Research & Development
Cellenkos Inc awarded FDA clearance to launch Phase 1 trial of CK0802 for treating COVID-19 associated ARDS
3 June 2020 -

Biotechnology company Cellenkos Inc reported on Tuesday the receipt of approval from the US Food & Drug Administration (FDA) to evaluate CK0802 for treating COVID-19 associated acute respiratory distress syndrome (ARDS) in a randomized, double-blinded, placebo-controlled study.

The company said CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) is a novel allogenic 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 into the tissue.

Treg cells can disarm the cytokine storm via the antigen-presenting cells including the pneumocytes that line the alveolar epithelium and drive the inflammatory reaction. Treg cells in CK0802 express lung homing markers on their cell surfaces, Cellenkos added.

A single manufacturing campaign can result in multiple doses of cryopreserved product that can be shipped to the clinical site, where it can be stored for an extended period or made available for immediate treatment, as needed, concluded the company.

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