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INmune Bio, Inc. Announces Submission of Investigational New Drug (IND) Application for INKmune™ to the U.S. Food and Drug Administration for Treatment of Metastatic Castration-Resistant Prostate Cancer
BOCA RATON, Fla., April 03, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on
About this update from Inmune Bio Inc.
[{"type":"text","content":"BOCA RATON, Fla., April 03, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of INKmune™ to treat metastatic castration-resistant prostate cancer (mCRPC). “We believe this IND highlights the potential for INKmune™, our natural killer cell targeting immunotherapy, to treat solid tumors,” said RJ Tesi M.D., CEO of INmune Bio. “We believe INKmune™ provides a new treatment option that may allow men with mCRPC to safely avoid cytotoxic chemotherapy and potentially live longer.” The trial is expected to take place in four or more medical centers in the U.S and will enroll approximately 30 patients in a flexible Bayesian design. Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer, will be Principal Investigator of the INKmune™ mCRPC trial. The goal of the trial is to define the safety of INKmune and demonstrate the ability of INKmune-primed NK cells to attack prostate cancer. The results should allow us to choose the best dose of INKmune™ to move into a blinded randomized trial. Given the novel nature of the treatment, the Company expects a period of consultation with the FDA prior to initiating the planned trial. “NK cells are often seen in prostate tumor biopsies, but in many cases the cancer cells appear to be resistant to NK killing,” said Mark Lowdell Ph.D., CSO of INmune Bio and inventor of the INKmune™ technology. “The Company believes that INKmune can convert the patient’s own NK cells into cancer killing memory-like NK (mlNK) cells that can survive in the hostile immunosuppressive and hypoxic tumor microenvironment (TME) that as we have shown in vitro, can kill NK-resistant prostate cancer cells.” The 6-month trial will test three doses of INKmune™. The therapeutic potential of INKmune™ in mCRPC will be tested in two ways. First, the immunologic effects of INKmune™ therapy will be measured by the ability of INKmune™ to convert the patient’s resting NK cells into cancer killing memor...