Cellenkos, an early stage clinical biotechnology company, has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to proceed with a phase I clinical trial of CK0801, third party cord blood derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anaemia, myelodysplastic syndrome and myelofibrosis, it was reported yesterday.

The company submitted its IND application on 11 May 2018. The Phase one clinical trial of CK0801 is to commence in the third quarter of 2018 at The University of Texas MD Anderson Cancer Center, Houston, Texas.

CK0801, is a first-in-class, cord blood-derived T-regulatory cellular product, produced using Cellenkos's proprietary manufacturing platform, which overcomes immune dysfunction by inhibiting key regulators of inflammation. It contains healthy and robust regulatory T cells derived from donor cord blood units, and adoptive therapy with CK0801 is said to have the potential to replenish the immune system and impact patient care by providing novel, non-pharmacologic options. It will be manufactured at the Cellenkos FDA registered manufacturing facility located in Houston, Texas.