ROCKVILLE, Md.–(BUSINESS WIRE)–OncoImmune, Inc. reached an important milestone in its Phase III clinical trial testing the safety and clinical efficacy of CD24Fc for severe and critical COVID-19 patients (SAC-COVID) on June 9, 2020. The first 70 patients have been randomized and received either CD24Fc or placebo as the treatment for severe COVID-19. After reviewing the safety data, the Institutional Review Board has approved continuing enrollment while interim analysis occurs.
Current therapeutic strategies for COVID-19 include use of anti-viral therapies that block viral replication and non-anti-viral therapeutics that target host responses responsible for the destruction of host organs. Since many hospitalized patients have either largely cleared the SARS-CoV-2 virus or may have developed immunity to it, non-antiviral strategies have emerged as an important approach in treating severe and critical COVID-19 patients.
CD24Fc is a first-in-class biologic that fortifies an innate immune checkpoint against excessive inflammation caused by tissue-injuries. The Phase III trial has been opened at 10 medical centers nationwide and enrolls severe and critical COVID-19 patients that either require supplemental oxygen support, or high flow oxygen non-invasive ventilation. The patients receive a single infusion of CD24Fc or placebo at the beginning of the trial and are followed for up for 28 days thereafter to determine the time to clinical improvement. Because the drug works through a novel mechanism that does not duplicate that of other experimental therapeutics, patients enrolled in other trials need not be excluded. The Phase III trial will enroll a total of 230 patients randomized into blinded CD24Fc or placebo arms, with time to clinical improvement from severe or critical to mild symptoms as the primary endpoint (ClinicalTrials.gov Identifier: NCT04317040).
“We have seen neither infusion reactions nor other drug-related adverse events associated with the trial in first 70 patients. The mortality rate so far is 5%, which is considered low among severe and critical COVID-19 patients. The preliminary results show that the safety of the drug is outstanding for this indication,” said Dr. Pan Zheng, MD., PhD, Chief Medical Officer of OncoImmune.
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 Graft versus Host Disease (aGvHD) 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. In addition to the Phase III COVID-19 trial, a Phase III study for the prevention of aGVHD is being opened nationwide.