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INmune Bio Starts Evaluating NK-Based Cell Therapy in Second mCRPC Cohort

NEW YORK – INmune Bio said Monday that it has started enrolling metastatic castration-resistant prostate cancer patients into a second cohort in a clinical trial of its natural killer cell therapy, dubbed INKmune. 

Within the ongoing Phase I/II CaRe PC trial, Boca Raton, Florida-based INmune is studying INKmune as treatment for roughly 30 mCRPC patients who have previously received androgen deprivation therapy and at least one androgen receptor signaling inhibitor. Patients can't have received more than three prior treatments beyond androgen deprivation therapy. 

INKmune is designed to transform resting natural killer cells into memory-like natural killer cells, which can attack patients' tumors. The treatment involves infusing patients with cells from a human tumor cell line, which delivers priming signals to resting natural killer cells. These signals activate costimulatory molecules on the natural killer cells, making them better suited to bind to tumor cells, including those that are otherwise resistant to natural killer cell-mediated lysis. 

In its announcement on Monday, INmune said it successfully completed nine INKmune administrations in the outpatient setting within the first cohort in the trial. None of the patients who have received INKmune so far have experienced significant adverse events or required conditioning therapy, premedication, or cytokine support, according to the firm. 

INmune's primary goal in the CaRe PC trial is to evaluate INKmune's safety and tolerability and to determine the maximum tolerated dose. The firm is also tracking patients' objective response rates and overall survival on the treatment, among other outcomes. 

The firm is using Lantheus' radiolabeled prostate-specific membrane antigen (PSMA)-directed PET imaging agent Pylarify (piflufolastat F 18) to measure PSMA expression in patients' metastatic tumor lesions. INmune will also explore the relationship between patients' tumor responses and changes in circulating tumor DNA levels. 

INmune said it will advance INKmune into blinded, randomized, registration-directed trials based on the results of CaRe PC. 

"Given that prostate cancer has numerous resting NK cells in the tumor microenvironment that do not eliminate cancer, we believe that INKmune, by transforming the patient's NK cells into cancer-killing cells, could potentially be an optimal therapy for prostate cancer," INmune CSO Mark Lowdell said in a statement. 

INmune is also evaluating INKmune as a treatment for certain patients with myelodysplastic syndrome and acute myeloid leukemia. Beyond mCRPC and certain blood cancers, the firm believes INKmune could be used to treat various solid tumors with known natural killer cell resistance, including kidney, ovarian, lung, breast, and nasopharyngeal cancers.