Working with Anne Arundell Medical Center’s James M. Welker as Principal Investigator, biotech sponsor Oncolmmune, Inc. has 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. These 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 approved continuing enrollment while interim analysis occurs.
Most therapeutic strategies targeting COVID-19 emphasize the anti-viral approach to block viral replication and non-anti-viral therapeutics that target host responses responsible for destruction of host organs. The challenge now, according to Oncolmmune’s recent positioning, is that most hospitalized patients have largely cleared the SARS-CoV-2 virus or may have developed immunity to it; hence, non anti-viral strategies are emerging as key approaches to treat 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. This Phase III trial was opened at 10 medical centers nationwide and enroll severe and critical COVID-19 patients that either require supplemental oxygen support, or high flow oxygen non-invasive ventilation. In this study the patients receive a single infusion of CD24Fc or placebo at the beginning of the trial and are followed for up to 28 days thereafter to assess the time to clinical improvement. As the drug works through a novel mechanism that doesn’t duplicate that of other experimental therapeutics, patients enrolled in other clinical trials need not be excluded.
The study includes up to 230 patients randomized, placebo-controlled, double blind, multicenter Phase III trial comparing two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID-19. Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.
· Anne Arundell Medical Center’s principal investigator leads the study—other centers include:
· Baptist Health Research Institute (Jacksonville, FL)
· Martin Army Community Hospital (Fort Benning, GA)
· Institute of Human Virology, University of Maryland (Baltimore, MD)
· Shady Grove Medical Center (Rockville, MD)
· White Oak Medical Center (Silver Spring, MD)
· Henry Ford Health System (Detroit, MI)
· Cooper University Hospital (Camden, NJ)
· Atlantic Health System (Morristown, NJ)
· University Hospitals of Cleveland (Cleveland, OH)
· The Ohio State University Medical Center (Columbus, OH)
· Thomas Jefferson University Medical Center (Philadelphia, PA)
OncoImmune was founded in 2000 and is based in Rockville, Maryland. OncoImmune is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biopharmaceuticals for the treatment of cancer and autoimmune disease. According to website Crunchbase, the company has raised $15.8 million in venture capital. They received $15 million in a Series A round in 2017 by 3E Bioventures. The company’s pipeline can be seen here.
James Welker, MD, Anne Arundel Medical Center