On May 8, 2023 INmune Bio, Inc. (NASDAQ: INMB) reported that 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) (Press release, INmune Bio, MAY 8, 2023, View Source [SID1234631168]). 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.
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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 be measured – immunologic and therapeutic efficacy. Immunologic efficacy will measure the increase in memory-like NK cells in the blood and how long those cells are present in the patient’s blood. Therapeutic efficacy will measure tumor response to INKmune therapy, using traditional biomarkers of prostate cancer tumor burden (progression-free survival, changes in blood PSA level, and tumor burden measured by bone and CT scan). Novel biomarkers of tumor response, PMSA PET scan and circulating tumor DNA, will also be studied.
The Company will host a Webinar entitled: INKmune Primed NK cell Therapy for mCRPC on Friday, 12 May at 11 AM EDT on to discuss why INKmune is well suited for the treatment of men with mCRPC and provide details of the clinical trial design. RJ. Tesi, MD will moderate a discussion between Prof. Matt Rettig, MD and Prof. Mark Lowdell, PhD.
To register for the webinar, please sign-up by clicking here or the link below:
About INKmune
INKmune is a product designed to improve the function of the patient’s own NK cells. INKmune is a clinical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune therapy does not require any type of conditioning, pre-medication or cytokine support.