INmune Bio (NASDAQ: INMB), a clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease, announced that its Investigational New Drug (“IND”) application for INKmune(TM), a novel natural killer (“NK”) cell immunotherapy, has been cleared by the U.S. Food and Drug Administration (“FDA”) for a phase 1/2 open-label clinical trial for the treatment of metastatic castration-resistant prostate cancer (“mCRPC”). According to the announcement, this is the first NK immunotherapy trial in men with mCRPC, as far as the company is aware.

The trial, which will begin enrolling patients later this year, will focus on determining short- and long-term safety of INKmune along with demonstrating the ability of the immunotherapy to control prostate cancer tumor burden and identifying the dosage for use in a future blinded, randomized pivotal trial. Compelling clinical evidence shows that men with prostate cancer have significant amounts of NK cells in their blood and their tumors, but these NK cells are either immature or resting and, consequently, do not kill cancer. INKmune therapy is designed to “convert these inert NK into therapeutically relevant and effective NK cells.”

The principal investigator of the clinical trial is Matt Rettig, MD, a 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. He is also a consultant to 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,” said INmune Bio CEO RJ Tesi, MD in the press release. “INKmune has the potential to provide a safe and effective therapeutic option for men with this difficult disease.”

The company also announced an upcoming webinar, titled INKmune Primed NK Cell Therapy for mCRPC. Slated to being at 11 a.m. EDT on May 12, 2023, the webinar will include a discussion between Prof. Rettig, MD and Prof. Mark Lowdell, PhD; Tesi, MD will moderate the event. The discussion will center on why INKmune is ideally suited for the treatment of men with mCRPC. They will also explain more specific details of the clinical trial design. 

To attend the webinar, visit https://ibn.fm/HayGE

To view the full press release, visit https://ibn.fm/vfb7o

About INmune Bio, Inc. 

INmune Bio is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03(TM)), Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment-resistant depression (XPro(TM)). The Natural Killer Cell Priming Platform includes INKmune(TM) developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. For more information about the company, visit www.INmuneBio.com.

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