ROCKVILLE, Md.--(BUSINESS WIRE)--OncoImmune, Inc. initiated its Phase III clinical trial testing the safety and efficacy of CD24Fc in hospitalized COVID-19 patients (SAC-COVID) at the University of Maryland Baltimore Medical Center on April 20, 2020. The national trial will involve at least 10 medical centers throughout the nation. Dr. Shyamasundaran Kottilil, Professor of Medicine, Director, Division of Clinical Care and Research at the Institute of Human Virology at the University of Maryland School of Medicine is the Principal Investigator of the trial and Dr. Joel Chua, Assistant Professor of Medicine, Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine is the clinical principle investigator for the University of Maryland Medical Center. ClinSmart, LLC of Newton, Pennsylvania is the Clinical Research Organization contracted to manage the trial.
The new trial will test the impact of OncoImmune’s flagship product, CD24Fc, in dampening inflammation caused by virus-induced cellar injuries, which is likely a major underlying cause of cytokine storm, immune dysfunction and pneumonia observed in severe COVID-19 patients. A cohort of 230 subjects with severe clinical symptoms will be randomized and administered a single dose of CD24Fc (480 mg by IV infusion) or placebo and followed over a 28-day period to assess safety and efficacy in clinical improvement. As the drug has a novel mechanism of action, it will likely synergize with other drugs, including antiviral treatments such as chloroquine and Remdesivir, or other immune modulators targeting cytokines or their receptors. Therefore, the trial will accept patients undergoing, or intending to enroll in trials testing other experimental therapies.
“OncoImmune is grateful to Dr. Kottilil and the University of Maryland Baltimore for leading the clinical effort,” said Martin Devenport, the Chief-operating Officer of OncoImmune. “It took only 12 days from FDA approval to get the trial started and we could not have achieved this without the dedicated staff from the University and the CRO,” added Raymond Touomou, Vice President for Clinical Operations.
About OncoImmune, Inc.
OncoImmune (www.oncoimmune.com) is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases. OncoImmune is based in Rockville, Maryland.
OncoImmune’s lead product, CD24Fc, is a novel therapeutic that regulates host inflammatory response to tissue injuries and which has broad implications in the pathogenesis of cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GVHD). CD24Fc has completed a Phase IIa trial for the prophylactic treatment of acute GVHD in leukemia patients undergoing hematopoietic stem cell transplantation (HSCT) and resulted in a significant improvement in 180 Day Grade III-IV acute GVHD Free Survival, the Phase III primary endpoint. CD24Fc prophylaxis also resulted in reduced relapse and, compared to match controls, CD24Fc demonstrated improvement in Overall Survival, Non-Relapse Mortality and Relapse-Free Survival. A dose-dependent reduction in severe (Grade > 3) mucositis was also observed. A 20 patient open label dose expansion cohort at the recommended clinical dose is fully enrolled and the drug continues to perform very well. A Phase III study for the prevention of acute GVHD is anticipated to start in mid-2020.