Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos), published in peer reviewed journal of Annals of Internal Medicine. Both patients were critically ill and intubated (one on ECMO). Both had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. Patients received cell therapy under FDA Emergency Use IND for up to 3 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 including lactate, C-reactive protein, and Ferritin as well as decreased blood levels of inflammatory cytokines including IL-6, IFNϒ and TNFα .
“We are excited by these early data in very sick patients suffering from COVID-19 ARDS. We recognize that there are several factors at play but believe that the temporal relationship between Treg infusions and patient recovery cannot be ignored,” said Dr. Douglas Gladstone, principal investigator at Johns Hopkins. “We look forward to evaluating this promising therapy in the FDA-approved randomized, double-blinded, placebo-controlled clinical trial of cryopreserved, allogeneic, off-the-shelf, cord blood derived T-regulatory cells (CK0802) in intubated patients suffering from COVID-19 ARDS. Planned correlative assays during this trial will provide insights into the mechanism of action of CK0802 and its relation to clinical outcomes.”
The multicenter clinical trial is set to launch in Q3 2020, with patients assigned to treatment with multiple doses of CK0802 or placebo, with two co-primary outcomes of safety (no severe toxicity) and efficacy (alive and extubated at day 28). CK0802 will be manufactured by Cellenkos® and shipped to the clinical site to be infused at the patient’s bedside.
“We are very encouraged by these early clinical observations and remain fully committed to bring forward this promising, potentially life-saving therapy into market. We believe that our product will materially change the fatal outcome of COVID-19, allowing for the needed (necessary) time to develop an effective COVID-19 vaccine,” said Tara Sadeghi, VP, Clinical Operations at Cellenkos®. “Our company-owned clean room facility allows us to have full control of the manufacturing processes, supply chain, and distribution logistics. We are confident that we can deliver on this multicenter clinical trial.”
Since 2017, the company has owned and operated an independent ISO-7 cleanroom manufacturing facility in Houston, engaged in process development and manufacture of clinical cell therapy products, including testing and quality control. Staffed with experienced personnel, the facility is equipped to support product supply for the clinical trials. Cellenkos already holds two FDA INDs for inflammatory bone marrow failure syndromes and demyelinating polyneuropathy. Cellenkos’ CK0801 cell therapy product has demonstrated a high degree of safety in bone marrow failure syndromes, in the first two dose level cohorts completed to date at The University of Texas MD Anderson Cancer Center (NCT03773393).