OncoImmune, a pharmaceutical company engaged in making immunotherapies for cancer, autoimmune diseases, and inflammation, has reportedly announced that it has reached a crucial milestone in Phase 3 clinical study that is testing the clinical efficacy and safety of CD24Fc for critical and severe COVID-19 patients on June 9, 2020.

The initial 70 infected people have been randomized and given either placebo or CD24Fc as a treatment option for critical coronavirus. After evaluating the safety information, the Institutional Review Board has authorized the continuation of registration while interim analysis takes place.

Current therapeutic coronavirus strategies include the use of non-anti-viral therapies that attack host responses which are responsible for destroying host organs and anti-viral therapeutics that hamper viral replication. Since several infected patients either have largely cleared the virus or might have developed immunity against it, non-antiviral therapies have emerged as a crucial approach to treat critical and severe COVID-19 patients.

CD24Fc is the first biologic that consolidates an innate immune checkpoint to excessive inflammation caused due to tissue-injuries. The Phase 3 trial it being carried out at 10 medical centers across the nation and enrolls critical and severe COVID-19 patients that either need high flow oxygen non-invasive ventilation or supplemental oxygen support.

The infected patients get one infusion of placebo or CD24Fc at the start of the trial and are checked upon for the next 28 days to confirm the time required for clinical improvement. Since the drug works via a novel mechanism that does not replicate that of other experimental therapies, patients registered in other studies would not be excluded. This trial would enroll 230 patients that would receive placebo arms or blinded CD24Fc, with a certain time for clinical improvement from critical or severe to mild symptoms as the primary endpoint.

Chief Medical Officer of OncoImmune, Dr. Pan Zheng, PhD., MD., stated that the company has neither seen any adverse events related to the drug nor any infusion reactions due to the drug in the initial 70 participants. The rate of mortality is at 5% so far, which is viewed to be low among critical and severe COVID-19 patients. Preliminary outcomes show that the drug safety is outstanding for the indication. 

Source credit: https://www.businesswire.com/news/home/20200614005028/en/OncoImmune-Reports-Progress-Phase-III-Clinical-Trial