The US Food and Drug Administration (FDA) has granted approval for OncoImmune to conduct a Phase III clinical trial of CD24Fc to treat patients hospitalised with Covid-19.

CD24Fc is designed to modulate host inflammatory response to tissue injuries which is believed to be involved in autoimmune disease, cancer, graft-versus-host disease (GvHD) and metabolic syndromes.

The novel coronavirus, SARS-CoV-2, leads to clinical symptoms by killing the lung cells. It also causes inflammation that worsens clinical symptoms.

OncoImmune co-founder and CEO Dr Yang Liu said: “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 hospitalised Covid-19 patients.”

In the new double blind, randomised, multi-centre Phase III trial, CD24Fc’s safety and efficacy will be assessed in around 230 patients exhibiting severe clinical symptoms.

Participants will receive a single 480mg IV infusion of the drug candidate or placebo. Named SAC-COVID, the trial involves a follow-up of 14-days to monitor safety and efficacy in clinical improvement.

The study involves two interim analyses for safety and therapeutic activity, and for therapeutic efficacy, respectively.

CD24Fc will be given in combination with the ‘best available’ treatment, said the company. Patients who are on other experimental therapies can also enrol in the trial.

OncoImmune co-founder and chief medical officer Dr Pan Zheng said: “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.”

Previously, the drug candidate was assessed in a Phase IIa trial for prophylaxis of acute GvHD in leukaemia patients receiving hematopoietic stem cell transplantation (HSCT).

Data showed a significant improvement in 180 Day Grade III-IV acute GVHD Free survival.