The Company announced the successful completion of the first cohort in the trial. Following review by the Safety Review Committee (SRC), approval has been granted to proceed with the second dose level (cohort 2).

The first patient of the second cohort has been identified and will undergo screening to prepare for treatment. So far, there have been 9 administrations of INKmune in the mCRPC study given as an out-patient with no significant adverse events. When added to the experience with INKmune given in the MDS/AML trial, over 20 infusions of INKmune have been given safely without the need for conditioning therapy, pre-medication, or cytokine support.  The study uses a novel modified Bayesian design that allows for a 3x3 dose escalation design.

Once the Phase I portion is complete, the doses that are safe will be tested simultaneously in the Phase II portion of the trial. Up to 10 patients can be enrolled at each dose level. There are two primary goals of the trial.

The first is to demonstrate the safety of INKmune? in the patient population, - men with mCRPC. 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. The Company has manufactured all planned doses of INKmune, and these have already been released for the entirety of the Phase 1 study. Assays have already been qualified to Phase 2 standard, and the Company has planned the process for BLA-standard validation in 2025.