INKmune is intended to treat metastatic Castration-Resistant Prostate Cancer. Credit: Nemes Laszlo via

The US Food and Drug Administration (FDA) has granted clearance to INmune Bio’s investigational new drug (IND) application enabling initiation of a Phase I/II clinical trial of INKmune, a natural killer (NK) cell immunotherapy, to treat metastatic castration-resistant prostate cancer. 

The open-label, six-month trial will randomise patients to receive one of three doses of INKmune, as an outpatient treatment.

Immunologic and therapeutic efficacy are the two markers to be measured during the study period.

Immunologic efficacy will measure the memory-like NK cells increase in the blood while therapeutic efficacy will measure tumour response to INKmune therapy.

The trial will also study PMSA PET scan and circulating tumour DNA and novel biomarkers of tumour response.

A consultant to INmune Bio, Matt Rettig is the principal investigator of the trial.

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INmune Bio CEO RJ Tesi said: “Prostate cancer is one of the few solid tumours that has no immunotherapy options and chemotherapy, the standard-of-care, has suboptimal efficacy with measurable toxicities. 

“INKmune has the potential to provide a safe and effective therapeutic option for men with this difficult disease.”

The company plans to enrol the first of 30 patients in the second half of this year and expand the trial at four more clinical sites.

The goal of the expansion is to demonstrate short and long-term safety, the ability to control prostate cancer tumour burden and identify a dose of INKmune, which will be used in a further blinded randomised pivotal trial.

INKmune is delivered by a simple IV infusion to improve the function of the patient’s own NK cells. 

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