INmune Bio has dosed the first subject in a Phase I/II trial of new biologic therapy, INKmune, to treat patients with metastatic castration-resistant prostate cancer (mCRPC).

Named CaRe PC, the open-label study will analyse up to three dose levels of INKmune, which is administered as an outpatient therapy through intravenous dosing.

The trial will monitor immunologic responses, including variation in the number of tumour-killing memory-like NK cells.

It will also assess anti-tumour responses by monitoring prostatic surface antigen (PSA) levels in the blood, and metastatic lesion analysis using artificial intelligence (AI).

The CaRe PC trial will enrol nearly 30 subjects across low, medium, and high dosing cohorts.

It employs a modified Bayesian design, with a sequential Phase I dose escalation, followed by a Phase II trial that will test the safe doses simultaneously.

The primary goals are to confirm INKmune safety and to determine the optimal dose for a blinded, randomised trial.

Determining the best dose for usage in trials in the future will be based on a mixture of immunologic and anti-tumour responses observed in trial subjects.

INmune Bio CSO and INKmune inventor professor Mark Lowdell said: “There are two key elements for successful immunotherapy. There must be immune cells in the tumour and the drug must convert those immune cells into cancer killing cells.

“Prostate cancer has many resting NK cells, and we believe INKmune will convert those resting NK cells into memory-like NK cells that can attack the tumour.”

INmune Bio develops therapies that act on the innate immune system to fight ailments.

The company has two product platforms in the clinic: The Dominant-Negative Tumour Necrosis Factor (DN-TNF) product platform, and the Natural Killer Cell Priming Platform.

INKmune is part of the Natural Killer Cell Priming Platform.

DN-TNF candidates are being analysed to treat cancer (INB03), early Alzheimer’s disease, and treatment-resistant depression (XPro).