INmune Bio Granted Phase I Clinical Trial Authorization of Lead Product INKmune™ in Refractory and Recurrent Ovarian Cancer Patients


LA JOLLA, California, Dec. 19, 2018 (GLOBE NEWSWIRE) -- INmune Bio Inc., an immunotherapy company developing treatments to reprogram the innate immune system to fight disease, announced today that it has been granted Clinical Trial Authorization (CTA) by the United Kingdom (UK) regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA), for a Phase I clinical trial of its lead therapeutic candidate INKmune™. The innate immune drug will be used to treat relapsed and refractory ovarian cancer in a UK based trial.

“The CTA approval for the first clinical trial of INKmune is a major milestone for the company,” said RJ Tesi, M.D, chief executive officer and co-founder of INmune Bio. “INKmune is our second cancer program to enter the clinic and will be tested in women with relapsed and refractory ovarian cancer, which accounts for more deaths than any other cancer of the female reproductive system.”

Modern cancer therapy strives to harness the patient’s immune system to help control the cancer. Natural killer (NK) cells of the innate immune system must function normally to eliminate residual disease – the cancer left over after traditional cancer therapy that is the cause of cancer relapse. INKmune is a novel cancer therapy that may switch on the patient’s NK cells to attack residual disease that can be the cause of treatment failure.

“This approval represents external validation of our pre-clinical data set using Tumor Primed NK cells against a range of cancer cells which are insensitive to NK killing,” says Dr. Mark Lowdell, chief scientific officer and co-founder of INmune Bio. “The way that INKmune activates the patient’s own immune system means that it could be used for many types of cancer; women with ovarian cancer are just the first of many patients we hope to treat with INKmune."

Today, ovarian cancer ranks fifth in cancer deaths among women. In 2018 alone, the American Cancer Society estimated 22,240 new cases in the US. Unfortunately, when ovarian cancer relapse occurs, the average survival is between 12 to 18 months, and fewer than 1 in 10 patients survive beyond five years following standard chemotherapy treatment.

About INmune Bio, Inc.

INmune Bio, Inc. is a clinical-stage biotechnology company developing therapies targeting the innate immune system in cancer. INmune Bio is developing two products platforms that reengineer the patient’s innate immune system’s response to their cancer, INKmune™ and INB03. INKmune is an NK cell therapeutic that primes the patient’s NK cells to attack their cancer. INB03 inhibits myeloid derived suppressor cells, which often cause resistance to immunotherapy, such as anti-PD1 checkpoint inhibitors. INmune Bio’s product platforms target residual disease and utilize a precision medicine approach for treatment of a wide variety of hematologic malignancies and solid tumors. To learn more, please visit

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