INmune Bio Inc. Completes First Cohort and Initiates Second Cohort of Phase 1/2 Study of INKmune Natural Killer Cell Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer - Seite 2

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.

About INKmune

INKmune is an NK cell targeted therapy that is not an NK cell. INKmune is a product designed to improve the function of the patient’s own NK cells. INKmune is a patented, pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination. INKmune is stable at -80^oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. These INKmune-primed NK cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require any type of conditioning, pre-medication, or cytokine support.

About INmune Bio, Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03), Early Alzheimer’s disease, and treatment-resistant depression (XPro). The Natural Killer Cell Priming Platform includes INKmune developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.