OncoImmune has received a study-may-proceed letter from the FDA for its Phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients (SAC-COVID).

A cohort of 230 subjects with severe clinical symptoms will be randomized and administered a single dose of CD24Fc (480 mg IV infusion) or placebo and followed for a 14-day period to assess safety and efficacy in clinical improvement.

The SAC-COVID trial consists of two interim analyses, respectively, for safety and therapeutic activity, and for therapeutic efficacy. This is a double blind, randomized, multi-center clinical trial.

SARS-CoV-2 causes clinical symptoms by killing cells in the lung and by causing inflammation that further exacerbates clinical symptoms. "In addition to anti-viral therapy, a comprehensive strategy in treating COVID-19 patients should include a non-antiviral approach targeting the tissue injury-induced inflammation", said Dr. Pan Zheng, Chief Medical Officer and co-founder of OncoImmune. CD24Fc will be tested in combination with the best available therapy. Patients receiving other experimental therapies are welcome to participate in the trial.

"CD24Fc is a first-in-class biologic that fortifies an innate immune checkpoint against excessive inflammation caused by tissue-injuries. We are very excited to launch a global effort to test the clinical efficacy of CD24Fc in speeding up recovery of hospitalized COVID-19 patients", said Dr. Yang Liu, CEO and co-founder.

OncoImmune 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 syndromes 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 aGVHD is anticipated to start in mid-2020.

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