Immune checkpoint inhibitors (ICIs), such as anti-CTLA-4 and anti-PD-1 monoclonal antibodies, block inhibitory pathways that prevent the immune system from attacking cancer. These drugs essentially take the brakes off of the body's own defenses against  cancer growth and have dramatically altered the landscape for the treatment of refractory tumors.  With several new FDA-approved indications and global market sales projected to exceed $30 billion (USD) in revenue by 2026, ICIs have offered new hope for curative treatment of many advanced malignancies.   However, currently over two-thirds of patients treated with ICIs fail to derive benefit due to inherent or acquired resistance to treatment. 

Preclinical studies have demonstrated that resistance to ICIs can be overcome by a novel, intravenously delivered, stem cell-based therapeutic. This novel stem cell therapy, called iOi7, involves the infusion of a specialized subset of hematopoietic stem cells that convey homing properties to sites of malignant tumor growth and reprogram the tumor microenvironment from an immunosuppressive to immunostimulatory milieu.  We have found iOi7 treatment can reverse treatment resistance to ICIs (i.e. PD-1 blockade) and restore curative responses in multiple preclinical models of invasive chemotherapy-resistant, radiation-resistant, and ICI-resistant malignant brain tumors.  Rapid translation of this breakthrough discovery into first-in-human clinical trials is underway. 

iOncologi Founder and President, Duane A. Mitchell, MD, PhD, is an internationally renowned leader in brain tumor immunotherapy with extensive experience in the immunologic treatment of pediatric and adult brain tumors.  Dr. Mitchell holds four FDA-approved investigational new drug applications (INDs) governing first-in-human immunotherapy treatments. He has pioneered and led ten novel immunotherapy clinical trials based on discoveries made in his research laboratory. His team's work in advancing brain tumor immunotherapy for glioblastoma was recognized as one of the 2016 Top 10 Clinical Research Achievements by the Clinical Research Forum in Washington, D.C.  He is currently the Phyllis Kottler Friedman Professor of Neurosurgery and State of Florida Endowed Chair of Cancer Research at the University of Florida College of Medicine. Dr. Mitchell and Co-Founder and stem cell biologist, Catherine Flores, PhD, have partnered to develop novel stem cell-based immunotherapies for refractory cancers. Dr. Flores received her PhD in stem cell biology from the Imperial College of London, and currently is the Principal Investigator of the Stem Cell Engineering Lab within the UF Brain Tumor Immunotherapy Program.  Dr. Flores' pioneering work on the novel role of stem cells in modulating immune responses has revealed exciting new therapeutic opportunities.  

iOncologi, Inc. is advancing a disruptive treatment paradigm that holds the potential to deliver on the promise of cancer immunotherapy to the many patients who are in dire need of revolutionary medicine.