Laboratory company Cellenkos Inc announced on Monday that Johns Hopkins University Hospital has announced encouraging data from the treatment of COVID-19 induced acute respiratory distress syndrome with the company's allogeneic, cord blood derived T-regulatory (Treg) cell therapy.
Patients who were critically ill and intubated, had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. These patients received cell therapy under US FDA Emergency Use IND for up to three doses. Clinical improvement was evident within 48 hours of first infusion and correlated with concurrent dampening of the cytokine storm as demonstrated by a rapid decline in peripheral biomarkers .
Cellenkos said a multicentre clinical trial will be launched in the third quarter of 2020, with patients assigned to treatment with multiple doses of CK0802 or placebo, with two co-primary outcomes of safety and efficacy. CK0802 will shipped from the company to the clinical site at the patient's bedside. The trial will examine safety and efficacy in the treatment of COVID-19 ARDS. There were a total of 11,565,414 COVID-19 cases confirmed globally with 536,649 deaths as of 6 July 2020.
The company stated that CK0802 is a novel allogenic, off the shelf, cell therapy product consisting of Treg cells derived from clinical-grade umbilical cord blood units and manufactured using its proprietary process. The product is cryopreserved and readily available off-the-shelf, without any requirement for HLA matching and is infused intravenously.
Personalis validates NeXT Personal test for ultra-sensitive MRD detection
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval
Lipocine doses first cohort in LPCN 1154 study
Poseida Therapeutics names new chief medical officer
Biocytogen and ABL Bio collaborate on development of new bispecific antibody-drug conjugates