On April 3, 2023 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, reported 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) (Press release, INmune Bio, APR 3, 2023, View Source [SID1234629747]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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 memory-like NK cells, the ability of those cells to kill a tumor target (RAJI cell line) in vitro and the persistence of that response after treatment. Second, the tumor response to INKmune therapy will be measured using traditional biomarkers of prostate cancer response – progression free survival, changes in blood PSA level and imaging studies (bone and CT scan). Novel biomarkers of tumor response, change in PMSA PET scan and circulating tumor DNA, will also be studied.
Currently, in INmune’s ongoing Laurel INKmune trial, the Company’s MDS/AML INKmune Phase 1 program, the latest patient treated at the Royal Hallamshire Hospital at Sheffield University Medical School finished INKmune treatment without side effects. Initial biomarker data from this patient show, as in previous patients, that she has developed tumor killing memory-like NK cells in her peripheral blood one week after the first dose. Analysis of her later blood samples is underway. The clinical sites continue to review patients for treatment in the Laurel trial. An additional patient will be eligible for treatment in three weeks.
About INKmune
INKmune is an NK cell targeted therapy that is not an NK cell per se but a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells in the patient and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination; it is a pseudokine. These INKmune-generated 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.