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INmune Bio, Inc. Announces FDA Clearance of IND Application for INKmune™, a Natural Killer Therapy, for a Phase I/II Trial in Metastatic Castration-Resistant Prostate Cancer
Represents First Ever Natural Killer Immunotherapy trial in Metastatic Castration-Resistant Prostate CancerWebinar at 11AM ET on Friday, May 12. BOCA RATON,
About this update from Inmune Bio Inc.
[{"type":"text","content":"Represents First Ever Natural Killer Immunotherapy trial in Metastatic Castration-Resistant Prostate CancerWebinar at 11AM ET on Friday, May 12. BOCA RATON, Fla., May 08, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for INKmune™, a novel natural killer (NK) cell immunotherapy, for a Phase I/II open-label clinical trial for the treatment of metastatic Castration-Resistant Prostate Cancer (mCRPC). The Company believes this is the first NK immunotherapy trial in men with mCRPC, which affects more than 80,000 men in the U.S. The trial is expected to enroll the first of 30 patients in the second half of 2023. It will be opened at 4 more clinical study sites, with a goal to determine short and long-term safety of INKmune™, demonstrate the ability of INKmune™ to control prostate cancer tumor burden, and identify a dose of INKmune™ to be used in a future blinded randomized pivotal trial. The principal investigator of the clinical trial is Prof. 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. Prof. Rettig is a consultant to INmune Bio. According to RJ Tesi, MD, CEO of INmune Bio, “Prostate cancer is one of the few solid tumors 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.” This will be the second clinical trial using INKmune™ to treat cancer. The first trial, called Laurel, is an on-going Phase I trial in patients with high risk MDS or AML. Mark Lowdell PhD, CSO of INmune Bio and inventor of the INKmune™ technology said, “There are compelling clinical evidence demonstrating that men with prostate cancer have lots of NK cells in the blood and their tumor, but often these NK cells are resting or immature NK cells that do not kill cancer. INKmune therapy can convert these inert NK into therapeutically relevant and effective NK cells.” Patients will receive one of three doses of INKmune as an out-patient treatment during the six-month trial. Two markers of INKmune™ efficacy will...