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.
See Also:
A consultant to INmune Bio, Matt Rettig is the principal investigator of the trial.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataINmune 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.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.